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.
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