Government of Jammu and Kashmir is currently in the process of framing a Drug Policy for this state. An exercise that was started a couple of years back by the Ministry of Health and Family Welfare is about to reach its logical conclusion. In this connection a draft of the proposed drug policy was published by the ministry in local newspapers and also uploaded on its official website. Per se the draft looks quite comprehensive but there are several important areas that have been left unattended. Keeping in view the impact of those missing vital policy inputs
\, it is necessary that these deficiencies are adequately addressed in right earnest before a final shape is given to the proposed policy so that the health and welfare of common masses does not get jeopardized in any manner whatsoever.
Need for intelligence and legal cells
At present inspectorate staff working under Drug and Food Control Organization (DFCO) is not only levied with the task of conducting inspections, lifting samples of drugs for analysis, recommending cases for grant or renewal of various licenses but also have to investigate rackets of spurious and sub-standard drugs operational in their jurisdiction areas, launch prosecutions in the courts of law against breach of any provisions of the Drugs and Cosmetics Act, 1940 and even plead their cases themselves in absence of any adequate legal assistance. Consequently they have to spend most of their time in court hearings thus adversely affecting their devotion towards main duties assigned to them. As such need of the hour is to establish intelligence cells in every district of the state to assist the inspectorate in investigating and busting any rackets of spurious/sub-standard drug trade flourishing in their jurisdiction areas with provision of lucrative incentives for informers. Similarly establishment of legal cells will allow the inspectorate to devote maximum time to their main duties of enforcing provisions of the Drugs and Cosmetics Act, 1940 effectively. Additionally court cases will be better pleaded by legal experts and the conviction rate will rise steeply which is otherwise at its lowest ebb at present due to lack of suitable expertise in courts. As such this provision needs to be included in the proposed Drug Policy of the J&K state.
Delegation of powers under Essential Commodities Act
In order for the drug inspectorate staff to be able to book the culprits found overcharging patients on sale of medicines, they need to be notified under Essential Commodities Act, without which they cannot enforce the provisions of Drug Prices Control Order, 1995. However it is mandatory to accord them gazetted status in order to make them eligible to be notified as authorized officers under Essential Commodities Act. At present any prosecution in respect of overcharging on drugs has to be instituted by an officer of the rank of an Assistant Controller or Deputy Controller of DFCO, J&K which delays the matters inordinately since Drug Inspectors are not in a position to take necessary action as warranted under rules against any breach of the Drug Price Control Order. Therefore the upcoming drug policy should ensure that the required cadre is accorded to the inspectorate staff so that they are notified under EC Act and are suitably empowered to enforce the provisions of DPCO, 1995 failing which some unscrupulous chemists will continue to charge the patients as per their own whims and fancies thus putting an additional burden on the already straining pockets of poor patients.
Implementation of provisions relating to AYUSH drugs
Over the past few years, use of drugs belonging to indigenous systems of medicine like Ayurveda, Unani, Siddha and Homeopathy (AYUSH) has gained wide popularity among masses and a large chunk of population is resorting to these forms of treatment for seeking a cure to their ailments. J&K State too has witnessed a massive growth of sale outlets dealing with drugs belonging to one or more of these systems of medicine. However surprisingly there are absolutely no legal or statutory frameworks and mechanisms in place to control, govern, monitor and regulate the sale, storage or distribution of such drugs including licensing of such drug sale outlets. Even the necessary powers to enforce these provisions have not been delegated to the inspectorate staff available at present with the DFCO of J&K. At present DFCO issues a few limited licenses only in respect of Unani drugs and there are no provisions for other systems of medicine.
As a result mushroom growth of unlicensed Ayurvedic drug sale outlets has become a big nuisance along the length and breadth of the state. Anybody feels free to open an Ayurvedic or Homeopathic drug store in any part of the state and sell, store or distribute such drugs without any license, regular monitoring and supervision from Drug Control authorities. Therefore it should be a priority of the state govt. to immediately enforce provisions relating to the manufacture, sale, storage and distribution of such drugs as provided under chapter IV-A of the Drugs and Cosmetics Act of 1940 and thereby bring drug sale, storage and distribution of alternative systems of medicine also under the ambit of Drug and Food Control Organization. Adequate powers should be vested upon the existing staff in this regard until further augmentation is made possible. Draft Drug Policy is surprisingly silent about this issue and lays no stress on enforcement of these provisions and delegation of necessary powers to the available staff. Therefore this aspect needs to be revisited in the draft drug policy of the J&K govt., otherwise the sorry state of affairs will continue even after a new drug policy is promulgated in the state.
Implementation of provisions relating to Cosmetics
Similarly provisions of Drugs and Cosmetics Act, 1940 dealing with manufacture, sale, storage and distribution of cosmetics also need to be enforced to the possible extent in due course of time, since at present there is no regulatory framework or apparatus in place that could govern these aspects of trade in Cosmetics which is a flourishing industry and lack of any regulatory control has led to flooding of markets with spurious and sub-standard cosmetics.
Strengthening of infrastructure for enforcement of NDPS, 1985
Reports of widespread drug addiction and abuse of prohibited medicines have been pouring in from various parts of the state over the last few years. A tough and stringent piece of legislation namely Narcotic Drugs and Psychotropic Substances (NDPS) Act has been enacted in 1985 to help curb the scourge of drug abuse. Act is a central Act and extends to the state of Jammu and Kashmir too. Most significant feature of the Act is the exemplary punishment provided for most of the offences. The Act is however chiefly enforced by the Narcotics Control Bureau (NCB) whose workforce is very meager and needs expansion. Though this Bureau has a nodal centre at Jammu, there is none in the valley making its activities imperceptible. More people possessing degrees in Pharmaceutical Sciences need to be appointed as enforcement officers under the Act for an efficient and foolproof administration of its provisions. Further a multi-disciplinary level Coordination Committee under the Chairmanship of Chief Secretary or a senior Secretary has to be established for regular interaction with various Central and State agencies, to receive support and grant-in-aid assistance from the Narcotics Control Bureau of India. Additionally our state also has to set up an Anti Narcotics Task Force under an IG level officer with duties and responsibilities duly demarcated. In absence of such a committee and task force, this state will not be eligible to receive financial assistance and other support from NCBI. Thus this aspect too needs to be attended to in the Draft Drug Policy of the state.
Quality Control of drugs and Pharmacy Services in hospitals
Though draft drug policy envisages to upgrade and modernize the govt. drug testing laboratories of the state and involve private sector laboratories too, it ignores the importance of establishing in-house quality control cells within hospitals for testing the hospital drug supplies on regular basis by a qualified pharmacist. Similarly no thrust is given to other clinical pharmacy services that could be rendered by qualified and trained pharmacists in the hospitals to further the cause of better pharmaceutical care of the patients. Medical Council of India has put forth certain guidelines with regards minimum requirement of qualified pharmacists in hospitals that have been ignored altogether in the draft policy and need to be implemented. National Human Rights Commission in its report on hospital pharmacy services submitted in January, 1999 has also recommended that, “every hospital should organize the pharmaceutical activities in regard to purchase, storage, testing, compounding, dispensing and distribution of drugs under the charge of a competent and experienced persons possessing at least degree in pharmacy”. In accordance with these guidelines and the recommendations made vide Hathi Committee Report (1975), it is imperative that the requirements as per MCI guidelines be fulfilled and necessary mechanism devised in the draft drug policy.
Further services of at least one pharmacy graduate should be made available at every primary health centre, sub-district and district hospital of the state. Draft drug policy of the state must make it mandatory to engage qualified pharmacy personnel at all primary, secondary and tertiary care hospitals of the state. It is only professionally trained and legally qualified pharmacy personnel who could assist the doctors in counselling and disseminating information to patients on matters like indications of the drug, its contra-indications, adverse effects, precautions, dosage etc and could also play their legitimate and pivotal role in procurement, testing, storage and dispensing of standard quality drugs in every hospital and primary health centre.
Enforcement of central Pharmacy Act, 1940
Draft drug policy of the J&K state makes no mention of enforcement of central Pharmacy Act in the state. Just the way central Drugs and Cosmetics Act, 1940 has been enforced in the state, central Pharmacy Act of 1948 too needs to be promulgated in place of J&K Pharmacy Act 2011 (samvat). Draft drug policy of the J&K govt. is silent about this issue too. This will bring all pharmacy academic institutions of the state under the purview of the Pharmacy Council of India, help our pharmacists get registered in the Central Register and practice pharmacy profession anywhere in India. Besides it will also enable our pharmacy institutions seek financial assistance from central councils, organize and participate in their continuing education programmes, seminars etc and achieve national and international level standards in our pharmacy and health education. At present no educational institution imparting degree or diploma course in Pharmacy within the state of J&K falls under the purview and influence of the Pharmacy Council of India due to this lacuna that has been brazenly ignored in the draft policy.
Constitution and functioning of the J&K Pharmacy Council
Draft drug policy of the J&K state makes no mention of enforcement of Education Regulations or framing Executive Committee in the state. The Jammu and Kashmir Pharmacy Council has been constituted a few years ago. So far, Council has prepared the first and subsequent registers of those pharmacists who have been carrying on the business or profession of pharmacy in J&K. As a next step, it has to frame an Executive Committee and regulate pharmacy education in the state by way of enforcement of Education Regulations as provided under section 10 of the J&K Pharmacy Act 2011 (samvat). Thereunder it can prescribe the minimum standards of education required for qualification as a pharmacist and can also prescribe the nature and period of study and of practical training to be undertaken before admission to the qualifying examination for a degree or diploma in pharmacy. In absence of Education Regulations there is no binding at present on pharmacy educational institutions to observe and follow any set standards.
Once Education Regulations come into force, no person other than a diploma or a degree holder in pharmacy should be designated or registered as a pharmacist and a target date should be fixed beyond which drug trade should be strictly restricted to diploma or degree holders in pharmacy only. In order to cater to the requirement of qualified pharmacy personnel for such endeavor, diploma course in pharmacy may be commenced at govt. polytechnics in Jammu and Srinagar after appointing teaching staff and making other necessary facilities available for the purpose.
Furthermore wider participation of the pharmacy professionals drawn from various sections like academia, clinical set up, regulatory affairs, industry as well as sales and marketing in the affairs of the J&K Pharmacy Council shall pave way for its better functioning, improved outcome and greater acceptance of its policies. Its working should not be confined to any one department of the state administration. Since its decisions affect the entire profession, it calls for a broader representation to all concerned as is true with state pharmacy councils of all other states.
Other issues not addressed by the draft drug policy:
Draft drug policy published by the J&K government is also silent about many other issues like the modalities of training of Human Resource in Pharmaceutical field in absence of Education Regulations and central Pharmacy Act; necessity of the involvement of qualified Pharmacists in Pharmacovigilance and other activities related to quality control and rational use of medicines. Draft does not lay out the modalities for establishment of Drug Information Centres and the qualifications of personnel to be engaged for this purpose since it is very important as to who will provide drug information to the medical and non-medical staff and how. It has not been specified as to where Pharmacovigilance centres will be established because there is need to establish such centres in every large hospital of the state. Therefore it will be in the larger interests of patients of this state if these issues are adequately and appropriately addressed in the proposed drug policy of the state govt.
Thursday, December 16, 2010
Thursday, December 9, 2010
Magnitude of Spurious Drug Trade in India
There are several conflicting yet alarming reports about the extent of spurious medicines in Indian markets ranging from as low as 0.25%, as per govt. claims to a whopping 35% as claimed by several independent groups like ASSOCHAM, CII, OECD, EC etc. As per WHO reports spurious drugs now represent 10-12% of $735 billion global market of medicines. Sales of counterfeit drugs worldwide are estimated at $32 billion, causing $46 billion annual loss to the global pharmaceutical industry, recent reports have said. The New York based Centre for Medicines in the Public Interest has predicted that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005. Thus the problem of spurious drugs is reported to be a global phenomenon and India is no exception. India’s pharmaceutical companies have suggested that in Indian major cities, one in five medicines sold is a fake. They have claimed a loss in revenue of between 4% and 5% annually. The industry also estimated that illegal drugs had grown from 10% to 20% of the total market.
According to industry claims, 30 per cent of the Rs 22,000 crore pharma market in India is constituted by spurious products, which translates to an over Rs six-crore trade. About 40% of drug products tested for quality in Nigeria and found to be outside the British Pharmacopoeia limits for drug assay were actually manufactured in India. ASSOCHAM estimates that the lethal market is growing at 25% annually. In fact, the Organization for Economic Cooperation and Development's latest figures say 75% of fake drugs supplied the world over have their origins in India. A recent report by the European Commission said that India is the biggest source of counterfeit drugs in the world, followed by the United Arab Emirates, China and Switzerland. Together, these countries are responsible for more than 80% of all counterfeit medicines, the report said. The GOI, health ministry’s estimates are more conservative though: It says 5% of drugs in India are counterfeit while 0.3% are spurious. Based on the samples tested by the State drug testing authorities in India, for the period 1995-2003. the extent of sub-standard drugs varied from 8.19 to 10.64% and of spurious drugs varied between 0.24 % to 0.47%.
Even as the Health Ministry in India had not yet flagged off its ambitious study to ascertain the extent of spurious drugs in India, details of a recent WHO-sponsored study showed that only 0.3 per cent of samples were found spurious in lab tests, though over 3.1 per cent were found to be counterfeits during visual inspections. The study, held by SEARPharm Forum (South East Asian FIP-WHO Forum of Pharmaceutical Association) in collaboration with Delhi Pharmaceutical Trust, reported that the anti-infective category and those drugs priced below Rs 20 were most prone to counterfeiting. During visual inspection, the extent of counterfeit suspects was to the tune of 3.1 per cent. This was assumed due to striking registration differences in the packing. Based on the domestic sales of Rs. 31,500 crore (7 billion USD) in 2006, the extent of suspected counterfeit medicines would be extrapolated to approximately to Rs. 1000 crore (USD 250 million). These figures are considerably lower than Rs. 4000 crore (USD 1000 million) in earlier reports.
The data showed the Bihar has the highest probability of spurious suspects, with 5.65per cent of samples turning spurious. On a region basis, Central region had more counterfeit suspects. The extent of prevalence was 4.21 per cent while the West had 4per cent, East 3.2 per cent, North 3 per cent and South with 2.8 per cent. Sale of fake and spurious drugs in the NCR region to the extent of Rs.300 crore annually continues to be unabated as, according to the latest ASSOCHAM survey, it has gone upto 20-25% of the total medicines sold in the region. The concentration of fake drugs manufacturers can largely be found out in locations such as Bahadurgarh, Ghaziabad, Aligarh, Bhiwadi, Ballabhgarh, Sonepat, Hisar and Punjab. The analysis of suspected samples showed that even from the states perceived to be strongly regulated, the percentage of counterfeit suspects is almost same as weakly regulated. Confederation of Indian Industries (CII) has concluded that spurious drugs cause a revenue loss of over Rs. 4000 crore to the Indian Pharmaceutical Industry. They have further asserted that in 2001, out of a total production of Rs. 22, 887 crores, 18 % was spurious amounting to Rs. 4112 crores. They have revealed that a majority of medicines supplied under government orders fail necessary quality control tests.
Ex-Union minister for health and family welfare Anbumani Ramadoss is reported to have said in the Lok Sabha that the government of India has never conducted any study to find out the actual extent of spurious medicines in Indian markets. However, two pilot exercises have evaluated the extent of counterfeit drugs in India, one by the office of deputy drugs controller (DDC), Western Zone, and the other by an independent forum known as SEARPharm. A total of 3,246 samples were drawn in the combined exercise. The results of the samples tested revealed only five drugs as counterfeit and two samples not complying to the standards,Ramadoss said. The drive undertaken in two months by the western zone office of the Central Drug Standard Control Organisation (CDSCO) which tested 800 samples from various parts of the region, could find only one counterfeit drug, while it detected no spurious ones. This has been claimed by ex-Deputy Drugs Controller of India (West Zone) Dr. Venkateswarlu, who later on assumed charge as the Drugs Controller General of India. Samples in this study were collected from rural areas in Madhya Pradesh and Orissa. According to the Maharashtra Food and Drug Administration, spurious drug trade is only one per cent of the total marketed formulations in the state.
To ascertain the extent of counterfeit drugs produced in India, the government of India launched a pan-India survey a couple of years back. The move was expected to help the health ministry to collect an authentic data on the problem of fake medicines before taking action against the culprits. The ministry had initially aimed at collecting 3-4 lakh samples during the survey in which the volunteers were expected to pick drug samples from the medical stores even in remote places. However only 24780 samples were collected from across India during November-December, 2008. The drug samples were then sent to drug makers (who have procured the license to produce the packs) for verification, while the doubtful packs were sent for further investigation. In 2009, Union Ministry of Health and Family Welfare made the report of this survey public through Central Drug Standards Control Organization (CDSCO). Survey report revealed that the extent of spurious drugs in retail pharmacy is much below the projections made by various media, WHO, SEARO, and other studies i.e. only 0.046 %. Only 11 samples out of a total of 24,136 samples collected were found to be spurious and the extent of substandard drugs among the branded items is only 0.1 %. Out of a total of 2976 unsuspected samples, only 03 samples did not conform to claim with respect to Assay on chemical analysis.
In this survey a total of 24,780 samples were collected by visiting around 40,000 pharmacy outlets. Samples of popular brands of oral solid dosage (OSD) formulations, belonging to 9 therapeutic categories of anti-infective, anti-malarial, anti-T.B.Drugs, steroids, antihistaminic, cardiovascular drugs, anti-diabetics, NSAIDs, and multivitamin preparations, were collected between November & December 2008 from all across the country. It is not clear from the survey report published by the Central Drug Standards Control Organization (CDSCO) in 2009 as to how many samples were collected from the state of Jammu and Kashmir and which all districts of the state were included in the survey, though it is mentioned that a total of 5665 samples were collected from the entire North Zone including the state of J&K.
With most of the fake drug manufacturing units being based in neighbouring Punjab, Haryana and U.P, Jammu and Kashmir for its proximity to these states has been receiving a fair share of the drugs and medicines manufactured there. In the absence of any robust studies for estimating the magnitude of spurious drug trade on scientific lines in the state it is difficult to hazard a guess on the exact percentage of counterfeit medicines in the state and on the exact impact of such drugs on the health of people at large. There is need to conduct a comprehensive statewide survey on spurious drug trade wherein large number of samples need to be picked from every nook and corner of the state to arrive at a firm conclusion about the extent of the problem prevalent in our state. Further remedial measures suggested by the World Health Organization, IMPACT group, USFDA and Mashelkar Committee like Rapid Alert System (RAS) and Radiofrequency Identification Technique (RFID) need to be implemented in toto to put an early end to the problem.
At present drug inspectorate staff of this state have to spend most of their time in courts pleading for various prosecutions launched by them and are left with very little time to conduct probe against spurious drug rackets operating in their jurisdiction areas. There is urgent need to create separate intelligence and legal cells in the state as well as central offices with adequate provisions of secret funds and incentives for informers. In addition special courts need to be designated to exclusively try the cases of spurious drugs. Severe and deterrent punishments as afforded under law should be imposed on persons dealing with spurious drugs. Exemplary penalties need to be awarded to those found guilty of perpetrating such a heinous crime against humanity.
According to industry claims, 30 per cent of the Rs 22,000 crore pharma market in India is constituted by spurious products, which translates to an over Rs six-crore trade. About 40% of drug products tested for quality in Nigeria and found to be outside the British Pharmacopoeia limits for drug assay were actually manufactured in India. ASSOCHAM estimates that the lethal market is growing at 25% annually. In fact, the Organization for Economic Cooperation and Development's latest figures say 75% of fake drugs supplied the world over have their origins in India. A recent report by the European Commission said that India is the biggest source of counterfeit drugs in the world, followed by the United Arab Emirates, China and Switzerland. Together, these countries are responsible for more than 80% of all counterfeit medicines, the report said. The GOI, health ministry’s estimates are more conservative though: It says 5% of drugs in India are counterfeit while 0.3% are spurious. Based on the samples tested by the State drug testing authorities in India, for the period 1995-2003. the extent of sub-standard drugs varied from 8.19 to 10.64% and of spurious drugs varied between 0.24 % to 0.47%.
Even as the Health Ministry in India had not yet flagged off its ambitious study to ascertain the extent of spurious drugs in India, details of a recent WHO-sponsored study showed that only 0.3 per cent of samples were found spurious in lab tests, though over 3.1 per cent were found to be counterfeits during visual inspections. The study, held by SEARPharm Forum (South East Asian FIP-WHO Forum of Pharmaceutical Association) in collaboration with Delhi Pharmaceutical Trust, reported that the anti-infective category and those drugs priced below Rs 20 were most prone to counterfeiting. During visual inspection, the extent of counterfeit suspects was to the tune of 3.1 per cent. This was assumed due to striking registration differences in the packing. Based on the domestic sales of Rs. 31,500 crore (7 billion USD) in 2006, the extent of suspected counterfeit medicines would be extrapolated to approximately to Rs. 1000 crore (USD 250 million). These figures are considerably lower than Rs. 4000 crore (USD 1000 million) in earlier reports.
The data showed the Bihar has the highest probability of spurious suspects, with 5.65per cent of samples turning spurious. On a region basis, Central region had more counterfeit suspects. The extent of prevalence was 4.21 per cent while the West had 4per cent, East 3.2 per cent, North 3 per cent and South with 2.8 per cent. Sale of fake and spurious drugs in the NCR region to the extent of Rs.300 crore annually continues to be unabated as, according to the latest ASSOCHAM survey, it has gone upto 20-25% of the total medicines sold in the region. The concentration of fake drugs manufacturers can largely be found out in locations such as Bahadurgarh, Ghaziabad, Aligarh, Bhiwadi, Ballabhgarh, Sonepat, Hisar and Punjab. The analysis of suspected samples showed that even from the states perceived to be strongly regulated, the percentage of counterfeit suspects is almost same as weakly regulated. Confederation of Indian Industries (CII) has concluded that spurious drugs cause a revenue loss of over Rs. 4000 crore to the Indian Pharmaceutical Industry. They have further asserted that in 2001, out of a total production of Rs. 22, 887 crores, 18 % was spurious amounting to Rs. 4112 crores. They have revealed that a majority of medicines supplied under government orders fail necessary quality control tests.
Ex-Union minister for health and family welfare Anbumani Ramadoss is reported to have said in the Lok Sabha that the government of India has never conducted any study to find out the actual extent of spurious medicines in Indian markets. However, two pilot exercises have evaluated the extent of counterfeit drugs in India, one by the office of deputy drugs controller (DDC), Western Zone, and the other by an independent forum known as SEARPharm. A total of 3,246 samples were drawn in the combined exercise. The results of the samples tested revealed only five drugs as counterfeit and two samples not complying to the standards,Ramadoss said. The drive undertaken in two months by the western zone office of the Central Drug Standard Control Organisation (CDSCO) which tested 800 samples from various parts of the region, could find only one counterfeit drug, while it detected no spurious ones. This has been claimed by ex-Deputy Drugs Controller of India (West Zone) Dr. Venkateswarlu, who later on assumed charge as the Drugs Controller General of India. Samples in this study were collected from rural areas in Madhya Pradesh and Orissa. According to the Maharashtra Food and Drug Administration, spurious drug trade is only one per cent of the total marketed formulations in the state.
To ascertain the extent of counterfeit drugs produced in India, the government of India launched a pan-India survey a couple of years back. The move was expected to help the health ministry to collect an authentic data on the problem of fake medicines before taking action against the culprits. The ministry had initially aimed at collecting 3-4 lakh samples during the survey in which the volunteers were expected to pick drug samples from the medical stores even in remote places. However only 24780 samples were collected from across India during November-December, 2008. The drug samples were then sent to drug makers (who have procured the license to produce the packs) for verification, while the doubtful packs were sent for further investigation. In 2009, Union Ministry of Health and Family Welfare made the report of this survey public through Central Drug Standards Control Organization (CDSCO). Survey report revealed that the extent of spurious drugs in retail pharmacy is much below the projections made by various media, WHO, SEARO, and other studies i.e. only 0.046 %. Only 11 samples out of a total of 24,136 samples collected were found to be spurious and the extent of substandard drugs among the branded items is only 0.1 %. Out of a total of 2976 unsuspected samples, only 03 samples did not conform to claim with respect to Assay on chemical analysis.
In this survey a total of 24,780 samples were collected by visiting around 40,000 pharmacy outlets. Samples of popular brands of oral solid dosage (OSD) formulations, belonging to 9 therapeutic categories of anti-infective, anti-malarial, anti-T.B.Drugs, steroids, antihistaminic, cardiovascular drugs, anti-diabetics, NSAIDs, and multivitamin preparations, were collected between November & December 2008 from all across the country. It is not clear from the survey report published by the Central Drug Standards Control Organization (CDSCO) in 2009 as to how many samples were collected from the state of Jammu and Kashmir and which all districts of the state were included in the survey, though it is mentioned that a total of 5665 samples were collected from the entire North Zone including the state of J&K.
With most of the fake drug manufacturing units being based in neighbouring Punjab, Haryana and U.P, Jammu and Kashmir for its proximity to these states has been receiving a fair share of the drugs and medicines manufactured there. In the absence of any robust studies for estimating the magnitude of spurious drug trade on scientific lines in the state it is difficult to hazard a guess on the exact percentage of counterfeit medicines in the state and on the exact impact of such drugs on the health of people at large. There is need to conduct a comprehensive statewide survey on spurious drug trade wherein large number of samples need to be picked from every nook and corner of the state to arrive at a firm conclusion about the extent of the problem prevalent in our state. Further remedial measures suggested by the World Health Organization, IMPACT group, USFDA and Mashelkar Committee like Rapid Alert System (RAS) and Radiofrequency Identification Technique (RFID) need to be implemented in toto to put an early end to the problem.
At present drug inspectorate staff of this state have to spend most of their time in courts pleading for various prosecutions launched by them and are left with very little time to conduct probe against spurious drug rackets operating in their jurisdiction areas. There is urgent need to create separate intelligence and legal cells in the state as well as central offices with adequate provisions of secret funds and incentives for informers. In addition special courts need to be designated to exclusively try the cases of spurious drugs. Severe and deterrent punishments as afforded under law should be imposed on persons dealing with spurious drugs. Exemplary penalties need to be awarded to those found guilty of perpetrating such a heinous crime against humanity.
Sunday, September 12, 2010
Mushroom growth of medical stores across the state - reasons and solutions
Mushroom growth of drug stores along the length and breadth of J&K state including both licensed and unlicensed premises has lately become a matter of great concern for all. Earlier on the problem of unlicensed medical stores was more prevalent but now the problem of innumerable licensed premises is assuming alarming proportions due to the fact that a majority of them are being managed by people who are not even remotely connected to the profession of pharmacy. Few years back when our state was faced with the menace of flourishing trade of unlicensed medical stores, it was only after the intervention of J&K High Court against a public interest litigation that some action was palpable on ground and quite a few of such stores were shuttered down but only to pave way for more organized yet dangerous trade perpetrated in a more legalized fashion. Those running illegal shops earlier were issued with registration certificates by the J&K Pharmacy Council on the basis of their experience in drug trade and subsequently on grounds of this registration, licenses were issued to them in a very clandestine and surreptitious manner, without taking any cognizance of whether they had the adequate professional qualification or not and unfortunately such registration process continues unabated even today. Now the question is whether the whole process is legally just or not.
To explain this we need to flash back to late ninetees when we neither had a state branch of the Pharmacy Council of India nor did we have our own independent Pharmacy Council; courtesy inaction and lackadaisical attitude of our local administrators. State unit of PCI could not be formed so far due to non-extension of the central Pharmacy Act of 1948 to the state of J&K; courtesy Article 370 of the Indian constitution. Therefore our state instead of extending the jurisdiction of central Pharmacy Act to the state chose to constitute its own J&K Pharmacy Council under the auspices of its own J&K Pharmacy Act 2012 (Samvat). Composition of this council instead of being broad-based and all inclusive was narrowly confined to the Drug and Food Control Organization of J&K with some representation being given to the J&K Druggists and Chemists Association. No professionals from academia, hospitals or industry were included in the newly constituted council which exists in the same format till date for more than a decade now. Its term expired and was renewed every time without much change in its composition. Needless to say that a wider participation of the pharmacy professionals drawn from various sections like academia, clinical set up, regulatory affairs, industry as well as sales and marketing in the affairs of the J&K Pharmacy Council could have paved way for its better functioning, improved outcome and greater acceptance of its policies. Its working should not have been confined to any one department of the state administration. Since its decisions affect the entire profession, it calls for a broader representation to all concerned as is true with state pharmacy councils of any other state of the Union of India.
When the issue of unlicensed medical stores alongwith other healthcare related issues rocked the J&K High Court few years back, Drug Control officials were woken up from deep slumber and were forced to take action even though half-heartedly against the defaulters. Subsequently J&K Pharmacy Council issued notification for subsequent registration which is a mandatory procedure to be followed by the J&K Pharmacy Council as per the statues laid down in the J&K Pharmacy Act, after it is done with first registration. First registration was carried out soon after the formation of J&K Pharmacy Council whereunder all the qualified people engaged in the profession or trade of pharmacy at that time were registered as Pharmacists in the First Register prepared by the council. Subsequent registration was to come to a halt soon after the process of registering any new professionals would have been over. But unfortunately process never came to a halt and is continuing till date without any signs of closure.
One may ask what is the problem if people are registered by the J&K Pharmacy Council on the basis of their experience in drug trade and then issued with licenses to run their medical stores. The problem is only one that they are not qualified as per the established norms. At present anybody wishing to plunge into medical business just has to manage an experience certificate from any licensed drug store, approach the Pharmacy Council for registration as a Pharmacist and he will earn the title of a Pharmacist irrespective of whether he was earlier carrying on the business of a barber, a mason, a vegetable vendor or a minibus driver. That is because anybody can issue an experience certificate to anyone else on the basis of his personal rapport or relations, vested interests or monetary gains and thus render the whole exercise terribly defective and that is exactly what has been happening.
The Jammu and Kashmir Pharmacy Council constituted more than a decade back, after preparing its first and subsequent register of those pharmacists who have been carrying on the business or profession of pharmacy in J&K, has to frame an Executive Committee and regulate pharmacy education in the state by way of enforcement of Education Regulations as provided under section 10 of the J&K Pharmacy Act 2011 (samvat). Thereunder it has to prescribe the minimum standards of education required for qualification as a pharmacist and also prescribe the nature and period of study and of practical training to be undertaken before admission to the qualifying examination for a degree or diploma in pharmacy. Further these regulations shall also lay down the subjects of examination and the standards to be attained therein apart from the equipment and facilities to be provided to students for undergoing such approved courses of study. Once Education Regulations are framed entry of unqualified and unscrupulous people into the profession of pharmacy will be barred and no person other than a diploma or a degree holder in pharmacy would be designated or registered as a pharmacist and a target date would be fixed beyond which no person other than a pharmacy degree or diploma holder could apply for a drug sale license either. Drug trade would thereafter be strictly restricted to diploma or degree holders in pharmacy only and this will go a long way in ensuring that drugs are dispensed and distributed among patients only by qualified and deserving professionals. In fact in other parts of the country majority of states are in the process of abolishing even diploma course in pharmacy and making degree in pharmacy as the minimum mandatory qualification for registration as a pharmacist. Yet unfortunately we in our state are still registering all and sundry irrespective of their qualification, expertise and know-how as pharmacists.
Just the way central Drugs and Cosmetics Act, 1940 has been enforced in the state, central Pharmacy Act of 1948 too needs to be promulgated in place of J&K Pharmacy Act 2011 (samvat). This will bring all pharmacy academic institutions of the state under the purview of the Pharmacy Council of India, help our pharmacists get registered in the Central Register and practice pharmacy profession anywhere in India. Besides it will also enable our pharmacy institutions seek financial assistance from central councils, organize and participate in their continuing education programmes, seminars etc and achieve national and international level standards in our pharmacy and health education. After constituting its Executive Committee and enforcing Education Regulations in the state, J&K Pharmacy Council can also appoint its own inspectors having prescribed qualifications, as provided under section 26 A of the Pharmacy Act, 1948 in order to inspect the premises where drugs are dispensed, to enquire whether a person who is engaged in selling, dispensing or compounding of drugs is a registered pharmacist, to investigate complaints regarding contravention of the Act and to institute prosecutions against the offenders. This initiative shall help our society get rid of drug delivery and distribution at the hands of unqualified, unregistered and unscrupulous people.
All said and done, damage has already been caused to the pharmacy profession in the state. A sea of unqualified people already stand designated with the title of a pharmacist and it is next to impossible to undo that damage. Least we could do is to prevent anymore destruction and dilution of this profession by putting brakes in right earnest on the registration process, by framing and implementing Education Regulations and by making degree or diploma in pharmacy as the minimum qualification for registration as a pharmacist. Further scope of the J&K Pharmacy Council needs to be widened and it needs to be made broad-based giving due representation to all stake-holders including drug control officials, pharmacists from hospitals, experts from pharmaceutical industry, pharmacy academicians and drug analysts. Otherwise the clandestine and irrational practices of the existing pharmacy council shall carry on unabated.
To explain this we need to flash back to late ninetees when we neither had a state branch of the Pharmacy Council of India nor did we have our own independent Pharmacy Council; courtesy inaction and lackadaisical attitude of our local administrators. State unit of PCI could not be formed so far due to non-extension of the central Pharmacy Act of 1948 to the state of J&K; courtesy Article 370 of the Indian constitution. Therefore our state instead of extending the jurisdiction of central Pharmacy Act to the state chose to constitute its own J&K Pharmacy Council under the auspices of its own J&K Pharmacy Act 2012 (Samvat). Composition of this council instead of being broad-based and all inclusive was narrowly confined to the Drug and Food Control Organization of J&K with some representation being given to the J&K Druggists and Chemists Association. No professionals from academia, hospitals or industry were included in the newly constituted council which exists in the same format till date for more than a decade now. Its term expired and was renewed every time without much change in its composition. Needless to say that a wider participation of the pharmacy professionals drawn from various sections like academia, clinical set up, regulatory affairs, industry as well as sales and marketing in the affairs of the J&K Pharmacy Council could have paved way for its better functioning, improved outcome and greater acceptance of its policies. Its working should not have been confined to any one department of the state administration. Since its decisions affect the entire profession, it calls for a broader representation to all concerned as is true with state pharmacy councils of any other state of the Union of India.
When the issue of unlicensed medical stores alongwith other healthcare related issues rocked the J&K High Court few years back, Drug Control officials were woken up from deep slumber and were forced to take action even though half-heartedly against the defaulters. Subsequently J&K Pharmacy Council issued notification for subsequent registration which is a mandatory procedure to be followed by the J&K Pharmacy Council as per the statues laid down in the J&K Pharmacy Act, after it is done with first registration. First registration was carried out soon after the formation of J&K Pharmacy Council whereunder all the qualified people engaged in the profession or trade of pharmacy at that time were registered as Pharmacists in the First Register prepared by the council. Subsequent registration was to come to a halt soon after the process of registering any new professionals would have been over. But unfortunately process never came to a halt and is continuing till date without any signs of closure.
One may ask what is the problem if people are registered by the J&K Pharmacy Council on the basis of their experience in drug trade and then issued with licenses to run their medical stores. The problem is only one that they are not qualified as per the established norms. At present anybody wishing to plunge into medical business just has to manage an experience certificate from any licensed drug store, approach the Pharmacy Council for registration as a Pharmacist and he will earn the title of a Pharmacist irrespective of whether he was earlier carrying on the business of a barber, a mason, a vegetable vendor or a minibus driver. That is because anybody can issue an experience certificate to anyone else on the basis of his personal rapport or relations, vested interests or monetary gains and thus render the whole exercise terribly defective and that is exactly what has been happening.
The Jammu and Kashmir Pharmacy Council constituted more than a decade back, after preparing its first and subsequent register of those pharmacists who have been carrying on the business or profession of pharmacy in J&K, has to frame an Executive Committee and regulate pharmacy education in the state by way of enforcement of Education Regulations as provided under section 10 of the J&K Pharmacy Act 2011 (samvat). Thereunder it has to prescribe the minimum standards of education required for qualification as a pharmacist and also prescribe the nature and period of study and of practical training to be undertaken before admission to the qualifying examination for a degree or diploma in pharmacy. Further these regulations shall also lay down the subjects of examination and the standards to be attained therein apart from the equipment and facilities to be provided to students for undergoing such approved courses of study. Once Education Regulations are framed entry of unqualified and unscrupulous people into the profession of pharmacy will be barred and no person other than a diploma or a degree holder in pharmacy would be designated or registered as a pharmacist and a target date would be fixed beyond which no person other than a pharmacy degree or diploma holder could apply for a drug sale license either. Drug trade would thereafter be strictly restricted to diploma or degree holders in pharmacy only and this will go a long way in ensuring that drugs are dispensed and distributed among patients only by qualified and deserving professionals. In fact in other parts of the country majority of states are in the process of abolishing even diploma course in pharmacy and making degree in pharmacy as the minimum mandatory qualification for registration as a pharmacist. Yet unfortunately we in our state are still registering all and sundry irrespective of their qualification, expertise and know-how as pharmacists.
Just the way central Drugs and Cosmetics Act, 1940 has been enforced in the state, central Pharmacy Act of 1948 too needs to be promulgated in place of J&K Pharmacy Act 2011 (samvat). This will bring all pharmacy academic institutions of the state under the purview of the Pharmacy Council of India, help our pharmacists get registered in the Central Register and practice pharmacy profession anywhere in India. Besides it will also enable our pharmacy institutions seek financial assistance from central councils, organize and participate in their continuing education programmes, seminars etc and achieve national and international level standards in our pharmacy and health education. After constituting its Executive Committee and enforcing Education Regulations in the state, J&K Pharmacy Council can also appoint its own inspectors having prescribed qualifications, as provided under section 26 A of the Pharmacy Act, 1948 in order to inspect the premises where drugs are dispensed, to enquire whether a person who is engaged in selling, dispensing or compounding of drugs is a registered pharmacist, to investigate complaints regarding contravention of the Act and to institute prosecutions against the offenders. This initiative shall help our society get rid of drug delivery and distribution at the hands of unqualified, unregistered and unscrupulous people.
All said and done, damage has already been caused to the pharmacy profession in the state. A sea of unqualified people already stand designated with the title of a pharmacist and it is next to impossible to undo that damage. Least we could do is to prevent anymore destruction and dilution of this profession by putting brakes in right earnest on the registration process, by framing and implementing Education Regulations and by making degree or diploma in pharmacy as the minimum qualification for registration as a pharmacist. Further scope of the J&K Pharmacy Council needs to be widened and it needs to be made broad-based giving due representation to all stake-holders including drug control officials, pharmacists from hospitals, experts from pharmaceutical industry, pharmacy academicians and drug analysts. Otherwise the clandestine and irrational practices of the existing pharmacy council shall carry on unabated.
Revive drug control administration of the state
The multiplicity of drugs, the increased number and kinds of medications prescribed per patient, the increased number of both in-patients and out-patients who are being treated and the ever changing concepts of medical care make it mandatory that a system of safe medication practices be developed and maintained to ensure that the patients receive the best possible treatment, care and protection. Drug inspectors are the only personnel legally empowered to enforce various provisions of the Drugs and Cosmetics Act. We should have them in adequate numbers so that they share a manageable jurisdiction and workload.
To reinforce and ensure effective control over the quality and efficacy of drugs as well their sale in accordance with set norms, drug control enforcement staff needs to be augmented and strengthened in tune with the orders of Supreme Court of India and the recommendations of several committees like Hathi Committee report (1975), National Human Rights Commission Report (1999) and the report of Parliamentary Standing Committee on Petroleum and Chemicals (2001). The Mashelkar Committee on Pharmaceutical Research and Development (2002) has also recommended the establishment of a first class Drug Regulatory infrastructure in every state. There has to be at least one drug inspector designated for every 100 sales outlets or 25 manufacturing establishments. Accordingly there should be one drug inspector available at every block level in the state. In light of the fact that there are only 103 medical blocks in the entire state, net financial implication of this augmentation is estimated to be not more than rupees 1.25 crore per annum. This much financial burden on the state exchequer should be quite bearable in the face of its potential benefits in terms of an effective drug control mechanism in the state. In this direction, there has been a breakthrough in that a detailed proposal framed by this author on behalf of the J&K Pharmacy Graduates Association towards creation of 90 posts of Drug Inspectors and their subsequent placement at medical Block level in the state, after having been duly endorsed by the Drugs Controller of the J&K state has been finally accepted by the Ministry of Health and Family Welfare, J&K Government that has issued directions vide Government Order No. 604-HME of 2007 dated 10.09.2007 towards creation of 72 posts of Drug Inspectors (though not at Block level) in the state. However inordinate delay is being caused in the prompt advertisement and subsequent recruitment against these posts that is posing hurdles in effective enforcement of the provisions of various drug legislations like Drugs and Cosmetics Act etc in the state.
Presently drugs falling under alternative systems of medicine including Ayurveda, Unani, Siddha and Homeopathy are not regulated by any legal framework so far as their sale, storage or distribution is concerned. Though provisions relating to these aspects have been outlined in the Drugs and Cosmetics Act, 1940 and Rules thereunder, these provisions have not been enforced unlike other provisions relating to the drugs belonging to the allopathic system of medicine. Therefore it should be a priority for the state govt. to bring drug sale, storage and distribution of alternative systems of medicine also under the ambit of Drug and Food Control Administration and adequate powers should be vested upon the existing staff in this regard until further augmentation is made possible. Further the provisions of Drugs and Cosmetics Act, 1940 dealing with the manufacture, sale, storage and distribution of cosmetics may also be enforced to the possible extent in due course of time. This shall in turn further strengthen the need for expansion of manpower presently available with the Drug and Food Control Organization, J&K. Further adequate transportation, accommodation, communication and judicial assistance facilities to the available inspectorate staff are extremely vital for proper enforcement and efficient monitoring of drug regulatory legislations within the state and hence need immediate attention to the maximum possible extent. It is therefore time to revive, revamp and reconstruct our drug control administration on the pattern of states like FDA, Maharashtra so as to make drugs of best quality, safety and efficacy available to the masses at reasonable rates along with suitable counseling services by qualified pharmacists at drug distribution outlets.
As the number of brands available in the market keep soaring, the issue of quality will assume permanent importance. Across the globe, countries are adopting rigorous drugs quality control systems and enforcement mechanisms to avoid sub-standard/spurious drugs in their respective markets. Adequate and up-to-date drug testing facilities are essential for an exact estimation of frequency and prevalence of spurious drugs in the market. As such, there is a need for an urgent augmentation of the drug testing facilities in our state in respect of equipment, technical staff and infrastructure. Modernization and up-gradation of the two existing drug testing laboratories at Jammu and Srinagar should be taken up at war footing basis. Third generation testing equipments like HPLC, HPTLC, GC/MS, FTIR, NMR and UV-Spectrophotometry need to be introduced in a phased manner. Continuing education programmes, training workshops etc will have to be conducted for training the existing technical staff in handling such instruments. Further, govt. should also consider setting up of an additional, state-of-the-art, modern and fully equipped drug testing laboratory under the auspices of Central Drug Standards Control Organization (CDSCO), Ghaziabad or in association with Union Ministry of Health and Family Welfare. Moreover an ever-increasing need for more extensive testing and analysis of drugs and pharmaceuticals demand more number of posts of Govt. Analysts and other skilled technical personnel for such analysis. Annual testing load and average testing time of each laboratory should be streamlined and fixed in line with the available facilities. Both testing laboratories should be sophisticated to the extent of making them able to test all kinds of drugs including parenterals. At present, most of the parenteral products are sent to CIPL, Ghaziabad as the necessary facilities are not available here thus causing inordinate delay in initiating legal proceedings against the defaulters. Quality control cells will have to be constituted in every major hospital as part of in-house Quality Assurance system.
Drug inspectorate staff of this state have to spend most of their time in courts pleading for various prosecutions launched by them and are left with very little time to conduct probe against spurious drug rackets operating in their jurisdiction areas. There is urgent need to create separate intelligence and legal cells in the state as well as central offices with adequate provisions of secret funds and incentives for informers. In addition special courts need to be designated to exclusively try the cases of spurious drugs. Severe and deterrent punishments as afforded under law should be imposed on persons dealing with spurious drugs. Several countries across the globe have introduced death penalty for the persons involved in spurious drug trade. Such kind of exemplary penalties need to be awarded to those found guilty of perpetrating such a heinous crime against humanity. Moreover there has not been a comprehensive review of the Drugs & Cosmetics Act 1940 since its enactment, although Rules have been amended from time to time to keep them up to date and there is also an ever growing concern regarding the problem of spurious drugs. It is important to see all the issues in an integrated manner.
To reinforce and ensure effective control over the quality and efficacy of drugs as well their sale in accordance with set norms, drug control enforcement staff needs to be augmented and strengthened in tune with the orders of Supreme Court of India and the recommendations of several committees like Hathi Committee report (1975), National Human Rights Commission Report (1999) and the report of Parliamentary Standing Committee on Petroleum and Chemicals (2001). The Mashelkar Committee on Pharmaceutical Research and Development (2002) has also recommended the establishment of a first class Drug Regulatory infrastructure in every state. There has to be at least one drug inspector designated for every 100 sales outlets or 25 manufacturing establishments. Accordingly there should be one drug inspector available at every block level in the state. In light of the fact that there are only 103 medical blocks in the entire state, net financial implication of this augmentation is estimated to be not more than rupees 1.25 crore per annum. This much financial burden on the state exchequer should be quite bearable in the face of its potential benefits in terms of an effective drug control mechanism in the state. In this direction, there has been a breakthrough in that a detailed proposal framed by this author on behalf of the J&K Pharmacy Graduates Association towards creation of 90 posts of Drug Inspectors and their subsequent placement at medical Block level in the state, after having been duly endorsed by the Drugs Controller of the J&K state has been finally accepted by the Ministry of Health and Family Welfare, J&K Government that has issued directions vide Government Order No. 604-HME of 2007 dated 10.09.2007 towards creation of 72 posts of Drug Inspectors (though not at Block level) in the state. However inordinate delay is being caused in the prompt advertisement and subsequent recruitment against these posts that is posing hurdles in effective enforcement of the provisions of various drug legislations like Drugs and Cosmetics Act etc in the state.
Presently drugs falling under alternative systems of medicine including Ayurveda, Unani, Siddha and Homeopathy are not regulated by any legal framework so far as their sale, storage or distribution is concerned. Though provisions relating to these aspects have been outlined in the Drugs and Cosmetics Act, 1940 and Rules thereunder, these provisions have not been enforced unlike other provisions relating to the drugs belonging to the allopathic system of medicine. Therefore it should be a priority for the state govt. to bring drug sale, storage and distribution of alternative systems of medicine also under the ambit of Drug and Food Control Administration and adequate powers should be vested upon the existing staff in this regard until further augmentation is made possible. Further the provisions of Drugs and Cosmetics Act, 1940 dealing with the manufacture, sale, storage and distribution of cosmetics may also be enforced to the possible extent in due course of time. This shall in turn further strengthen the need for expansion of manpower presently available with the Drug and Food Control Organization, J&K. Further adequate transportation, accommodation, communication and judicial assistance facilities to the available inspectorate staff are extremely vital for proper enforcement and efficient monitoring of drug regulatory legislations within the state and hence need immediate attention to the maximum possible extent. It is therefore time to revive, revamp and reconstruct our drug control administration on the pattern of states like FDA, Maharashtra so as to make drugs of best quality, safety and efficacy available to the masses at reasonable rates along with suitable counseling services by qualified pharmacists at drug distribution outlets.
As the number of brands available in the market keep soaring, the issue of quality will assume permanent importance. Across the globe, countries are adopting rigorous drugs quality control systems and enforcement mechanisms to avoid sub-standard/spurious drugs in their respective markets. Adequate and up-to-date drug testing facilities are essential for an exact estimation of frequency and prevalence of spurious drugs in the market. As such, there is a need for an urgent augmentation of the drug testing facilities in our state in respect of equipment, technical staff and infrastructure. Modernization and up-gradation of the two existing drug testing laboratories at Jammu and Srinagar should be taken up at war footing basis. Third generation testing equipments like HPLC, HPTLC, GC/MS, FTIR, NMR and UV-Spectrophotometry need to be introduced in a phased manner. Continuing education programmes, training workshops etc will have to be conducted for training the existing technical staff in handling such instruments. Further, govt. should also consider setting up of an additional, state-of-the-art, modern and fully equipped drug testing laboratory under the auspices of Central Drug Standards Control Organization (CDSCO), Ghaziabad or in association with Union Ministry of Health and Family Welfare. Moreover an ever-increasing need for more extensive testing and analysis of drugs and pharmaceuticals demand more number of posts of Govt. Analysts and other skilled technical personnel for such analysis. Annual testing load and average testing time of each laboratory should be streamlined and fixed in line with the available facilities. Both testing laboratories should be sophisticated to the extent of making them able to test all kinds of drugs including parenterals. At present, most of the parenteral products are sent to CIPL, Ghaziabad as the necessary facilities are not available here thus causing inordinate delay in initiating legal proceedings against the defaulters. Quality control cells will have to be constituted in every major hospital as part of in-house Quality Assurance system.
Drug inspectorate staff of this state have to spend most of their time in courts pleading for various prosecutions launched by them and are left with very little time to conduct probe against spurious drug rackets operating in their jurisdiction areas. There is urgent need to create separate intelligence and legal cells in the state as well as central offices with adequate provisions of secret funds and incentives for informers. In addition special courts need to be designated to exclusively try the cases of spurious drugs. Severe and deterrent punishments as afforded under law should be imposed on persons dealing with spurious drugs. Several countries across the globe have introduced death penalty for the persons involved in spurious drug trade. Such kind of exemplary penalties need to be awarded to those found guilty of perpetrating such a heinous crime against humanity. Moreover there has not been a comprehensive review of the Drugs & Cosmetics Act 1940 since its enactment, although Rules have been amended from time to time to keep them up to date and there is also an ever growing concern regarding the problem of spurious drugs. It is important to see all the issues in an integrated manner.
Reforms required in education system of J&K state
1. Address gross academic issues like admissions, syllabi, coordination, faculty strength, teachers training, research etc effectively. Admissions to be made strictly in accordance with the intake capacity of the academic institutions and merit of the aspiring candidates. Syllabi to be updated regularly in tune with changing times and trends. Carry out regular review and reforms of conventional examination and evaluation patterns. A teacher to be evaluated not only for his teaching but also for his research and extension activities. Quality of research work to be drastically improved. Research work to be made more applied and productive.
2. Making more infrastructure, staff, facilities and funds available to colleges and universities. Haphazard and unplanned expansion of higher educational institutes to be halted. Prior to opening up of new colleges, adequate infrastructure, faculty and other facilities to be made available. Diversion of faculty from old to new institutions to be stopped. Adhocism and contractualism to be done away. Sufficient number of fresh posts to be created for newly established institutions.
3. Promulgate a new robust and comprehensive state education policy. Disparities between state and central policies need to be removed. Bridge the gap between academia and policy-makers and frame policies after mutual consultation with academia.
4. Link education with livelihood and make it job-oriented. Professional and vocational education to be fostered and employability to be promoted to alleviate skill-deprivation among students.
5. Stop political interference in academic matters like admissions, appointments, promotions, transfers etc. Recruitment and transfer procedures and policies to be made more transparent and fool-proof.
6. Diversify education by making more subject combinations available right after matriculation. Vertical movement of students to be diversified and made more choice-based at an earlier stage than existing at present.
7. Modify conventional teaching methodologies and introduce recent advances in technology into the teaching-learning process. Switch over from chalk and talk to more interactive mode of teaching and learning by making use of audio-visual aids, e-contents, databases, learning objects etc. Creative skills and competitive spirits of the learners to be encouraged in order to make them accomplished achievers rather than passive knowledge-seekers. Non-scholastic aspects of the learners’ personality to be assessed. Value based education for inculcating ethics and morality among students to be reinforced.
8. Elevate accountability in the system, implement reports and recommendations of various expert committees and statutory bodies like UGC, AICTE, higher education dept. etc. Regular assessment of teachers to be carried out through students. Training and placement of pass-outs to be made an integral part besides conducting refresher courses and QIPs for teachers. Privatization of education to be allowed in a controlled fashion and subject to a strict regulatory mechanism under the aegis of a regulatory authority or higher education council. Partnership to receive thrust over complete privatization. Assessment of all educational institutes by NAAC, NAB etc to be made mandatory and financial support to be provided in accordance with the ranks obtained therein.
9. Augment residential facilities available to students as well as teachers at district, sub-district and block level. Extended library facilities to be made available beyond normal working hours in all degree colleges. Need for greater integration, collaboration and better coordination between primary, secondary, higher secondary and university level education in the state and to have a supervisory council with advisory status for integration of these three units.
10. Academia-industry and academia-society interactions to be enhanced at all levels. Provide greater autonomy to well-established premier degree level colleges, particularly in designing their own curricula, making admissions and conducting examinations/evaluation etc. Distance mode of education to be fostered in view of limited intake capacity in colleges and universities.
2. Making more infrastructure, staff, facilities and funds available to colleges and universities. Haphazard and unplanned expansion of higher educational institutes to be halted. Prior to opening up of new colleges, adequate infrastructure, faculty and other facilities to be made available. Diversion of faculty from old to new institutions to be stopped. Adhocism and contractualism to be done away. Sufficient number of fresh posts to be created for newly established institutions.
3. Promulgate a new robust and comprehensive state education policy. Disparities between state and central policies need to be removed. Bridge the gap between academia and policy-makers and frame policies after mutual consultation with academia.
4. Link education with livelihood and make it job-oriented. Professional and vocational education to be fostered and employability to be promoted to alleviate skill-deprivation among students.
5. Stop political interference in academic matters like admissions, appointments, promotions, transfers etc. Recruitment and transfer procedures and policies to be made more transparent and fool-proof.
6. Diversify education by making more subject combinations available right after matriculation. Vertical movement of students to be diversified and made more choice-based at an earlier stage than existing at present.
7. Modify conventional teaching methodologies and introduce recent advances in technology into the teaching-learning process. Switch over from chalk and talk to more interactive mode of teaching and learning by making use of audio-visual aids, e-contents, databases, learning objects etc. Creative skills and competitive spirits of the learners to be encouraged in order to make them accomplished achievers rather than passive knowledge-seekers. Non-scholastic aspects of the learners’ personality to be assessed. Value based education for inculcating ethics and morality among students to be reinforced.
8. Elevate accountability in the system, implement reports and recommendations of various expert committees and statutory bodies like UGC, AICTE, higher education dept. etc. Regular assessment of teachers to be carried out through students. Training and placement of pass-outs to be made an integral part besides conducting refresher courses and QIPs for teachers. Privatization of education to be allowed in a controlled fashion and subject to a strict regulatory mechanism under the aegis of a regulatory authority or higher education council. Partnership to receive thrust over complete privatization. Assessment of all educational institutes by NAAC, NAB etc to be made mandatory and financial support to be provided in accordance with the ranks obtained therein.
9. Augment residential facilities available to students as well as teachers at district, sub-district and block level. Extended library facilities to be made available beyond normal working hours in all degree colleges. Need for greater integration, collaboration and better coordination between primary, secondary, higher secondary and university level education in the state and to have a supervisory council with advisory status for integration of these three units.
10. Academia-industry and academia-society interactions to be enhanced at all levels. Provide greater autonomy to well-established premier degree level colleges, particularly in designing their own curricula, making admissions and conducting examinations/evaluation etc. Distance mode of education to be fostered in view of limited intake capacity in colleges and universities.
Free medicines for the poor - a dream long cherished
Though India is ranked as fourth worldwide in making drugs, around 26% of its population living below the poverty line (BPL) is still not getting medicines because of their lower economic status. There is very poor accessibility of drugs to this population and even low priced medicines become unaffordable for them. However drugs are not like any other industrial products or consumer goods; availability of affordable medicines can make a difference between life and death for millions of people. One wonders that if right to life is the basic right of all human beings, poor or rich alike, why there are no remedial measures for such hapless people put forth by the government whereby they could get some free medicines to survive. There is not much assistance rendered by the NGOs too on such counts. Despite mushroom growth of NGOs there is hardly one that could exclusively cater to the medical expenditures of poor and downtrodden patients of our society. With new National Pharmaceutical Policy being reviewed by a union ministerial panel before its promulgation and a new National Health Insurance Scheme being launched, a dream of making free medicines available to the poor patients seems to become a reality soon.
National Common Minimum Programme of the present UPA government at center had stipulated that ‘Special attention would be paid to the poorer sections in the matter of health care’. In this direction government of India has proposed to launch a new national health insurance scheme by the name of “Rashtriya Swasthya Bima Yojana” for families living Below Poverty Line (BPL) in its draft National Pharmaceutical Policy 2008 which is likely to be promulgated soon by the Union Ministry of Chemicals and Fertilizers. This Scheme shall be implemented in a phased manner. Initially it would be launched on a pilot basis in two districts of each state. Based on the experience gained therefrom, it would be extended to all families below poverty line throughout the country. Distinguishing feature of the scheme is that the Government of India shall pay full cost of the premium amount for all BPL beneficiaries, who shall be provided benefits on the basis of BPL/Health cards issued to them by the States. Benefit of hospitalization upto Rs. 15000 and for medicines as out-patients upto Rs.5000 per annum per family shall be made available. Scheme shall be implemented by the four public sector insurance companies in the country. Each Insurance company would shortlist chemist shops upto PHC/taluka level. A certain number of BPL families would be assigned to each selected chemist shop.
Chemist shops will maintain complete account of the medicines taken by the BPL persons and send the same to insurance companies from time to time. BPL family can approach any government doctor in the area. Based on the prescription of the government physician the BPL cardholder can approach the authorized chemist shop for obtaining medicines. He would be supplied medicines free of cost. The chemist would send the bill to the concerned insurance company that would reimburse him for the amount of the medicines purchased by the BPL family. The entire insurance premium on account of the BPL families would be paid by the government to the insurance companies. Medicines have to be provided on the basis of prescriptions by government doctors only. From the third year of operation of the scheme it would be suitably revised and extended to all parts of the country. The source of funding for this and other related schemes would be a health cess of 2% to be levied on various central taxes by the government on the analogy of education cess, which is likely to provide approx. Rs 6500 crores to the government. In order to ensure that the money collected from the cess is not diverted to other areas it shall be kept in a separate non-lapsable fund. This fund may be managed by an independent body specially designated for this purpose that may be called the National Public Health Board. In case there is difficulty in levying of health cess, government may provide funds amounting to Rs. 6500 crores which is equivalent to 0.02% of the GDP out of the general budget. Present expenditure on health is only 0.9% of GDP, whereas as per national common minimum programme, it is to be raised to 2 to 3 % of GDP.
Besides the above-mentioned scheme, draft National Pharmaceutical Policy also envisages to set up State/District Illness Assistance Funds (SIAFs) in all states with financial assistance from the central government. Larger allocation would be made by the central government towards already in-force National Illness Assistance Fund (NIAF). Revolving Funds for BPL families would be set up in all the central government hospitals and the states would also be asked to set up revolving funds in all the government hospitals for free treatment of BPL families. Further in order to increase the reach of poor people to these funds District Level Revolving Fund would also be maintained, whose quantum would be Rs. 1.00 crore. Initial amount of Rs. 1.00 crore would be provided by the central government; thereafter it would be shared on 50:50 basis between the centre and the states. The fund would be replenished as soon as the level of fund in a district falls below Rs. 50 lacs. Wide publicity would be given to the availability of funds at the district, state and central levels. Proposed allocation for these schemes is Rs. 1000 crores, that will be mainly generated through the above-mentioned health cess of around 2%. Some states are already making good use of these schemes for the BPL families through NIAF, while most of them have not yet set up the State Illness Assistance Funds.
In-order to increase accessibility of medicines to the BPL families efforts would be made to establish a District Drug Bank at each district level. Considering that there are 600 districts in the country an equal number of drug banks would be set up in a phased manner. These banks could be managed by Red Cross Societies, Medicare Societies or such other charitable bodies having liaison with the district level administration/hospitals. Various pharmaceutical manufacturers would be encouraged to donate generously to these drug banks - efforts would be made that they adopt one or two districts for this purpose. Such drug donations would be made eligible for tax exemption under the corporate tax. Alternately some prominent NGOs may come forward and volunteer setting up of such medicare societies in all the hospitals of the state on the lines of Medicare Relief Societies of Rajasthan that provide cheaper medicines to the common man through outlets known as Lifeline Fluid Stores that are set up within the hospital premises.
All lucrative intricacies of these patient-friendly schemes apart, people at large are quite skeptical about their success in terms of actual transfer of all the benefits to the truly deserving sections of our society, in view of the past performance of other central schemes that have most of the times fallen prey to massive corruption, nepotism and favourtism. However the checks and measures put forth by the government this time seem to be quite promising and one can only hope that the target population of these schemes will be more vigilant and aware of their rights this time so as to take full advantage of these schemes and at the same time implementation and monitoring aspects of these schemes shall be made stringent enough by the govt. so as to prevent any pilferage or misuse by unscrupulous and corrupt elements. The UPA government at the center had vowed in its common minimum programme to launch these schemes soon after coming to power. Now that their implementation has already got delayed so much, govt. should seriously consider reducing the proposed trial period of these schemes from two years to only one year. Further the BPL families should be able to procure free medicines from chosen medical stores throughout the state not merely from the stores of their native areas.
Further in our state though medicines are supplied through two provincial medical stores to almost all hospitals for free distribution among patients, there have been reports of rampant corruption and misappropriation in their distribution so much so that every now and then people from every nook and corner of the state have been complaining of non-availability of any such facilities in govt. health centers in spite of state government’s moves of publishing the details of drugs supplied to each hospital every year in local newspapers. State government should seriously consider launching of State Health Insurance Scheme for BPL as well as lower middle class people of the state on the pattern of and in addition to National Health Insurance Scheme, so that poor people may be able to obtain medicines on BPL cards as and when required by them from drug sale outlets specially established for this purpose in every hospital of the state. State government should pay full cost of the premium amount for all BPL beneficiaries and a suitable proportion of the premium amount for lower income groups amongst the middle class (APL) also, considering the fact that we don’t have as large a BPL segment in our state as is found in other states of the country.
National Common Minimum Programme of the present UPA government at center had stipulated that ‘Special attention would be paid to the poorer sections in the matter of health care’. In this direction government of India has proposed to launch a new national health insurance scheme by the name of “Rashtriya Swasthya Bima Yojana” for families living Below Poverty Line (BPL) in its draft National Pharmaceutical Policy 2008 which is likely to be promulgated soon by the Union Ministry of Chemicals and Fertilizers. This Scheme shall be implemented in a phased manner. Initially it would be launched on a pilot basis in two districts of each state. Based on the experience gained therefrom, it would be extended to all families below poverty line throughout the country. Distinguishing feature of the scheme is that the Government of India shall pay full cost of the premium amount for all BPL beneficiaries, who shall be provided benefits on the basis of BPL/Health cards issued to them by the States. Benefit of hospitalization upto Rs. 15000 and for medicines as out-patients upto Rs.5000 per annum per family shall be made available. Scheme shall be implemented by the four public sector insurance companies in the country. Each Insurance company would shortlist chemist shops upto PHC/taluka level. A certain number of BPL families would be assigned to each selected chemist shop.
Chemist shops will maintain complete account of the medicines taken by the BPL persons and send the same to insurance companies from time to time. BPL family can approach any government doctor in the area. Based on the prescription of the government physician the BPL cardholder can approach the authorized chemist shop for obtaining medicines. He would be supplied medicines free of cost. The chemist would send the bill to the concerned insurance company that would reimburse him for the amount of the medicines purchased by the BPL family. The entire insurance premium on account of the BPL families would be paid by the government to the insurance companies. Medicines have to be provided on the basis of prescriptions by government doctors only. From the third year of operation of the scheme it would be suitably revised and extended to all parts of the country. The source of funding for this and other related schemes would be a health cess of 2% to be levied on various central taxes by the government on the analogy of education cess, which is likely to provide approx. Rs 6500 crores to the government. In order to ensure that the money collected from the cess is not diverted to other areas it shall be kept in a separate non-lapsable fund. This fund may be managed by an independent body specially designated for this purpose that may be called the National Public Health Board. In case there is difficulty in levying of health cess, government may provide funds amounting to Rs. 6500 crores which is equivalent to 0.02% of the GDP out of the general budget. Present expenditure on health is only 0.9% of GDP, whereas as per national common minimum programme, it is to be raised to 2 to 3 % of GDP.
Besides the above-mentioned scheme, draft National Pharmaceutical Policy also envisages to set up State/District Illness Assistance Funds (SIAFs) in all states with financial assistance from the central government. Larger allocation would be made by the central government towards already in-force National Illness Assistance Fund (NIAF). Revolving Funds for BPL families would be set up in all the central government hospitals and the states would also be asked to set up revolving funds in all the government hospitals for free treatment of BPL families. Further in order to increase the reach of poor people to these funds District Level Revolving Fund would also be maintained, whose quantum would be Rs. 1.00 crore. Initial amount of Rs. 1.00 crore would be provided by the central government; thereafter it would be shared on 50:50 basis between the centre and the states. The fund would be replenished as soon as the level of fund in a district falls below Rs. 50 lacs. Wide publicity would be given to the availability of funds at the district, state and central levels. Proposed allocation for these schemes is Rs. 1000 crores, that will be mainly generated through the above-mentioned health cess of around 2%. Some states are already making good use of these schemes for the BPL families through NIAF, while most of them have not yet set up the State Illness Assistance Funds.
In-order to increase accessibility of medicines to the BPL families efforts would be made to establish a District Drug Bank at each district level. Considering that there are 600 districts in the country an equal number of drug banks would be set up in a phased manner. These banks could be managed by Red Cross Societies, Medicare Societies or such other charitable bodies having liaison with the district level administration/hospitals. Various pharmaceutical manufacturers would be encouraged to donate generously to these drug banks - efforts would be made that they adopt one or two districts for this purpose. Such drug donations would be made eligible for tax exemption under the corporate tax. Alternately some prominent NGOs may come forward and volunteer setting up of such medicare societies in all the hospitals of the state on the lines of Medicare Relief Societies of Rajasthan that provide cheaper medicines to the common man through outlets known as Lifeline Fluid Stores that are set up within the hospital premises.
All lucrative intricacies of these patient-friendly schemes apart, people at large are quite skeptical about their success in terms of actual transfer of all the benefits to the truly deserving sections of our society, in view of the past performance of other central schemes that have most of the times fallen prey to massive corruption, nepotism and favourtism. However the checks and measures put forth by the government this time seem to be quite promising and one can only hope that the target population of these schemes will be more vigilant and aware of their rights this time so as to take full advantage of these schemes and at the same time implementation and monitoring aspects of these schemes shall be made stringent enough by the govt. so as to prevent any pilferage or misuse by unscrupulous and corrupt elements. The UPA government at the center had vowed in its common minimum programme to launch these schemes soon after coming to power. Now that their implementation has already got delayed so much, govt. should seriously consider reducing the proposed trial period of these schemes from two years to only one year. Further the BPL families should be able to procure free medicines from chosen medical stores throughout the state not merely from the stores of their native areas.
Further in our state though medicines are supplied through two provincial medical stores to almost all hospitals for free distribution among patients, there have been reports of rampant corruption and misappropriation in their distribution so much so that every now and then people from every nook and corner of the state have been complaining of non-availability of any such facilities in govt. health centers in spite of state government’s moves of publishing the details of drugs supplied to each hospital every year in local newspapers. State government should seriously consider launching of State Health Insurance Scheme for BPL as well as lower middle class people of the state on the pattern of and in addition to National Health Insurance Scheme, so that poor people may be able to obtain medicines on BPL cards as and when required by them from drug sale outlets specially established for this purpose in every hospital of the state. State government should pay full cost of the premium amount for all BPL beneficiaries and a suitable proportion of the premium amount for lower income groups amongst the middle class (APL) also, considering the fact that we don’t have as large a BPL segment in our state as is found in other states of the country.
Impact of new patent regime on prices of medicines
On January 1st, 2005 India woke up to a new patent regime. Post GATT regime, drug prices were likely to surge up in a gradual, sustained and imperceptible manner to an all time high. Despite that this amendment was inevitable because India is a signatory to the World Trade Organization (WTO) and its Dunkel Draft proposals. WTO has 125 members out of which 77 members including India have signed the Dunkel Draft on April 15, 1994 at Marakash. Dunkel Draft comprises of four main areas viz., GATT (General Agreement on Tariffs and Trade), TRIPS (Trade related Intellectual Property Rights), TRIMS (Trade related Investment Measures) and GATS (General Agreement on Trade and Services). Of these, TRIPS and GATT have a direct bearing on the pharmaceutical industry whereas other areas of the draft have an impact in the form of funding or manpower. TRIMS proposals necessitate that foreign investment be made at par with national sector, without any export obligations, with no obligations to use local raw materials or components and to allow open competition. TRIPS proposals cover patents, copyrights, trade marks, designs and trade secrets. So far as copyrights, trademarks and designs are concerned there are no major controversies since the Indian laws are at par with the standards proposed vide TRIPS. However a major conflict between Indian Patents Act, 1970 and TRIPS proposals is in relation to the patents and trade secrets.
Dunkel Draft requires all member countries to introduce new patent regimes and to align their legislations on intellectual properties like new drug molecules, agro-chemicals etc in conformity with their obligations under TRIPS and GATT agreements. It also accorded India a ten year transition period upto Dec., 31st, 2004. During this period, patent office in India was to receive applications for product patents w.e.f., January 1, 1995. All patent applications were however to be kept in a mail box (also called black box) by the Controller of Patents and were not to be opened or registered before Jan., 1, 2005. Since the transition period is about to end now, around 5000 applications for product patents have been received by the Controller General of Patents which are to be examined after Jan., 01, 2005 for subsequent registration or rejection, as the case may be. In the event of all these applications being accepted, 5000 basic drug molecules will fall under patent regime whose prices will be subsequently determined by their patentees commensurate to their exclusive marketing rights afforded by the new regime. As this process of examination and registration of patent applications will be carried forward, more and more drugs will fall under patent regime thereby conferring exclusive rights to their original inventors and thereby leading to a sustained and impalpable, yet considerable hike in their market prices. It is noteworthy that the rise in drug prices will not be as abrupt and visible as the rise in petrol prices. The effects will be explicitly visible only after a few months of the enforcement of new regime.
However implementation of the new patent regime w.e.f. Jan., 01, 2005 requires third amendment to be made in the existing Indian Patents Act of 1970 (IPA). Two amendments have already been made in this Act in order to bring it at par with the TRIPS and GATT provisions-one in 1999 (made effective retrospectively from January 01, 1995) and the other in 2002 (made effective from May 20, 2003). Present Patents Act provides patents only for processes and not for products. An Indian manufacturer is allowed to manufacture the drug developed by some other company by a different process, but as per TRIPS, this will not happen since the drug molecule (product) itself would be patented. This implies that the owner of the product patent will have a right to exclude third parties from making, using, offering for sale, selling or importing the product. Those owning a product or a process patent can totally control and direct the import of the product for sale in India. Moreover the amendment of IPA also provides for pipeline protection of the intellectual property before final registration or rejection of the patent application i.e., full control over a new drug molecule by way of exclusive marketing rights for a period of five years or till the product patent is granted or rejected whichever is earlier. The duration of patents according to IPA, 1970 is 7 years for process patents and 14 years for product patents from the date of registration. Under TRIPS, patent right can be retained for twenty years and the patent term can be extended by another twenty years as the product patent holder can seek a process patent on the expiry of the product patent claiming novelty of process, new dosage form or a new combination with some old drugs etc.
Under old patent regime anyone could use the patent by paying a fixed royalty as determined by the Controller of Patents. The Controller of Patents on public demand or depending upon the situation could grant license to manufacture the same drug to another person. But under the new regime of TRIPS, Indian manufacturer will have either to wait for 10-12 years to start manufacturing the drug molecule which has been invented by someone else. Alternatively he will have to pay a huge sum as royalty to the patentee to manufacture that drug with a view to compensate for the manufacturer’s investments made into developing that drug. Thus the drug prices are likely to go up by a whopping 10-25%.
The amendment to the Patents Act, 1970 that is due from Jan 01, 2005 will basically be a substantive amendment from the view point of the pharmaceutical and agro-chemical industry. Apart from drug prices, this amendment also has implications on other aspects like the availability of drugs, public health issues and implications for the Indian industry that has hitherto basically operated and flourished through reverse engineering of drugs. Reverse engineering means the manufacture of drugs and pharmaceuticals by Indian companies through processes and techniques developed by the R&D efforts of mostly other multi-national companies (MNCs). In view of the high business and commercial stakes involved in any change in India’s patent regime, the pharmaceutical sector has been sharply divided in its views. Perspectives range from maintenance of the status-quo to renegotiation of TRIPS agreement, to stronger provisions for protecting domestic industry, to introduction of product patent protection at the earliest etc.
Those opposing the TRIPS regime opine that Indian Patents Act has helped the Indian pharmaceutical companies to grow by leaps and bounds and enabled them to manufacture medicines at low costs as well as to increase exports. The prices of Indian manufactured drugs are considered to be the lowest in the world. With a patent period of only 7-14 years (of which usually 3-4 years are spent in developing the drug molecule), several manufacturers were able to produce the same drug which led to competition and subsequent lowering of drug prices without compromising on their quality. It is now apprehended that as an aftermath of implementation of TRIPS proposals, drugs prices will sharply rise, national health-care programmes for the poor will be affected because operating costs will be high and unaffordable, investments in drug industry will be low and growth and exports will also decline. TRIPS proposals provide immense rights to the patentee. He can demand a huge sum as royalty. After expiry of product patency, the inventor can enjoy extension for another 20 years. This patency may be extended to cover new dosage forms or combinations of old drugs. The inventor shall hold exclusive rights on marketing, using, selling or exporting the drug. This implies that in case of shortage, government cannot import the drug without prior permission of the inventor. All this will lead to more dependence on imports and a consequent price rise.
Supporters of TRIPS on the other hand argue that the use of costly, patented drugs can be replaced by off-patented drugs. This would mean making already existing drugs of less efficacy or more side-effects available to poor patients in place of new and better drug molecules that would evolve in future. Consequently only rich people can have the benefit of new drugs while the poor will continue to be treated with old medicines. Govt. agencies also argue that there are sufficient provisions to check prices and ensure prompt availability of patented products, however these provisions can be applied only after the expiry of the term of patent. These provisions include introduction of Bolar System and Parallel Import System. It is needless to discuss these provisions further since they can not be enforced until 20-40 years after a new drug molecule has been developed by some pharmaceutical company. Moreover in all likelihood the new drug molecule would have become obsolete by then and lost its suitability, reliability and efficacy to a considerable extent. Union Ministry of Chemicals and Fertilizers has expressed its helplessness in stalling the proposed patents amendment bill on the pretext that TRIPS agreement is a legal fact and its obligations are binding on all signatories including India who have drawn other monetary benefits from WTO in lieu of signing this agreement. Now only a consensus among all WTO members can lead to any change in the TRIPS agreement and per-se there are no indications at this stage that the obligations of developing countries in respect of product patent regime shall be diluted or revised.
While commenting on the new regime, ASSOCHAM in its discussion paper has opined that while introduction of a product patent regime in all fields of technology will align the domestic law with the international obligations of the country, it will also help India to exploit its growing strength in research ability, not only in pharmaceuticals and agro-chemicals but also in bio-technology. They have pointed out that the product patents are already available in many areas even under the earlier Act e.g., a novel device, novel electronic systems, synergistic paint/cement compositions etc. However product patents relating to the important areas of pharmaceuticals, agrochemicals and food products will have to be made available after 01-01-2005. Therefore they recommend that the present Patents Act will have to be amended.
In defense of its plans to implement the new product patent regime, Govt. of India has assured that the following safeguards have been taken to ensure minimum effect of TRIPS proposals on common people.
1) Almost all drugs on the essential list of WHO and India are outside patent protection. Further, for essential drugs under patent protection, alternatives are available in most cases.
2) The existing patent law is fully equipped to deal with issues relating to
non-availability of drugs and/or exploitative pricing. Elaborate safeguards have been incorporated in the law for compulsory licensing, government use, parallel imports and assumption/revocation of patent rights in cases of health-related national/public urgency.
3) India also has a strong drugs price control mechanism to ensure availability of drugs at reasonable prices.
4) The development of new drugs and pharmaceuticals to meet emerging challenges involves substantive R&D initiatives and huge investments. The near total reliance of the Indian pharmaceutical sector on reverse engineering impacts adversely on substantial foreign investment in the pharmaceutical sector as also on India’s own emergence as a technology and R&D driven economy.
5) It is not appropriate to link the state of public health in India almost totally to the presence or absence of a product patent regime. In India, the expenditure on the health care system is reportedly around 2% of the GDP, which is quite low as compared to 8% - 10% recommended by WHO. Health concerns are, therefore, to be primarily addressed through a more comprehensive set of initiatives involving investments, infrastructure development, HRD etc.
6) India is developing a modern patent administration to cope up with the new challenges.
All said and done, though critics agree with the govt. view that after the introduction of new patent regime, quality of drugs will drastically improve since there will be more investments by both national and foreign concerns on R&D efforts, they fear that availability of good quality drugs will only be a distant dream for the poor people who cannot afford to pay for the huge investments of MNCs on their R&D inputs. Critics also believe that the small scale industry will be subjected to extinction thus again raising doubts on the availability of drugs to rural masses for various healthcare schemes. They opine that the GOI wants to earn foreign exchange, initiate foreign investment and increase exports by implementing GATT proposals. If India rejects GATT and Dunkel Draft agreements now, it is feared that there will be an erosion of its credibility in the international fora since it has availed of the entire transition period under TRIPS agreement and in the event of any default at this stage, developed countries will use their economic might to throttle India by raising a dispute against it in the WTO. Given these aspersions, a new product patent regime in compliance with TRIPS and GATT proposals seems to be in the offing and a subsequent drug price hike in near future seem inevitable. For the time being, all eyes are on the fate of Patents Amendment Bill that will be tabled in the ongoing winter session of the Parliament of India.
Dunkel Draft requires all member countries to introduce new patent regimes and to align their legislations on intellectual properties like new drug molecules, agro-chemicals etc in conformity with their obligations under TRIPS and GATT agreements. It also accorded India a ten year transition period upto Dec., 31st, 2004. During this period, patent office in India was to receive applications for product patents w.e.f., January 1, 1995. All patent applications were however to be kept in a mail box (also called black box) by the Controller of Patents and were not to be opened or registered before Jan., 1, 2005. Since the transition period is about to end now, around 5000 applications for product patents have been received by the Controller General of Patents which are to be examined after Jan., 01, 2005 for subsequent registration or rejection, as the case may be. In the event of all these applications being accepted, 5000 basic drug molecules will fall under patent regime whose prices will be subsequently determined by their patentees commensurate to their exclusive marketing rights afforded by the new regime. As this process of examination and registration of patent applications will be carried forward, more and more drugs will fall under patent regime thereby conferring exclusive rights to their original inventors and thereby leading to a sustained and impalpable, yet considerable hike in their market prices. It is noteworthy that the rise in drug prices will not be as abrupt and visible as the rise in petrol prices. The effects will be explicitly visible only after a few months of the enforcement of new regime.
However implementation of the new patent regime w.e.f. Jan., 01, 2005 requires third amendment to be made in the existing Indian Patents Act of 1970 (IPA). Two amendments have already been made in this Act in order to bring it at par with the TRIPS and GATT provisions-one in 1999 (made effective retrospectively from January 01, 1995) and the other in 2002 (made effective from May 20, 2003). Present Patents Act provides patents only for processes and not for products. An Indian manufacturer is allowed to manufacture the drug developed by some other company by a different process, but as per TRIPS, this will not happen since the drug molecule (product) itself would be patented. This implies that the owner of the product patent will have a right to exclude third parties from making, using, offering for sale, selling or importing the product. Those owning a product or a process patent can totally control and direct the import of the product for sale in India. Moreover the amendment of IPA also provides for pipeline protection of the intellectual property before final registration or rejection of the patent application i.e., full control over a new drug molecule by way of exclusive marketing rights for a period of five years or till the product patent is granted or rejected whichever is earlier. The duration of patents according to IPA, 1970 is 7 years for process patents and 14 years for product patents from the date of registration. Under TRIPS, patent right can be retained for twenty years and the patent term can be extended by another twenty years as the product patent holder can seek a process patent on the expiry of the product patent claiming novelty of process, new dosage form or a new combination with some old drugs etc.
Under old patent regime anyone could use the patent by paying a fixed royalty as determined by the Controller of Patents. The Controller of Patents on public demand or depending upon the situation could grant license to manufacture the same drug to another person. But under the new regime of TRIPS, Indian manufacturer will have either to wait for 10-12 years to start manufacturing the drug molecule which has been invented by someone else. Alternatively he will have to pay a huge sum as royalty to the patentee to manufacture that drug with a view to compensate for the manufacturer’s investments made into developing that drug. Thus the drug prices are likely to go up by a whopping 10-25%.
The amendment to the Patents Act, 1970 that is due from Jan 01, 2005 will basically be a substantive amendment from the view point of the pharmaceutical and agro-chemical industry. Apart from drug prices, this amendment also has implications on other aspects like the availability of drugs, public health issues and implications for the Indian industry that has hitherto basically operated and flourished through reverse engineering of drugs. Reverse engineering means the manufacture of drugs and pharmaceuticals by Indian companies through processes and techniques developed by the R&D efforts of mostly other multi-national companies (MNCs). In view of the high business and commercial stakes involved in any change in India’s patent regime, the pharmaceutical sector has been sharply divided in its views. Perspectives range from maintenance of the status-quo to renegotiation of TRIPS agreement, to stronger provisions for protecting domestic industry, to introduction of product patent protection at the earliest etc.
Those opposing the TRIPS regime opine that Indian Patents Act has helped the Indian pharmaceutical companies to grow by leaps and bounds and enabled them to manufacture medicines at low costs as well as to increase exports. The prices of Indian manufactured drugs are considered to be the lowest in the world. With a patent period of only 7-14 years (of which usually 3-4 years are spent in developing the drug molecule), several manufacturers were able to produce the same drug which led to competition and subsequent lowering of drug prices without compromising on their quality. It is now apprehended that as an aftermath of implementation of TRIPS proposals, drugs prices will sharply rise, national health-care programmes for the poor will be affected because operating costs will be high and unaffordable, investments in drug industry will be low and growth and exports will also decline. TRIPS proposals provide immense rights to the patentee. He can demand a huge sum as royalty. After expiry of product patency, the inventor can enjoy extension for another 20 years. This patency may be extended to cover new dosage forms or combinations of old drugs. The inventor shall hold exclusive rights on marketing, using, selling or exporting the drug. This implies that in case of shortage, government cannot import the drug without prior permission of the inventor. All this will lead to more dependence on imports and a consequent price rise.
Supporters of TRIPS on the other hand argue that the use of costly, patented drugs can be replaced by off-patented drugs. This would mean making already existing drugs of less efficacy or more side-effects available to poor patients in place of new and better drug molecules that would evolve in future. Consequently only rich people can have the benefit of new drugs while the poor will continue to be treated with old medicines. Govt. agencies also argue that there are sufficient provisions to check prices and ensure prompt availability of patented products, however these provisions can be applied only after the expiry of the term of patent. These provisions include introduction of Bolar System and Parallel Import System. It is needless to discuss these provisions further since they can not be enforced until 20-40 years after a new drug molecule has been developed by some pharmaceutical company. Moreover in all likelihood the new drug molecule would have become obsolete by then and lost its suitability, reliability and efficacy to a considerable extent. Union Ministry of Chemicals and Fertilizers has expressed its helplessness in stalling the proposed patents amendment bill on the pretext that TRIPS agreement is a legal fact and its obligations are binding on all signatories including India who have drawn other monetary benefits from WTO in lieu of signing this agreement. Now only a consensus among all WTO members can lead to any change in the TRIPS agreement and per-se there are no indications at this stage that the obligations of developing countries in respect of product patent regime shall be diluted or revised.
While commenting on the new regime, ASSOCHAM in its discussion paper has opined that while introduction of a product patent regime in all fields of technology will align the domestic law with the international obligations of the country, it will also help India to exploit its growing strength in research ability, not only in pharmaceuticals and agro-chemicals but also in bio-technology. They have pointed out that the product patents are already available in many areas even under the earlier Act e.g., a novel device, novel electronic systems, synergistic paint/cement compositions etc. However product patents relating to the important areas of pharmaceuticals, agrochemicals and food products will have to be made available after 01-01-2005. Therefore they recommend that the present Patents Act will have to be amended.
In defense of its plans to implement the new product patent regime, Govt. of India has assured that the following safeguards have been taken to ensure minimum effect of TRIPS proposals on common people.
1) Almost all drugs on the essential list of WHO and India are outside patent protection. Further, for essential drugs under patent protection, alternatives are available in most cases.
2) The existing patent law is fully equipped to deal with issues relating to
non-availability of drugs and/or exploitative pricing. Elaborate safeguards have been incorporated in the law for compulsory licensing, government use, parallel imports and assumption/revocation of patent rights in cases of health-related national/public urgency.
3) India also has a strong drugs price control mechanism to ensure availability of drugs at reasonable prices.
4) The development of new drugs and pharmaceuticals to meet emerging challenges involves substantive R&D initiatives and huge investments. The near total reliance of the Indian pharmaceutical sector on reverse engineering impacts adversely on substantial foreign investment in the pharmaceutical sector as also on India’s own emergence as a technology and R&D driven economy.
5) It is not appropriate to link the state of public health in India almost totally to the presence or absence of a product patent regime. In India, the expenditure on the health care system is reportedly around 2% of the GDP, which is quite low as compared to 8% - 10% recommended by WHO. Health concerns are, therefore, to be primarily addressed through a more comprehensive set of initiatives involving investments, infrastructure development, HRD etc.
6) India is developing a modern patent administration to cope up with the new challenges.
All said and done, though critics agree with the govt. view that after the introduction of new patent regime, quality of drugs will drastically improve since there will be more investments by both national and foreign concerns on R&D efforts, they fear that availability of good quality drugs will only be a distant dream for the poor people who cannot afford to pay for the huge investments of MNCs on their R&D inputs. Critics also believe that the small scale industry will be subjected to extinction thus again raising doubts on the availability of drugs to rural masses for various healthcare schemes. They opine that the GOI wants to earn foreign exchange, initiate foreign investment and increase exports by implementing GATT proposals. If India rejects GATT and Dunkel Draft agreements now, it is feared that there will be an erosion of its credibility in the international fora since it has availed of the entire transition period under TRIPS agreement and in the event of any default at this stage, developed countries will use their economic might to throttle India by raising a dispute against it in the WTO. Given these aspersions, a new product patent regime in compliance with TRIPS and GATT proposals seems to be in the offing and a subsequent drug price hike in near future seem inevitable. For the time being, all eyes are on the fate of Patents Amendment Bill that will be tabled in the ongoing winter session of the Parliament of India.
Paucity of drug inspectorate staff in J&K - major impediment in effective QC of Drugs
Over the past few years, an ever increasing concern is being
witnessed among the masses in regard to progressively deteriorating quality
of drugs and related services. Among a host of social, political, economic,
legal and administrative factors that are responsible for the prevailing
scenario, one big factor is the inadequacy of skilled manpower available
with the Drug and Food Control Organization, J&K in the shape of Drug
Inspectors.
As per official figures available with the health dept., there
are 7870 licensed retail and wholesale drug dealers registered in the state
of J&K with only 16 posts of Drug Inspectors to monitor and inspect them,
thus putting a burden of around 500 sale premises on each drug inspector
whereas internationally accepted norms require one drug inspector for every
100 drug sale outlets. It is worth mentioning that this figure of 7870
outlets does not include first aid centers, primary health centers,
allopathic dispensaries, sub-district and district hospitals that exist in
each district of the state in addition to blood banks, manufacturing
establishments and unauthorised drug stores. Thus the workforce currently
available with Drugs Control Department is not sufficient enough to fully
cater to the actual field requirements.
Guidelines put forth by well-known Hathi Committee (1975),
National Human Rights Commission (1999), Standing Committee on Petroleum and Chemicals (2001) have also prescribed one drug inspector for every 100
sale outlets or 25 manufacturing establishments. Accordingly there is need
for one drug inspector at every block level in the state whereas at present
only one drug inspector is managing each district and sometimes even two
districts of the state.
There are a total of 103 medical blocks in the
state. More than a year ago, a proposal framed by this author on behalf of
the J&K Pharmacy Graduates Association favouring creation of 90 fresh
posts of Drug Inspectors at Block level in the state was endorsed by the
Drugs Controller of J&K state and subsequently accepted by the Ministry of
Health and F.W., J&K for further consideration. However even after expiry
of more than a year, the said proposal is still lying pending with the
Ministry of Planning and Finance though all the concerned authorities had
assured prompt and favourable consideration of the same. The financial
implications of the proposal have been worked out at a meager amount of Rs.
1.10 crores per annum. This much financial burden on the state exchequer
should be quite bearable in the face of its potential benefits in terms of
an effective and fool-proof drug control mechanism in the state.
Moreover, at present, drugs falling under alternative systems of
medicine including Ayurveda, Unani, Siddha and Homeopathy are not regulated
by any legal framework so far as their sale, storage or distribution is
concerned. Though provisions relating to these type of drugs have been
outlined in the Drugs and Cosmetics Act, 1940 and Rules thereunder, these
provisions have not been enforced unlike other provisions relating to drugs
belonging to allopathic system of medicine. Therefore in case proposal for
the creation of 90 fresh posts of drug inspectors at block level is cleared
by the state govt., new appointees can be suitably empowered to inspect and
monitor drug stores dealing with alternative systems of medicine in their
respective blocks. Similarly diagnostic laboratories exist in every nook
and corner of the state without any license or proper registration because
of non- implementation of the Clinical Establishments Act in the state.
Proposed appointments of drug inspectors at block level can pave way for
the regular inspection, checking and statutory control of these
laboratories too provided relevant powers and authority is vested unto
them.
Govt. of India had envisaged under Para 13 & 19 of its National
Drug Policy, 1986, modified in 1994 the need to augment and strengthen drug
control and enforcement (inspectorate) staff in each state including J&K
with a view to enable statutory inspections to be undertaken as provided
under the Act. Funds were to be sanctioned under centrally sponsored
schemes for this augmentation. However, no remarkable augmentation has
taken place at least in the J&K state even till National Pharmaceutical
Policy 2002 was promulgated in February 2002 or thereafter. Ironically our
state of J&K does not have a Drug Policy of its own that could address our
regional requirements vis-a-vis making safe, effective and standard quality
drugs available to masses. In a previous article of mine, I had voiced some
concerns on this issue but of no avail till date.
Drug inspectors are the only personnel legally empowered to enforce
various provisions of the Drugs and Cosmetics Act. We should have them in
adequate numbers so that they share a manageable jurisdiction and workload.
Further, they need to be provided with adequate accommodation,
transportation, communication and judicial assistance facilities in order
to ensure prompt action. Govt. cites lack of finances as prime reasons for
inaction in these areas. However it is said that whenever adequate funds
are available with the state govt., these considerations always take a back
seat and remain last priorities with them. At present, the available
inspectorate staff spend most of their time in courts pleading for various
prosecutions launched by them and they are left with little time to conduct
any secret probe against possible spurious drug rackets operating in their
jurisdiction areas. There is urgent need to create separate intelligence
and legal cells in the state with adequate provisions of secret funds and
incentives for informers. It is therefore time to revive, revamp and
reconstruct our drug control administration on the pattern of other states
like FDA, Maharashtra so as to make drugs of best quality, safety and
efficacy available to consumers at reasonable rates. Govt. should stop
dilly-dallying the proposal of block-wise creation of 90 posts and the
proposal should be approved in the larger interests of the common masses.
witnessed among the masses in regard to progressively deteriorating quality
of drugs and related services. Among a host of social, political, economic,
legal and administrative factors that are responsible for the prevailing
scenario, one big factor is the inadequacy of skilled manpower available
with the Drug and Food Control Organization, J&K in the shape of Drug
Inspectors.
As per official figures available with the health dept., there
are 7870 licensed retail and wholesale drug dealers registered in the state
of J&K with only 16 posts of Drug Inspectors to monitor and inspect them,
thus putting a burden of around 500 sale premises on each drug inspector
whereas internationally accepted norms require one drug inspector for every
100 drug sale outlets. It is worth mentioning that this figure of 7870
outlets does not include first aid centers, primary health centers,
allopathic dispensaries, sub-district and district hospitals that exist in
each district of the state in addition to blood banks, manufacturing
establishments and unauthorised drug stores. Thus the workforce currently
available with Drugs Control Department is not sufficient enough to fully
cater to the actual field requirements.
Guidelines put forth by well-known Hathi Committee (1975),
National Human Rights Commission (1999), Standing Committee on Petroleum and Chemicals (2001) have also prescribed one drug inspector for every 100
sale outlets or 25 manufacturing establishments. Accordingly there is need
for one drug inspector at every block level in the state whereas at present
only one drug inspector is managing each district and sometimes even two
districts of the state.
There are a total of 103 medical blocks in the
state. More than a year ago, a proposal framed by this author on behalf of
the J&K Pharmacy Graduates Association favouring creation of 90 fresh
posts of Drug Inspectors at Block level in the state was endorsed by the
Drugs Controller of J&K state and subsequently accepted by the Ministry of
Health and F.W., J&K for further consideration. However even after expiry
of more than a year, the said proposal is still lying pending with the
Ministry of Planning and Finance though all the concerned authorities had
assured prompt and favourable consideration of the same. The financial
implications of the proposal have been worked out at a meager amount of Rs.
1.10 crores per annum. This much financial burden on the state exchequer
should be quite bearable in the face of its potential benefits in terms of
an effective and fool-proof drug control mechanism in the state.
Moreover, at present, drugs falling under alternative systems of
medicine including Ayurveda, Unani, Siddha and Homeopathy are not regulated
by any legal framework so far as their sale, storage or distribution is
concerned. Though provisions relating to these type of drugs have been
outlined in the Drugs and Cosmetics Act, 1940 and Rules thereunder, these
provisions have not been enforced unlike other provisions relating to drugs
belonging to allopathic system of medicine. Therefore in case proposal for
the creation of 90 fresh posts of drug inspectors at block level is cleared
by the state govt., new appointees can be suitably empowered to inspect and
monitor drug stores dealing with alternative systems of medicine in their
respective blocks. Similarly diagnostic laboratories exist in every nook
and corner of the state without any license or proper registration because
of non- implementation of the Clinical Establishments Act in the state.
Proposed appointments of drug inspectors at block level can pave way for
the regular inspection, checking and statutory control of these
laboratories too provided relevant powers and authority is vested unto
them.
Govt. of India had envisaged under Para 13 & 19 of its National
Drug Policy, 1986, modified in 1994 the need to augment and strengthen drug
control and enforcement (inspectorate) staff in each state including J&K
with a view to enable statutory inspections to be undertaken as provided
under the Act. Funds were to be sanctioned under centrally sponsored
schemes for this augmentation. However, no remarkable augmentation has
taken place at least in the J&K state even till National Pharmaceutical
Policy 2002 was promulgated in February 2002 or thereafter. Ironically our
state of J&K does not have a Drug Policy of its own that could address our
regional requirements vis-a-vis making safe, effective and standard quality
drugs available to masses. In a previous article of mine, I had voiced some
concerns on this issue but of no avail till date.
Drug inspectors are the only personnel legally empowered to enforce
various provisions of the Drugs and Cosmetics Act. We should have them in
adequate numbers so that they share a manageable jurisdiction and workload.
Further, they need to be provided with adequate accommodation,
transportation, communication and judicial assistance facilities in order
to ensure prompt action. Govt. cites lack of finances as prime reasons for
inaction in these areas. However it is said that whenever adequate funds
are available with the state govt., these considerations always take a back
seat and remain last priorities with them. At present, the available
inspectorate staff spend most of their time in courts pleading for various
prosecutions launched by them and they are left with little time to conduct
any secret probe against possible spurious drug rackets operating in their
jurisdiction areas. There is urgent need to create separate intelligence
and legal cells in the state with adequate provisions of secret funds and
incentives for informers. It is therefore time to revive, revamp and
reconstruct our drug control administration on the pattern of other states
like FDA, Maharashtra so as to make drugs of best quality, safety and
efficacy available to consumers at reasonable rates. Govt. should stop
dilly-dallying the proposal of block-wise creation of 90 posts and the
proposal should be approved in the larger interests of the common masses.
Innovative PharmD course - Prospects and constraints
In the recent years pharmacy education has grown to generate highly skilled and technical manpower to manage the wide spectrum of pharmaceutical activities associated with the manufacture and sale of medicines. In India, pharma industry is on ascent, with annual growth of 9% to attain estimated 20 billion Euro business by 2015. Currently there are 600 degree and 500 diploma institutions churning out 50,000 graduates, 35,000 diploma holders, 1000 postgraduates and about 300 doctorates every year in India.
In spite of these numbers, pharmacy profession is relatively young in India and has chequered path. Today there is a paradigm shift from the existing industry oriented approach to service and patient-centered curriculum in pharmaceutical academic parlance. There is a drastic change in the approach of Pharmacy Council of India (PCI) to the problems plaguing the profession. There is also a glaring attitudinal change in the student and teacher perception of pharmacy profession. These indications auger well for the profession in realizing the ultimate objective of producing a seven star pharmacist.
In India, although pharmaceutical industry has advanced in last 25 years, the pharmacist continues to remain in backstage of pharmaceutical industry and a salesperson in retail pharmacy. This image has to change, which can be attained by raising the educational standard of pharmacists. No serious attempt has been there to modify the curricula of pharmacy education in India since many years in contrast to manufacturing standards, QC practices, research activities and clinical practices which have undergone tremendous changes.
To fulfil these objectives and to improve the standards of pharmacy education in India, particularly with respect to the emerging discipline of clinical pharmacy, Pharmacy Council of India (PCI) in 2008 started a six year integrated Pharm D course.
The PCI initially approved 28 colleges to start Pharm D course from current academic year. Initially, the permission to start the Pharm D will be issued for a period of one year and will be renewed on yearly basis subject to verification of facilities and achievements of annual targets. PCI has designated a regular panel of inspectors for periodic inspection of pharmacy colleges having Pharm D course throughout the country. This will be a critical responsibility on PCI considering the fact that several pharmacy colleges offering B Pharm degree do not have basic lab facilities and qualified faculty. Any lapse in monitoring and periodic inspection of these Pharm D institutions can tempt their managements to compromise on facilities and thereby devalue this advanced course.
Pharm D programme (Doctor of Pharmacy - six years programme). It is a six years program during which five years comprise of the academic session and final year is for internship in the hospital.
Eligibility
10+2 (M.P.C./Bi.P.C.) or D.Pharm
Subjects Offered:
First year: Human Anatomy and Physiology, Pharmaceutics, Medicinal Biochemistry, Pharmaceutical Organic Chemistry, Pharmaceutical Inorganic Chemistry, Remedial Mathematics/ Biology.
Second Year: Pathophysiology, Pharmaceutical Microbiology, Pharmacognosy & Phytopharmaceuticals, Pharmacology-I, Community Pharmacy, Pharmacotherapeutics-I.
Third Year: Pharmacology-II, Pharmaceutical Analysis, Pharmacotherapeutics-II, Pharmaceutical Jurisprudence, Medicinal Chemistry, Pharmaceutical Formulations.
Fourth Year: Pharmacotherapeutics-III, Hospital Pharmacy, Clinical Pharmacy, Biostatistics & Research Methodology, Biopharmaceutics & Pharmacokinetics, Clinical Toxicology
Fifth Year: Clinical Research, Pharmacoepidemiology and Pharmacoeconomics, Clinical Pharmacokinetics & Pharmacotherapeutic Drug Monitoring, Clerkship, Project work (Six Months).
Sixth Year: Internship or residency training including postings in speciality units. Student should independently provide the clinical pharmacy services to the allotted wards.
(i) Six months in General Medicine department, and
(ii) Two months each in three other speciality departments
Hospital details to link with institute to run Pharm D & Pharm D (Post Baccalaureate) courses:
Hospital should have teaching facility (minimum 300 beds), Pharmacy Practice Department, Specialty of Medicine and any three of the following:
• Surgery
• Pediatrics
• Gynecology and Obstetrics
• Psychiatry
• Skin and VD
• Orthopedics
Pharm D Post Baccalaureate programme: It is a three year programme with two years of study and one year internship or residency.
Eligibility: B.Pharm
Number of seats under each programme allowed as per PCI
Pharm D Programme – 30 students.
Pharm D (Post Baccalaureate) Programme – 10 students
(Ref: www.pci.nic.in)
SALIENT FEATURES OF PHARM D COURSE
1. All subjects taught during B Pharm and M Pharm (Pharmacy Practice) are thoroughly covered including key subjects like Pharmaceutics, Pharmacognosy, Pharmaceutical Chemistry, Pharmacology, Microbiology, Biochemistry, Jurisprudence, Medicinal Chemistry, Biopharmaceutics and Pharmaceutical Formulations.
2. Subjects like Clinical Pharmacy, Community Pharmacy and Hospital Pharmacy have been introduced as independent subjects.
3. New subjects like Clinical Research, Pharmaco-epidemiology, Pharmaco-economics, Biostatistics, Pathophysiology, Clinical Toxicology have been introduced.
4. Pharmacotherapeutics is being taught in three parts spread over three years which will train the pharmacists to meet the challenges of clinical set up and equip them well to actively participate and contribute during ward rounds. This area has so far remained grey for Pharmacists depriving them of clinical rounds and decision making.
5. Hospital Posting: Every student shall be posted in constituent hospital for a period of not less than 50 hours to be covered in not less than 200 working days in each of second, third and fourth year of the course.
6. Clerkship (attending ward rounds on daily basis during fifth year of the course) followed by a seminar at its end.
7. Project work (spread over six months during fifth year of the course) to allow the student to develop data collection and reporting skills in the area of community, hospital and clinical pharmacy. This shall be carried out under the supervision of a teacher. Students will prepare a project report under the guidance of an approved teacher.
8. Internship or residency training for one year during sixth year of the course including postings in specialty units which includes six months in General Medicine department, and two months each in any other three specified specialty departments.
WHO has specifically emphasized the contribution of pharmacists in rational use of medicines by ensuring the pharmacist’s participation in ward rounds, advising medicines to in-patients, monitoring prescriptions, running medicine information centres, in Drug and Therapeutics Committee (DTC) etc. WHO wishes that a pharmacist should be a caregiver, decision maker, life-long learner, communicator, teacher, manager and leader. In order to shoulder these responsibilities, pharmacists need to be appropriately equipped through focused and suitable training which has so far been lacking.
It was with these objectives in mind that the six year integrated Pharm D course was conceived, designed, developed and notified by the PCI under the leadership of its dynamic president, Dr. B. Suresh in 2008. The course aims at rigorously training aspiring candidates in clinical pharmacy practice with one full year of internship in medical as well as surgical specialty wards besides six month long project work and six month long clerkship in a 350 bedded hospital.
The Pharm D course has met with a lot of appreciation and some criticism at the same time. Appreciation has been showered for taking concrete steps towards opening up new vistas in the practice of clinical, hospital and community pharmacy in India and criticism for high fee structure and fewer job opportunities in India. However President PCI, Dr. B. Suresh contends that the new course is actually aimed at opening up vast career opportunities for our pharmacy professionals abroad who have so far been finding it difficult to get licenses to practice pharmacy outside India. Besides, Dr. Suresh claims that the pass outs of the new course shall find more job prospects in fast expanding and flourishing Clinical Research Organizations (CRO) in India.
The Pharm D degree provides registered pharmacists the knowledge and skills of current diagnostic methods, treatment modalities, drug delivery system, therapeutic outcome, pharmaco-economics and pharmacotherapy to meet the rapid changes in the healthcare. The new course is intended to bring Indian pharmacy education at par with the western model and will provide opportunities for Indian students to practice in foreign countries too. Hitherto, the four year programme was not recognized in Western countries, thus severely affecting the job opportunities. Hence PCI contemplated this six year Pharm D course for international acceptability. Pharm D course is a step in the right direction and worth pursuing. However it needs to be made affordable and available at Govt. colleges/universities also. PCI needs to clarify whether Pharm D candidates can apply for Government jobs which stipulate B Pharm / M Pharm as mandatory qualification. All stakeholders need to work in tandem to uplift pharmacy profession and foster the practice of clinical pharmacy in India. Pharm D course is therefore a step ahead in the right direction.
In spite of these numbers, pharmacy profession is relatively young in India and has chequered path. Today there is a paradigm shift from the existing industry oriented approach to service and patient-centered curriculum in pharmaceutical academic parlance. There is a drastic change in the approach of Pharmacy Council of India (PCI) to the problems plaguing the profession. There is also a glaring attitudinal change in the student and teacher perception of pharmacy profession. These indications auger well for the profession in realizing the ultimate objective of producing a seven star pharmacist.
In India, although pharmaceutical industry has advanced in last 25 years, the pharmacist continues to remain in backstage of pharmaceutical industry and a salesperson in retail pharmacy. This image has to change, which can be attained by raising the educational standard of pharmacists. No serious attempt has been there to modify the curricula of pharmacy education in India since many years in contrast to manufacturing standards, QC practices, research activities and clinical practices which have undergone tremendous changes.
To fulfil these objectives and to improve the standards of pharmacy education in India, particularly with respect to the emerging discipline of clinical pharmacy, Pharmacy Council of India (PCI) in 2008 started a six year integrated Pharm D course.
The PCI initially approved 28 colleges to start Pharm D course from current academic year. Initially, the permission to start the Pharm D will be issued for a period of one year and will be renewed on yearly basis subject to verification of facilities and achievements of annual targets. PCI has designated a regular panel of inspectors for periodic inspection of pharmacy colleges having Pharm D course throughout the country. This will be a critical responsibility on PCI considering the fact that several pharmacy colleges offering B Pharm degree do not have basic lab facilities and qualified faculty. Any lapse in monitoring and periodic inspection of these Pharm D institutions can tempt their managements to compromise on facilities and thereby devalue this advanced course.
Pharm D programme (Doctor of Pharmacy - six years programme). It is a six years program during which five years comprise of the academic session and final year is for internship in the hospital.
Eligibility
10+2 (M.P.C./Bi.P.C.) or D.Pharm
Subjects Offered:
First year: Human Anatomy and Physiology, Pharmaceutics, Medicinal Biochemistry, Pharmaceutical Organic Chemistry, Pharmaceutical Inorganic Chemistry, Remedial Mathematics/ Biology.
Second Year: Pathophysiology, Pharmaceutical Microbiology, Pharmacognosy & Phytopharmaceuticals, Pharmacology-I, Community Pharmacy, Pharmacotherapeutics-I.
Third Year: Pharmacology-II, Pharmaceutical Analysis, Pharmacotherapeutics-II, Pharmaceutical Jurisprudence, Medicinal Chemistry, Pharmaceutical Formulations.
Fourth Year: Pharmacotherapeutics-III, Hospital Pharmacy, Clinical Pharmacy, Biostatistics & Research Methodology, Biopharmaceutics & Pharmacokinetics, Clinical Toxicology
Fifth Year: Clinical Research, Pharmacoepidemiology and Pharmacoeconomics, Clinical Pharmacokinetics & Pharmacotherapeutic Drug Monitoring, Clerkship, Project work (Six Months).
Sixth Year: Internship or residency training including postings in speciality units. Student should independently provide the clinical pharmacy services to the allotted wards.
(i) Six months in General Medicine department, and
(ii) Two months each in three other speciality departments
Hospital details to link with institute to run Pharm D & Pharm D (Post Baccalaureate) courses:
Hospital should have teaching facility (minimum 300 beds), Pharmacy Practice Department, Specialty of Medicine and any three of the following:
• Surgery
• Pediatrics
• Gynecology and Obstetrics
• Psychiatry
• Skin and VD
• Orthopedics
Pharm D Post Baccalaureate programme: It is a three year programme with two years of study and one year internship or residency.
Eligibility: B.Pharm
Number of seats under each programme allowed as per PCI
Pharm D Programme – 30 students.
Pharm D (Post Baccalaureate) Programme – 10 students
(Ref: www.pci.nic.in)
SALIENT FEATURES OF PHARM D COURSE
1. All subjects taught during B Pharm and M Pharm (Pharmacy Practice) are thoroughly covered including key subjects like Pharmaceutics, Pharmacognosy, Pharmaceutical Chemistry, Pharmacology, Microbiology, Biochemistry, Jurisprudence, Medicinal Chemistry, Biopharmaceutics and Pharmaceutical Formulations.
2. Subjects like Clinical Pharmacy, Community Pharmacy and Hospital Pharmacy have been introduced as independent subjects.
3. New subjects like Clinical Research, Pharmaco-epidemiology, Pharmaco-economics, Biostatistics, Pathophysiology, Clinical Toxicology have been introduced.
4. Pharmacotherapeutics is being taught in three parts spread over three years which will train the pharmacists to meet the challenges of clinical set up and equip them well to actively participate and contribute during ward rounds. This area has so far remained grey for Pharmacists depriving them of clinical rounds and decision making.
5. Hospital Posting: Every student shall be posted in constituent hospital for a period of not less than 50 hours to be covered in not less than 200 working days in each of second, third and fourth year of the course.
6. Clerkship (attending ward rounds on daily basis during fifth year of the course) followed by a seminar at its end.
7. Project work (spread over six months during fifth year of the course) to allow the student to develop data collection and reporting skills in the area of community, hospital and clinical pharmacy. This shall be carried out under the supervision of a teacher. Students will prepare a project report under the guidance of an approved teacher.
8. Internship or residency training for one year during sixth year of the course including postings in specialty units which includes six months in General Medicine department, and two months each in any other three specified specialty departments.
WHO has specifically emphasized the contribution of pharmacists in rational use of medicines by ensuring the pharmacist’s participation in ward rounds, advising medicines to in-patients, monitoring prescriptions, running medicine information centres, in Drug and Therapeutics Committee (DTC) etc. WHO wishes that a pharmacist should be a caregiver, decision maker, life-long learner, communicator, teacher, manager and leader. In order to shoulder these responsibilities, pharmacists need to be appropriately equipped through focused and suitable training which has so far been lacking.
It was with these objectives in mind that the six year integrated Pharm D course was conceived, designed, developed and notified by the PCI under the leadership of its dynamic president, Dr. B. Suresh in 2008. The course aims at rigorously training aspiring candidates in clinical pharmacy practice with one full year of internship in medical as well as surgical specialty wards besides six month long project work and six month long clerkship in a 350 bedded hospital.
The Pharm D course has met with a lot of appreciation and some criticism at the same time. Appreciation has been showered for taking concrete steps towards opening up new vistas in the practice of clinical, hospital and community pharmacy in India and criticism for high fee structure and fewer job opportunities in India. However President PCI, Dr. B. Suresh contends that the new course is actually aimed at opening up vast career opportunities for our pharmacy professionals abroad who have so far been finding it difficult to get licenses to practice pharmacy outside India. Besides, Dr. Suresh claims that the pass outs of the new course shall find more job prospects in fast expanding and flourishing Clinical Research Organizations (CRO) in India.
The Pharm D degree provides registered pharmacists the knowledge and skills of current diagnostic methods, treatment modalities, drug delivery system, therapeutic outcome, pharmaco-economics and pharmacotherapy to meet the rapid changes in the healthcare. The new course is intended to bring Indian pharmacy education at par with the western model and will provide opportunities for Indian students to practice in foreign countries too. Hitherto, the four year programme was not recognized in Western countries, thus severely affecting the job opportunities. Hence PCI contemplated this six year Pharm D course for international acceptability. Pharm D course is a step in the right direction and worth pursuing. However it needs to be made affordable and available at Govt. colleges/universities also. PCI needs to clarify whether Pharm D candidates can apply for Government jobs which stipulate B Pharm / M Pharm as mandatory qualification. All stakeholders need to work in tandem to uplift pharmacy profession and foster the practice of clinical pharmacy in India. Pharm D course is therefore a step ahead in the right direction.
Need for regional state-specific drug policies in India
India is a big country with a complex and diverse social, cultural, economic and political fabric. Constitutionally health is primarily a state responsibility. Hence although health and medicine policy are formulated and revised periodically by the Govt of India, the responsibility of its implementation lies chiefly with the state Govts. The National Pharmaceutical Policy addresses provisions relating to import, export, pricing, investment, R&D, industrial licensing and manufacture of medicines and pharmaceuticals. However by 2000, India had not achieved 13 out of the 17 goals laid down in the first National Health Policy of 1983. At regional level, each state of the Union has to address its local concerns on the basis of own requirements. These concerns pertain to effective quality control of medicines; rational prescribing and use of medicines; availability of safe and effective medicines in adequate quantities at Govt. centres; improved procurement, storage and distribution practices for medicines and other medical supplies; quality pharmaceutical and healthcare services; stringent enforcement of medicine related laws; adequate pharmacy and health education, research and training facilities at all academic and healthcare institutions; and indigenous manufacture of life-saving medicines.
Keeping with above concerns, each state frames state specific medicine policy that addresses key issues related to the availability of safe and effective medicines at affordable prices as well as to their rational prescribing, improved distribution and sale in accordance with the existing laws.
Many states like Karnataka, Kerala, West Bengal, Himachal Pradesh, Punjab, Delhi, Chattisgarh, Madhya Pradesh, Orissa etc; have their own state drug and health policy but not all states. Hence there is need to enhance the level of awareness about having such a policy and to make the decision makers realize the urgency to take notice of the need.
India’s health care delivery system is divided in four levels: rural health centres, district hospitals, tertiary care hospitals and teaching hospitals. Pharmaceutical policy in India is perceived primarily as an industrial policy rather than a health policy. Under the Constitution of India both the Central Govt and the States have concurrent duties for drug control, for safety, quality and efficacy. Public expenditure on drugs has generally remained low at about US$1 per capita. The public has to largely depend on out-of-pocket expenditure, purchasing medicines from chemists or paying private practitioners. While nearly 75% of health care, including medicines, is obtained from private sources, marginalised populations living in remote rural areas largely depend on public facilities. Considering the diverse nature of India, its population size and socio-cultural characteristics, and health care being state matter, there is need for framing drug and health policies at state level in order to cater to the local requirements and ensure proper implementation of Govt. programmes at the grass root level 1.
National Human Rights Commission (NHRC) recommends the adoption of a State essential drug policy in every state that ensures full availability of essential drugs in the public health system. This could be through adoption of a graded essential medicine list (EML), transparent medicine procurement, efficient distribution and adequate budgetary outlay. It recommends that the medicine policy should also promote rational medicine use in the private sector and the health department should prepare a “State Medicine Formulary” based on the health needs of the people of the state. The medicine formulary should be supplied free of cost to all Govt. hospitals and at subsidized rates to the private hospitals. Regular updating and revision of the formulary should be ensured. Treatment protocols for common diseases should be prepared and made available to medical professionals. State Govts should take steps to decentralize the health services by giving control to Panchayati Raj Institutions (PRIs) and Govt. hospitals up to the district level. Enough funds from the plan and non plan amount should be devolved to the PRIs. The local bodies should be given the responsibility to formulate and implement health projects within the overall frame of the health policy of the state.2
Decentralization must devolve authority and power to States and Districts but also to the local bodies. This has occurred only in Kerala. Able leadership and governance connotes the ability to properly plan, adequately budget for, timely implement, properly manage, effectively monitor, sincerely review and willingly accept responsibility for the decisions taken. The strategy of the “big bang” approach of Kerala where, in one sweep, functions, powers and responsibilities were transferred, has proved to be successful as compared to other states where devolution has been incremental, halting and sporadic.3
In the past policy discussions about health care usually focussed national level. In recent years, there has been increased focus at the state level, as it is responsible for actual delivery of health services. States are thought to have a free hand in designing and implementing policies that are specific to own needs and circumstances. Analysis shows that policy makers have to be cognizant of state level determinants in order to design effective policies to improve immunization rates in the country. Given the fact that vaccine preventable diseases loom large in terms of childhood morbidity and mortality, it is critical that financial and material resources be directed at the most appropriate level based on identified inadequacies.4
India’s health system was designed when expectations were different. India has undergone transition in demographic, epidemiologic and social health. Disparities in life expectancy, disease, access to health care and protection from financial risks have increased. The previous approach to national health policies and programmes is now out dated. By analyzing inter and intra state differences, the content of national health policy needs to be more accommodative to specificities of states and districts. ‘Splitting’ of India’s health policy at the state level would better address their health problems, and would open the way to innovation and accountability. States need to focus on improving the quality and access of essential public health services, and empowering communities to take ownership. The central Govt. needs to support and facilitate states and districts to develop critical capacities rather than manage their programmes. More explicit and comprehensive state policies and strategies in health are needed now more than ever. States that are early in the health transition need to focus more attention and resources on addressing the health transition. Much of this would need to be through strengthened public sector programmes, and soliciting greater collaboration with private sector.5
Examination of plans and policy indicates the gap between the rhetoric and reality and the framework responsible for this. The spirit of primary health care has been reduced to mere primary level. The multisectoral approach that is needed and the intersectoral linkages that are essential for a vibrant, throbbing health system have been unfortunately missing. The outline of health plan documents and implementation has been incremental rather than holistic. It is important to question whether it is only the low investment in health that is the main reason for the present status of the health system or is it also to do with the framework, design and approach within which the policies have been planned.
Technological advances, investment and good policies are of no use if the system lacks leadership, direction and integrity. Unless all stakeholders are motivated by values of humane compassion for the ailing, sense of equality and dignity; the health system will continue to reflect the cement and mortar issues of the expanding medical and medicine industry, which can, in the absence of the guiding hand of the state, degrade human suffering into an opportunity for profiteering.
It is desirable that there should be one national policy addressing regional concerns of different states in country. It remains to be seen if this will work because health is a state subject in India and it is for the individual states to decide how best they can procure, store and distribute medicines on the basis of their available distribution channels and infrastructure, their topography; how best they can enforce their medicine related laws in their region; what type of medicines they should include in their EML on the basis of ADR profile of their region; and how best they can enhance the affordability of medicines on the basis
of available manufacturing capacities. Regional variations persist and so do regional programmes, hence the need for regional, state-specific medicine policies.
REFERENCES
1. Roy Chaudhury R, Parameswar R, Gupta U, Sharma S, Tekur U, Bapna JS, Gurbani NK. Quality Medicines for the Poor: Experience of Delhi Programme on Rational Use of Drugs (1995-2000). Health Policy & Planning 2005, 20: 124-136.
2. National Human Rights Commission, New Delhi. Recommendations of National Action Plan to operationalize the right to healthcare.
3. Financing and Delivery of Healthcare Services in India”: A report by the National Commission on Macroeconomics and Health. Background Papers of the National Commission on Macroeconomics and Health. Ministry Of Health And Family Welfare Government Of India, 2005.
4. Melissa Gatchell, Amardeep Thind, Fred Hagigi. Informing state-level health policy in India: The case of childhood immunizations in Maharashtra and Bihar. Acta Pædiatrica 2008, 97, pp. 124–126
5. David H, Peters,K , Sujatha Rao and Robert Fryatt. Lumping and splitting: the health policy agenda. Health Policy and Planning 2003. 18(3): 249–260
Keeping with above concerns, each state frames state specific medicine policy that addresses key issues related to the availability of safe and effective medicines at affordable prices as well as to their rational prescribing, improved distribution and sale in accordance with the existing laws.
Many states like Karnataka, Kerala, West Bengal, Himachal Pradesh, Punjab, Delhi, Chattisgarh, Madhya Pradesh, Orissa etc; have their own state drug and health policy but not all states. Hence there is need to enhance the level of awareness about having such a policy and to make the decision makers realize the urgency to take notice of the need.
India’s health care delivery system is divided in four levels: rural health centres, district hospitals, tertiary care hospitals and teaching hospitals. Pharmaceutical policy in India is perceived primarily as an industrial policy rather than a health policy. Under the Constitution of India both the Central Govt and the States have concurrent duties for drug control, for safety, quality and efficacy. Public expenditure on drugs has generally remained low at about US$1 per capita. The public has to largely depend on out-of-pocket expenditure, purchasing medicines from chemists or paying private practitioners. While nearly 75% of health care, including medicines, is obtained from private sources, marginalised populations living in remote rural areas largely depend on public facilities. Considering the diverse nature of India, its population size and socio-cultural characteristics, and health care being state matter, there is need for framing drug and health policies at state level in order to cater to the local requirements and ensure proper implementation of Govt. programmes at the grass root level 1.
National Human Rights Commission (NHRC) recommends the adoption of a State essential drug policy in every state that ensures full availability of essential drugs in the public health system. This could be through adoption of a graded essential medicine list (EML), transparent medicine procurement, efficient distribution and adequate budgetary outlay. It recommends that the medicine policy should also promote rational medicine use in the private sector and the health department should prepare a “State Medicine Formulary” based on the health needs of the people of the state. The medicine formulary should be supplied free of cost to all Govt. hospitals and at subsidized rates to the private hospitals. Regular updating and revision of the formulary should be ensured. Treatment protocols for common diseases should be prepared and made available to medical professionals. State Govts should take steps to decentralize the health services by giving control to Panchayati Raj Institutions (PRIs) and Govt. hospitals up to the district level. Enough funds from the plan and non plan amount should be devolved to the PRIs. The local bodies should be given the responsibility to formulate and implement health projects within the overall frame of the health policy of the state.2
Decentralization must devolve authority and power to States and Districts but also to the local bodies. This has occurred only in Kerala. Able leadership and governance connotes the ability to properly plan, adequately budget for, timely implement, properly manage, effectively monitor, sincerely review and willingly accept responsibility for the decisions taken. The strategy of the “big bang” approach of Kerala where, in one sweep, functions, powers and responsibilities were transferred, has proved to be successful as compared to other states where devolution has been incremental, halting and sporadic.3
In the past policy discussions about health care usually focussed national level. In recent years, there has been increased focus at the state level, as it is responsible for actual delivery of health services. States are thought to have a free hand in designing and implementing policies that are specific to own needs and circumstances. Analysis shows that policy makers have to be cognizant of state level determinants in order to design effective policies to improve immunization rates in the country. Given the fact that vaccine preventable diseases loom large in terms of childhood morbidity and mortality, it is critical that financial and material resources be directed at the most appropriate level based on identified inadequacies.4
India’s health system was designed when expectations were different. India has undergone transition in demographic, epidemiologic and social health. Disparities in life expectancy, disease, access to health care and protection from financial risks have increased. The previous approach to national health policies and programmes is now out dated. By analyzing inter and intra state differences, the content of national health policy needs to be more accommodative to specificities of states and districts. ‘Splitting’ of India’s health policy at the state level would better address their health problems, and would open the way to innovation and accountability. States need to focus on improving the quality and access of essential public health services, and empowering communities to take ownership. The central Govt. needs to support and facilitate states and districts to develop critical capacities rather than manage their programmes. More explicit and comprehensive state policies and strategies in health are needed now more than ever. States that are early in the health transition need to focus more attention and resources on addressing the health transition. Much of this would need to be through strengthened public sector programmes, and soliciting greater collaboration with private sector.5
Examination of plans and policy indicates the gap between the rhetoric and reality and the framework responsible for this. The spirit of primary health care has been reduced to mere primary level. The multisectoral approach that is needed and the intersectoral linkages that are essential for a vibrant, throbbing health system have been unfortunately missing. The outline of health plan documents and implementation has been incremental rather than holistic. It is important to question whether it is only the low investment in health that is the main reason for the present status of the health system or is it also to do with the framework, design and approach within which the policies have been planned.
Technological advances, investment and good policies are of no use if the system lacks leadership, direction and integrity. Unless all stakeholders are motivated by values of humane compassion for the ailing, sense of equality and dignity; the health system will continue to reflect the cement and mortar issues of the expanding medical and medicine industry, which can, in the absence of the guiding hand of the state, degrade human suffering into an opportunity for profiteering.
It is desirable that there should be one national policy addressing regional concerns of different states in country. It remains to be seen if this will work because health is a state subject in India and it is for the individual states to decide how best they can procure, store and distribute medicines on the basis of their available distribution channels and infrastructure, their topography; how best they can enforce their medicine related laws in their region; what type of medicines they should include in their EML on the basis of ADR profile of their region; and how best they can enhance the affordability of medicines on the basis
of available manufacturing capacities. Regional variations persist and so do regional programmes, hence the need for regional, state-specific medicine policies.
REFERENCES
1. Roy Chaudhury R, Parameswar R, Gupta U, Sharma S, Tekur U, Bapna JS, Gurbani NK. Quality Medicines for the Poor: Experience of Delhi Programme on Rational Use of Drugs (1995-2000). Health Policy & Planning 2005, 20: 124-136.
2. National Human Rights Commission, New Delhi. Recommendations of National Action Plan to operationalize the right to healthcare.
3. Financing and Delivery of Healthcare Services in India”: A report by the National Commission on Macroeconomics and Health. Background Papers of the National Commission on Macroeconomics and Health. Ministry Of Health And Family Welfare Government Of India, 2005.
4. Melissa Gatchell, Amardeep Thind, Fred Hagigi. Informing state-level health policy in India: The case of childhood immunizations in Maharashtra and Bihar. Acta Pædiatrica 2008, 97, pp. 124–126
5. David H, Peters,K , Sujatha Rao and Robert Fryatt. Lumping and splitting: the health policy agenda. Health Policy and Planning 2003. 18(3): 249–260
Challenges in healthcare sector before UPA govt of India
Two months have passed since the new Govt under the Prime Ministership of Dr. Manmohan Singh took over the reins in India. The United Progressive Alliance (UPA), finds itself in a position in which no previous Indian Govt since the Narasimha Rao govt. of 1999 has been - a position from which it can consolidate the policies it embarked upon in 2004. It has the right majority in the Parliament to ensure it does not need to make as many compromises as coalition Govts usually do. Unlike last time, there are no constraints of common minimum programme. The congress has the manifesto to follow. Quick reading of the election manifesto shows that it emphasizes continuity and the kind of radical reforms that the market likes. The Indian pharma industry welcomed the UPA's return to power with a decisive mandate reflecting formation of a stable Govt to carry forward economic reforms, with expectations that the Govt would frame policies that will support the sector.
Health is one of the directive principles enshrined in the Indian Constitution. Although Article 21 of the Constitution requires the State to ensure the health and nutritional well being of all people, the Govt has a substantial technical and financial role in it.
The Indian healthcare sector constitutes:
• Medical care providers: physicians, specialist clinics, nursing homes and hospitals
• Diagnostic service centers and pathology laboratories,
• Medical equipment manufacturers,
• Contract research organizations (CRO's),
• Pharmaceutical manufacturers, distributors and dealers
• Third party support service providers (catering, laundry)
Before independence of India, the health care sector was in dismal condition with high morbidity and mortality rates and prevalence of infectious diseases. Since then India has worked continuously to improve Primary Health Care and its health care system. Considerable progress has been made in expanding the public system and reducing the burden of disease. But the Govt funded facilities are not matching the growing population demand in primary, secondary or tertiary care. Post Liberalization, in the 1980's the entry norms for private players in the health services industry were relaxed and now the private healthcare facilities are owned and run by for profit companies, non-profit or charitable organizations.
The healthcare industry has emerged as one of the most challenging sector in India with estimated revenue of about $ 30 billion (FY 2005) constituting 5% of the GDP. The Indian health services sector is estimated to be around Rs. 750 billion with hospitals accounting for more than half of this. The sector had a growth of over 12% p.a. in the past four years and is estimated to grow by 170% by 2012. Though the private sector has also been equally responsible in bringing about the desired changes in the health industry, the health sector performance requires much improvement in comparison with other emerging economies. Deficiencies persist with respect to access, affordability, efficiency, quality and effectiveness, despite the high level of overall private and public expenditure on health. More than 26% of population living below the poverty line still finds it difficult to have an affordable access to quality medicines and healthcare facilities. A senior official of the Department of Pharmaceuticals, GOI quoting WHO figures disclosed that only 35% of our population has access to healthcare, mostly from private doctors and hospitals and about 80% our total health spending is on medicines.
In 1978, India pledged along with other WHO member Nations, 'Health for All by the Year 2000' at Alma-Ata; and in the same year signed the International Covenant for Economic, Social and Cultural Rights, under which the State is obliged to achieve the highest attainable standard of health. However the health scenario in India despite growth continues to be abysmal. Alarming and appalling healthcare scenario in India is depicted by the facts that annually 22 lakh infants and children die from preventable illnesses; 1 lakh mothers die during child birth, 5 lakh people die of Tuberculosis. Diarrhea and Malaria continue to be killers while 5 million people are suffering from HIV/AIDS. Many self-help groups believe that since 1990s, the public health system has been collapsing and the private health sector has flourished at the cost of the public health sector because health policy in India has shifted its focus from being a comprehensive universal healthcare system as defined by the Bhore Committee (1946) to a selective and targeted programme based healthcare policy with the public domain being confined to family planning, immunization, selected disease surveillance, medical education and research. The larger outpatient care is almost a private health sector monopoly and the hospital sector is increasingly being surrendered to the market. Reforms of the 90s have created a trajectory of public health spending that shows a downward trend both in terms of share of the Govt's budget as well as a proportion of the Gross Domestic Product.
There have of course been reservations about the Govt budget's outlay on health being only 15% higher than last year. A steady annual increase of 35% is needed over several years to raise public health spending from the present paltry 0.9% of GDP to the National Common Minimum Plans target of 2 to 3%. Another requirement is greater decentralization of the public health delivery system. Health infrastructure is marked by great disparity between rural and urban areas. Most secondary and tertiary health facilities are available in urban and tier-II cities. There is a need to incentivise building up health infrastructure in rural areas.
Recommendations for the UPA Govt.
1. New UPA Govt must fulfill its promise of amending the Drugs and Cosmetics Act so as to award exemplary and deterrent punishments to those dealing with counterfeit medicines.
2. Proposal for constitution of National Drug Authority was first mooted in the Drug Policy of 1994, then came the idea of "Central Drug Authority" (CDA) and then in recent draft of National Pharmaceutical Policy of 2005 there was talk of "National Authority for Drugs and Therapeutics" which sought integration of NPPA, DCGI and CDSCO into one body. Govt. must establish CDA now as early as possible.
3. Govt. must frame a comprehensive, patient-friendly National Pharmaceutical Policy in consensus with the recommendations of various expert committees / commissions without any further dilly-dallying and meaningless meetings.
4. It is high time that the new Govt tightens its noose in regard to price regulation and control of medicines. Erring companies need to be taken to task and overcharged dues need to be recovered, which should be spent on healthcare schemes for poor and downtrodden. All essential medicines should be brought under Price Control commensurate to the ruling of Supreme Court in 2003 and any overcharging by pharmaceutical companies in future should be viewed very seriously.
5. Sale of medicines as food/dietary supplements should not be allowed because not only do the companies in question manage to sell the same product > five times higher price but also manage to escape from attracting legal and penal provisions as provided under Drugs and Cosmetics Act. Present Govt. at the centre needs to bring a tough legislative provision to curb this malpractice and besides punishing the guilty, it should also recover the dues on account of such dubious sale by them in the past. Govt. must seriously think about enacting Criminal Profiteering Act in India to curb such kind of malpractices. This way crores of rupees can be recovered from such erring companies that can be utilized for welfare and healthcare measures of poor sects of the society.
6. NPPA must vigorously monitor the prices of medicines and take serious cognizance of any undue hike. 10% monitoring window should be effectively started. Price monitoring window should be commensurate to the current inflation index of the country.
7. For making available anti-cancer and anti-HIV/AIDS medicines at reasonable prices, Govt. must evolve the public-private partnership programme with the concerned manufacturers and cancer hospitals in the country.
8. Commitments made by previous UPA regime towards Pharmaceutical Research and Development in the country need to be fulfilled. It had established a Pharmaceutical Research and Development Support Fund (PRDSF) having a corpus of Rs. 150 crores (where only interest income is available for spending) and is utilized for funding R&D projects of research institutions and industry in the country. Govt. had duly acknowledged that this amount is by no measures adequate to meet the present day and the emerging requirements of this sector and that this fund would be sufficiently augmented. It was also decided to convert it into an annual grant of Rs. 150 crores, so that thereafter it could be suitably increased further in a phased manner over a period of next five years. Under this fund priority had to be given for R&D in case of diseases which are endemic to India like malaria, tuberculosis, hepatitis-B, leishmania, HIV/AIDS etc. The programme has stagnated at where it was in 2005 and no substantial headway has been made. New dispensation should take up this matter on priority so as to boost pharmaceutical and disease research activities in the country.
9. There is need for a strong first-level care with strong secondary- and tertiary-level care linked to it. New UPA Govt. must take bold initiatives for an integration of preventive, promotive, curative and rehabilitative health services which have to be made accessible and available to the people. Healthcare delivery has to be guided by the principles of universality, comprehensiveness and equity.
10. It is truly a very sad fact that wherever our National Health Policy makes a mention of the health personnel, it mentions only about doctors and nurses, very blissfully and unfortunately ignoring the Pharmacists, who otherwise are an integral and important component of the medical team and whose significant role in healthcare delivery can be ignored only by the ignorant.
11. The national health policy was framed in 2002 and unfortunately no revision or modification has been carried out since then even after seven years after its promulgation. Considering the outbreak of newer diseases, ever changing population characteristics, morbidity and mortality and demography, our National Health Policy direly requires a prompt revision by our new Govt.
12. UPA Govt announced several schemes for making medical and healthcare facilities accessible and affordable to poor people living in far flung areas of the country like National Rural Health Mission, National Illness Assistance Fund, Rashtriya Swasthya Bima Yojana etc. Mute question staring in the face of the Govt is whether these schemes are implemented in letter and spirit and whether their benefits are reaching to the target group or going into the fat bellies of huge armies of sarkari babus and politicians. Union Health Minister recently pledged to ensure full implementation of these schemes by reviewing their progress every six months in every state, by visiting every state twice a year and by holding review meetings with Chief Ministers and Health Ministers. But will these measures suffice to check age old pilferage and diversion tactics of corrupt officials? Whole system has to be shaken up vigorously to ensure their implementation in true sense of the word and accountability has to be monitored, recorded, ensured and legally enforced at every level in the supply chain.
13. Erstwhile Health Minister Ambumani Ramados had made a promise to launch National Urban Health Mission in the country that was supposed to provide insurance cover to the millions of slum dwellers in urban areas with an aim of giving them basic medical facilities. The new Health Minister must take steps to launch this scheme on priority.
14. In respect of Promotion of Generics, Task Force set up by the Govt has strongly recommended that the public procurement and distribution of medicines through the public health system should mainly be for generic drugs, Quality certification may be provided free to dedicated generic manufacturers and there should be no control on price or distribution margins specified for generics. Four years have passed since the Task Force submitted its report but unfortunately no ground change is noticeable in terms of implementation of its recommendations. It is time for Govt. to shun inaction and indecisiveness and implement recommendations of various expert groups.
15. The much hyped plan to extend health care facilities by Employees State Insurance Corporation (ESIC) hospitals to BPL families covered under the Rashtriya Swasthya Bima Yojana is yet to be implemented. An ordinance by the labour ministry amending the Employees State Insurance Act has lapsed. The ordinance issued in July last year has expired as it could not be ratified by the Parliament. Challenge for new Govt. is to bring the ordinance back into force and ensure medical and healthcare facilities to BPL families at 144 ESIC hospitals of the country free of cost.
16. In India, > 53% children (67 million) under five years, live without basic healthcare facilities. This means that India alone accounts for about one-third of all children in the world aged below five who do not get basic healthcare. It also means that poor children in India, along with those in Brazil and Egypt, are three times more likely to die before their fifth birthday than children in other parts of the world. 66% of the poorest children in India receive no or minimal healthcare, the number stands at 31% of well-off children, who are not covered. While India has cut its overall child mortality rate by 34% since 1990, the survival gap between girls and boys has widened. New dispensation at the centre must take adequate measures to rectify this dismal scenario.
17. The RCH programme emphasizes improving access to skilled care and emergency obstetric care, as also coverage and quality of antenatal care and increasing the coverage of post partum care. The Govt has introduced the “Janani Suraksha Yojana”, which is a modification of the National Maternity Benefit Scheme that provides comprehensive medical care during pregnancy, child birth and post natal care and thereby improve the level of institutional deliveries in low performing States to reduce maternal mortality. Effective implementation of this scheme is required.
18. Under the Capacity Building Project through World Bank, assistance has been provided to upgrade testing facilities and to establish new drug testing laboratories so as to enhance the capacity of the laboratories to test large number of samples. Under this project 23 States and 6 Central Drug Laboratories had to be strengthened through renovations, extensions and equipments. However the present status of progress made in this World Bank assisted project is not well known. Therefore GOI must take up the up gradation of state and central drug testing laboratories on priority to enhance the capacity to test drugs which shall in turn help in detection of spurious drugs.
Health is one of the directive principles enshrined in the Indian Constitution. Although Article 21 of the Constitution requires the State to ensure the health and nutritional well being of all people, the Govt has a substantial technical and financial role in it.
The Indian healthcare sector constitutes:
• Medical care providers: physicians, specialist clinics, nursing homes and hospitals
• Diagnostic service centers and pathology laboratories,
• Medical equipment manufacturers,
• Contract research organizations (CRO's),
• Pharmaceutical manufacturers, distributors and dealers
• Third party support service providers (catering, laundry)
Before independence of India, the health care sector was in dismal condition with high morbidity and mortality rates and prevalence of infectious diseases. Since then India has worked continuously to improve Primary Health Care and its health care system. Considerable progress has been made in expanding the public system and reducing the burden of disease. But the Govt funded facilities are not matching the growing population demand in primary, secondary or tertiary care. Post Liberalization, in the 1980's the entry norms for private players in the health services industry were relaxed and now the private healthcare facilities are owned and run by for profit companies, non-profit or charitable organizations.
The healthcare industry has emerged as one of the most challenging sector in India with estimated revenue of about $ 30 billion (FY 2005) constituting 5% of the GDP. The Indian health services sector is estimated to be around Rs. 750 billion with hospitals accounting for more than half of this. The sector had a growth of over 12% p.a. in the past four years and is estimated to grow by 170% by 2012. Though the private sector has also been equally responsible in bringing about the desired changes in the health industry, the health sector performance requires much improvement in comparison with other emerging economies. Deficiencies persist with respect to access, affordability, efficiency, quality and effectiveness, despite the high level of overall private and public expenditure on health. More than 26% of population living below the poverty line still finds it difficult to have an affordable access to quality medicines and healthcare facilities. A senior official of the Department of Pharmaceuticals, GOI quoting WHO figures disclosed that only 35% of our population has access to healthcare, mostly from private doctors and hospitals and about 80% our total health spending is on medicines.
In 1978, India pledged along with other WHO member Nations, 'Health for All by the Year 2000' at Alma-Ata; and in the same year signed the International Covenant for Economic, Social and Cultural Rights, under which the State is obliged to achieve the highest attainable standard of health. However the health scenario in India despite growth continues to be abysmal. Alarming and appalling healthcare scenario in India is depicted by the facts that annually 22 lakh infants and children die from preventable illnesses; 1 lakh mothers die during child birth, 5 lakh people die of Tuberculosis. Diarrhea and Malaria continue to be killers while 5 million people are suffering from HIV/AIDS. Many self-help groups believe that since 1990s, the public health system has been collapsing and the private health sector has flourished at the cost of the public health sector because health policy in India has shifted its focus from being a comprehensive universal healthcare system as defined by the Bhore Committee (1946) to a selective and targeted programme based healthcare policy with the public domain being confined to family planning, immunization, selected disease surveillance, medical education and research. The larger outpatient care is almost a private health sector monopoly and the hospital sector is increasingly being surrendered to the market. Reforms of the 90s have created a trajectory of public health spending that shows a downward trend both in terms of share of the Govt's budget as well as a proportion of the Gross Domestic Product.
There have of course been reservations about the Govt budget's outlay on health being only 15% higher than last year. A steady annual increase of 35% is needed over several years to raise public health spending from the present paltry 0.9% of GDP to the National Common Minimum Plans target of 2 to 3%. Another requirement is greater decentralization of the public health delivery system. Health infrastructure is marked by great disparity between rural and urban areas. Most secondary and tertiary health facilities are available in urban and tier-II cities. There is a need to incentivise building up health infrastructure in rural areas.
Recommendations for the UPA Govt.
1. New UPA Govt must fulfill its promise of amending the Drugs and Cosmetics Act so as to award exemplary and deterrent punishments to those dealing with counterfeit medicines.
2. Proposal for constitution of National Drug Authority was first mooted in the Drug Policy of 1994, then came the idea of "Central Drug Authority" (CDA) and then in recent draft of National Pharmaceutical Policy of 2005 there was talk of "National Authority for Drugs and Therapeutics" which sought integration of NPPA, DCGI and CDSCO into one body. Govt. must establish CDA now as early as possible.
3. Govt. must frame a comprehensive, patient-friendly National Pharmaceutical Policy in consensus with the recommendations of various expert committees / commissions without any further dilly-dallying and meaningless meetings.
4. It is high time that the new Govt tightens its noose in regard to price regulation and control of medicines. Erring companies need to be taken to task and overcharged dues need to be recovered, which should be spent on healthcare schemes for poor and downtrodden. All essential medicines should be brought under Price Control commensurate to the ruling of Supreme Court in 2003 and any overcharging by pharmaceutical companies in future should be viewed very seriously.
5. Sale of medicines as food/dietary supplements should not be allowed because not only do the companies in question manage to sell the same product > five times higher price but also manage to escape from attracting legal and penal provisions as provided under Drugs and Cosmetics Act. Present Govt. at the centre needs to bring a tough legislative provision to curb this malpractice and besides punishing the guilty, it should also recover the dues on account of such dubious sale by them in the past. Govt. must seriously think about enacting Criminal Profiteering Act in India to curb such kind of malpractices. This way crores of rupees can be recovered from such erring companies that can be utilized for welfare and healthcare measures of poor sects of the society.
6. NPPA must vigorously monitor the prices of medicines and take serious cognizance of any undue hike. 10% monitoring window should be effectively started. Price monitoring window should be commensurate to the current inflation index of the country.
7. For making available anti-cancer and anti-HIV/AIDS medicines at reasonable prices, Govt. must evolve the public-private partnership programme with the concerned manufacturers and cancer hospitals in the country.
8. Commitments made by previous UPA regime towards Pharmaceutical Research and Development in the country need to be fulfilled. It had established a Pharmaceutical Research and Development Support Fund (PRDSF) having a corpus of Rs. 150 crores (where only interest income is available for spending) and is utilized for funding R&D projects of research institutions and industry in the country. Govt. had duly acknowledged that this amount is by no measures adequate to meet the present day and the emerging requirements of this sector and that this fund would be sufficiently augmented. It was also decided to convert it into an annual grant of Rs. 150 crores, so that thereafter it could be suitably increased further in a phased manner over a period of next five years. Under this fund priority had to be given for R&D in case of diseases which are endemic to India like malaria, tuberculosis, hepatitis-B, leishmania, HIV/AIDS etc. The programme has stagnated at where it was in 2005 and no substantial headway has been made. New dispensation should take up this matter on priority so as to boost pharmaceutical and disease research activities in the country.
9. There is need for a strong first-level care with strong secondary- and tertiary-level care linked to it. New UPA Govt. must take bold initiatives for an integration of preventive, promotive, curative and rehabilitative health services which have to be made accessible and available to the people. Healthcare delivery has to be guided by the principles of universality, comprehensiveness and equity.
10. It is truly a very sad fact that wherever our National Health Policy makes a mention of the health personnel, it mentions only about doctors and nurses, very blissfully and unfortunately ignoring the Pharmacists, who otherwise are an integral and important component of the medical team and whose significant role in healthcare delivery can be ignored only by the ignorant.
11. The national health policy was framed in 2002 and unfortunately no revision or modification has been carried out since then even after seven years after its promulgation. Considering the outbreak of newer diseases, ever changing population characteristics, morbidity and mortality and demography, our National Health Policy direly requires a prompt revision by our new Govt.
12. UPA Govt announced several schemes for making medical and healthcare facilities accessible and affordable to poor people living in far flung areas of the country like National Rural Health Mission, National Illness Assistance Fund, Rashtriya Swasthya Bima Yojana etc. Mute question staring in the face of the Govt is whether these schemes are implemented in letter and spirit and whether their benefits are reaching to the target group or going into the fat bellies of huge armies of sarkari babus and politicians. Union Health Minister recently pledged to ensure full implementation of these schemes by reviewing their progress every six months in every state, by visiting every state twice a year and by holding review meetings with Chief Ministers and Health Ministers. But will these measures suffice to check age old pilferage and diversion tactics of corrupt officials? Whole system has to be shaken up vigorously to ensure their implementation in true sense of the word and accountability has to be monitored, recorded, ensured and legally enforced at every level in the supply chain.
13. Erstwhile Health Minister Ambumani Ramados had made a promise to launch National Urban Health Mission in the country that was supposed to provide insurance cover to the millions of slum dwellers in urban areas with an aim of giving them basic medical facilities. The new Health Minister must take steps to launch this scheme on priority.
14. In respect of Promotion of Generics, Task Force set up by the Govt has strongly recommended that the public procurement and distribution of medicines through the public health system should mainly be for generic drugs, Quality certification may be provided free to dedicated generic manufacturers and there should be no control on price or distribution margins specified for generics. Four years have passed since the Task Force submitted its report but unfortunately no ground change is noticeable in terms of implementation of its recommendations. It is time for Govt. to shun inaction and indecisiveness and implement recommendations of various expert groups.
15. The much hyped plan to extend health care facilities by Employees State Insurance Corporation (ESIC) hospitals to BPL families covered under the Rashtriya Swasthya Bima Yojana is yet to be implemented. An ordinance by the labour ministry amending the Employees State Insurance Act has lapsed. The ordinance issued in July last year has expired as it could not be ratified by the Parliament. Challenge for new Govt. is to bring the ordinance back into force and ensure medical and healthcare facilities to BPL families at 144 ESIC hospitals of the country free of cost.
16. In India, > 53% children (67 million) under five years, live without basic healthcare facilities. This means that India alone accounts for about one-third of all children in the world aged below five who do not get basic healthcare. It also means that poor children in India, along with those in Brazil and Egypt, are three times more likely to die before their fifth birthday than children in other parts of the world. 66% of the poorest children in India receive no or minimal healthcare, the number stands at 31% of well-off children, who are not covered. While India has cut its overall child mortality rate by 34% since 1990, the survival gap between girls and boys has widened. New dispensation at the centre must take adequate measures to rectify this dismal scenario.
17. The RCH programme emphasizes improving access to skilled care and emergency obstetric care, as also coverage and quality of antenatal care and increasing the coverage of post partum care. The Govt has introduced the “Janani Suraksha Yojana”, which is a modification of the National Maternity Benefit Scheme that provides comprehensive medical care during pregnancy, child birth and post natal care and thereby improve the level of institutional deliveries in low performing States to reduce maternal mortality. Effective implementation of this scheme is required.
18. Under the Capacity Building Project through World Bank, assistance has been provided to upgrade testing facilities and to establish new drug testing laboratories so as to enhance the capacity of the laboratories to test large number of samples. Under this project 23 States and 6 Central Drug Laboratories had to be strengthened through renovations, extensions and equipments. However the present status of progress made in this World Bank assisted project is not well known. Therefore GOI must take up the up gradation of state and central drug testing laboratories on priority to enhance the capacity to test drugs which shall in turn help in detection of spurious drugs.
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