Approved Drug Policy of Jammu and Kashmir - A Review

After sixty years of inaction, government of Jammu and Kashmir finally approved a draft drug policy for the state. Draft has been approved in a meeting of the state cabinet under the chairmanship of Chief Minister on January, 12^th, 2012 and is now all set to be placed in the forthcoming budget session of the legislative assembly. Draft of the drug policy was prepared by the govt. of JandK in 2009 but was grossly lacking in as many as twenty five highly significant areas. Draft had specified no policy for spurious drugs, against drug addiction, for drug licensing, for unwanted drug withdrawal and disposal, for unethical promotion and prescribing practices of drugs, for drug pricing, in-house Quality Control testing etc. It was only after a committee framed by the Civil Society Forum (CSF) Kashmir led by this author had a four-hour long marathon meeting with several senior functionaries of the health department including Commissioner-Secretary Health on November 2^nd, 2011, that some of these issues were addressed and appropriate remedial measures included in the draft. This contribution of CSF has been acknowledged in the memo prepared for the cabinet. At first, govt. officials were extremely reluctant to make any changes in the draft but finally on persistent motivation and sound explanation provided by CSF team, Commissioner-Secretary Health promised to include most of the suggestions.

SELECTION OF ESSENTIAL DRUGS:

Draft Drug Policy approved by the cabinet of ministers in JandK envisages that the Department of Health and Medical Education shall appoint an Expert Committee known as the State Drug Committee which would be responsible for initially preparing and subsequently updating the essential drug list every two years for the hospitals in public sector.  The Committee will comprise of Clinicians, Pharmacologists, Microbiologists, qualified Pharmacists and independent experts in the field besides senior functionaries of the Department like the Principals of Medical and Dental Colleges, Directors of Health Services, Controller of Drug and Food Control Organization etc. The Committee shall be headed by the senior-most Principal of Government Medical Colleges in the State. Further a separate drug committee with appropriate composition would be constituted in respect of drugs pertaining to Indian Systems of Medicine. The drugs selected by this committee shall be identified and listed by their generic names or International Non-proprietary Names (INN) only.  The State essential drug list will be subsequently categorized according to the levels of health care facilities like primary, secondary and tertiary and will be revised after every two years so as to reflect therapeutic advances and changes in cost, resistance pattern and public health relevance.

However there is one discrepancy in this key feature of the approved policy. Memorandum for approval of drug policy for JandK prepared for submission to the cabinet by the Commissioner/Secretary to Government, Health and Medical Education Department clearly reads at S.No. 8, page 4 that “two working groups, one each for Jammu and Kashmir division were constituted under the chairmanship of the respective principals of Government Medical Colleges to prepare a draft drug policy besides a state level committee under the chairmanship of then Commissioner/Secretary to Government, Health and Medical Education Department with members from each division to finalize the draft drug policy for the state. Memo reads that these working groups also prepared a draft State Essential Drugs List and Complementary Drugs List. This Essential Drugs List comprised of 383 drugs.” 

Pertinently, Civil Society Forum (CSF) Kashmir in its meeting with senior functionaries of the health department had pointed out that since the draft drug policy of 2009 envisaged that state essential drug list will be revised after every two years so as to reflect therapeutic advances and changes in cost, resistance pattern and public health relevance and given the fact that two years have already passed eversince state essential drug list appended to the draft drug policy 2009 was prepared, a new state essential drugs list must be prepared in tune with National List of Essential Medicines (NLEM), 2011 for the purpose of this policy. However it was not suggested that EDL prepared by the experts keeping in view local requirements of the state should altogether be replaced by the NLEM 2011. Consequently NLEM, 2011 appended with the approved drug policy is the one that caters to the whole country in general and not to the JandK state in particular. It would have been more pertinent to revise the state EDL in consonance with diseases endemic to this region and the local needs of our hospitals.

PROCUREMENT OF ESSENTIAL DRUGS:

Owing to the friction between Health Ministry and the Ministry of Medical Education in the state, the idea of having an autonomous corporation on the pattern of Tamil Nadu Medical Supplies Corporation (TNMSC) as was mooted in the draft drug policy of 2009 has been skipped in the final approved draft. Unrevised draft had endorsed that the drugs included in the essential drug list shall be centrally procured through an autonomous, transparent, accountable and free from constraints mechanism on the pattern of TNMSC which has achieved unprecedented success in ensuring timely availability of quality drugs and has therefore been recommended to be adopted for procurement of drugs, not only by the Government of India but by the World Health Organization too. Unrevised draft had envisioned that the procurement, storage and transportation becomes easier, more transparent and more accountable when it is done through an autonomous Corporation and also reduces the tendency to invest funds in unutilized and slow moving stocks because the Corporation was expected to invest in drugs which have a good take off.  This model was believed to facilitate the minimization of stock outs and expired stocks, and ensure availability of essential drugs throughout the year as per the actual requirements of the health institutions. Under such a dispensation, the Health and Medical Education Department was supposed to advise on medicines to be procured but the decisions on procurement would have completely rested with the corporation.

Ignoring all these assertions made in the unrevised draft, state govt. has finally declared in the approved draft that the existing procurement mechanisms of drugs and supplies shall be improved with a view to ensuring timely availability of quality drugs. Approved policy also envisages to make the detection of pilferages/wastages/expired stocks easier and for this purpose, an appropriate Management Information System shall be evolved and a web-based e-procurement model developed. It reaffirms that the objective is to put in place an effective system of procurement of essential drugs by generic names to ensure timely availability, good quality and reasonable cost. However existing procurement mechanisms are too flawed and inefficient to improve so drastically overnight as required under approved drug policy provisions. Existing system has completely failed so far in keeping quality drugs available at hospital drug counters throughout the year.

As a matter of fact, provisions relating to generic drug prescribing cannot be a success or even a reality unless and until procurement procedures are very well defined in the policy. Unfortunately, dropped idea of having an autonomous corporation on the pattern of TNMSC could have helped a great deal in streamlining the drug procurement process and ensuring round the clock availability of quality generics at hospital counters. Drug policy approved by the state govt. specifies no detailed procedures for drug procurement and their quality assurance and unless that part is settled between the two squabbling ministries of Health and Medical Education, generic drug prescribing cannot work on expected lines. Selvaraj and Nabar have suggested in India Health Report 2010 that an efficient procurement supply chain is based on the fundamental principle of transparency in the process of selection and quantification of drugs and the procurement process – which includes tendering process, bid opening process, award conditions, payment mechanisms and quality control procedures. Lack of efficiency in any one of these areas can lead to sub-optimal procurement, resulting in a shortage of supply. Further it is likely to produce uncompetitive behavior among suppliers, leading to fewer choices of suppliers and higher prices of drugs. Therefore in larger public interest, govt. must decide on this issue as soon as possible so that the approved drug policy does not remain confined to the shelves of the government secretariat.

GENERIC DRUG PRESCRIBING:

There are widespread myths and misconceptions among common masses, pharmacists, chemists as well as doctors regarding generic drugs and these misgivings have only been compounded by the spate of misinformed newspaper columns against generic drug use published after clearance of the drug policy by the state cabinet. After years of research and worldwide consultation, World Health Organization (WHO) has clearly recommended generic drug prescribing as one of the core strategies to promote rational use of medicines across the globe. Percentage of medicines prescribed by their generic names is in fact one of the primary/ core drug use indicators used by WHO for assessing quality of drug utilization in any country. In fact there is a separate Department for Essential Medicines and Pharmaceutical Policies at WHO. Using an essential medicines list makes medicine management easier in all respects; procurement, storage and distribution becomes easier with fewer items; prescribing and dispensing becomes convenient for professionals if they have to know about fewer drugs and on top of all, availability and affordability of drugs to poor patients visiting government health facilities will drastically improve upon generic prescribing. Concept of Essential Drugs List as a whole is aimed at making the best use of limited resources particularly in resource-poor countries like India. Procurement of fewer drugs in larger quantities results in more price competition and economies of scale and also to better supply of drugs, rational prescribing, reduction in costs and finally to better health outcomes.

Worldwide, developing as well as developed nations are shifting to generic prescribing and this is showing phenomenal gains in every aspect of drug use, that is why more than 75% prescriptions in US and more than 50% prescriptions in UK contain generic drugs at present. However it is understandable that situation in our part of the globe is no match to that in US or UK, which results in numerous apprehensions about the success and implications of generic drug prescribing.  Even though generics have proved to be a big success everywhere else, in our part of the globe where there is large scale corruption and drug markets are poorly regulated showing little compliance with norms, enforcing genuine generic prescribing and sale is a huge challenge for the govt agencies. To address such predicaments, examples of several Indian states like Delhi, Tamil Nadu, West Bengal, Rajashthan, Himachal Pradesh, Chatisgarh, Kerala, Karnataka, Uttarakhand can be cited that have shifted to generic prescribing in govt hospitals successfully and tremendous benefits have been recorded in every aspect of drug use. Same is the case with another resource-constrained country like Bangladesh that has also made good progress in this direction. Initially there is skepticism but with effective implementation of the policy, all problems are gradually sorted out. However necessary pre-requisite is that there has to be effective and foolproof implementation of the policy by the government agencies, devoid of any corrupt practices. If proper implementation of the policy fails, generic prescribing cannot be of any help.

Ensuring high quality of generic drugs purchased by the govt. is an inherent component of the approved drug policy outlined under procurement provision. If the govt. follows standard guidelines of pre-qualification and post-qualification of suppliers and strictly adheres to the technical specifications as has successfully happened in case of Tamil Nadu Medical Supplies Corporation, there is no reason why govt. can't procure good quality drugs. However the controversy surrounding the autonomous corporation V/S procurement directorate in JandK has a potential to mar the entire spirit of the rational procurement policy.

There are concerns that generic drugs are not available in open markets and patients living in far-flung areas may face problems in refilling their prescriptions. These issues can be taken care of by the prescribing physicians who may prescribe as per the patient's short-, mid- and long-term needs so that patients are able to keep adequate stocks with them depending on their distance from the healthcare centres. Keeping in view exceptionally low cost of these drugs, it won't be a problem for the patients to purchase a few extra doses. Further all patients with common, speciality or rare diseases have to revisit their physicians for consultation when they can refill their prescriptions. Adequate number of drugs listed in state EDL will have to be kept available at all district level healthcare facilities throughout the state so that patients do not face any difficulty on account of their access and availability. Simultaneously, as per the approved drug policy, the State Essential Drug List will be categorized according to the levels of health care facilities like primary, secondary and tertiary. There are some drugs which though not listed in the essential drug list are required for specific diseases/exceptional cases. Keeping this in view, approved drug policy provides that a supplementary drug list shall be drawn by the State Drug Committee and a provision of grants not exceeding 10% of the allocated budget for drugs shall be earmarked for purchase of drugs in the supplementary drug list.

Having said that, Drug Policy is actually aimed at addressing the medication related needs of majority of population with common ailments, availing govt. health facilities. Number of formulations available in the market at present is more than 20,000 which are mostly needless. For almost all the diseases, 348 drugs are enough to cater to all drug related needs. This number is as per National List of Essential Medicines, 2011 and not as per our local needs. Apprehensions expressed by certain quarters that the generic drug prescribing in govt. hospitals will discredit prescribing physicians from exercising any choice of brands and at the same time it will empower the pharmacist to replace the prescribed generics with any generic of his own choice depending on his profit margins. Such fears can come true if the government machinery fails to make all drugs listed in the state essential drug list available in adequate quantities throughout the year at drug counters within the hospitals. However if govt. can successfully implement the drug policy provisions and never allow stock-outs within hospital pharmacies, then this won't happen. As per the inherent design of the approved drug policy, all prescriptions will be filled at hospital drug counters and none of the prescriptions whether belonging to in- or out-patients will need to be dispensed at drug stores outside the govt. hospitals. This can temporally affect the business of drug stores outside the govt. hospitals but with the passage of time, they will adapt to the changing scenario. Moreover such fears have propped up in other Indian states too when generic drug policies were implemented there, but eventually everything got streamlined on expected lines. Once an ambience of generic prescribing prevails, all hiccups and hurdles will be overcome automatically. For the time being provision of generic prescribing of drugs is applicable only for public sector hospitals because majority of poor people visit these hospitals for treatment and that is where they need quality medicines at affordable prices. Affluent can afford to purchase branded medicines in private sector.

WARE-HOUSING AND DISTRIBUTION:

Unrevised draft of the drug policy prepared in 2009 had mentioned that the government shall establish modern warehouses at divisional and district levels under the proposed JandK Medical Supplies Corporation keeping in view the state’s topography, climatic conditions and issues of accessibility and that the capacity of warehouses/stores would be in line with the requirement to ensure constant supply of drugs to the healthcare institutions they are feeding. However surprisingly this provision has been dropped in the draft approved by the state cabinet. One fails to understand what was wrong in establishing warehouses at divisional and district levels when the govt. has decided to procure drugs centrally and then distribute to various district level hospitals.  Pertinent to mention here that Madhya Pradesh government’s centralized drug procurement policy failed on account of non-availability of adequate drug storage and transportation facilities at district level and consequently  they had to revert back to decentralized procurement in their revised drug policy of 2009. CSF’s specific suggestion that the drugs should be stored as per good storage practices and in accordance with FEFO (first-expiring-first-out) and FIFO (first-in-first-out) fashion has not been incorporated verbatim, however, approved drug policy envisages that the drugs shall be distributed under proper transportation conditions, ensuring safety and proper delivery and that the distribution will be done in an appropriate and timely manner to maintain availability throughout the State. However CSF’s suggestion that pre- and post-shipment quality control testing/analysis of drugs should be done through random sampling on all stocks has been ignored. Thankfully approved draft has incorporated CSF proposal that the proper recall and disposal procedures shall be followed as per standard guidelines.

FINANCING:

Approved draft of the drug policy envisages that the JandK government will provide allocations for procurement and supply of drugs for all types of institutions – Primary, Secondary and Tertiary and that the Department of Health and Medical Education shall be responsible for projecting the cost of drugs required from time to time. However CSF suggestion that govt. needs to specify how drug budgets will be estimated and what will be the minimum per capita per annum expenditure on drugs has not been considered.

QUALITY ASSURANCE AND REGULATION:

Draft drug policy approved by the state cabinet duly recognizes that Controller, Drugs and Food Control Organization in the State is responsible for implementing the legislation and regulations on pharmaceuticals to ensure quality, safety, efficacy of drugs and accuracy of product information and therefore said organization needs to be strengthened through a capacity building process by augmenting infrastructure, manpower and financial resources. Drug Testing Laboratories would also be strengthened by providing equipment, qualified analysts and other requirements as may be consistent with the workload. Approved drug policy has accepted CSF suggestion that average testing time and annual testing load of govt. laboratories shall be fixed for greater accountability and the rules relating to cosmetics shall be enforced and laboratories notified for their testing purpose. However following important proposals put forth by Civil Society Forum to strengthen DFCO, JandK have not been included in the approved draft:

a.      Adequate communication, transportation, accommodation, and legal assistance facilities should be provided to the inspectorate staff in all districts besides according them gazetted cadre and proper authorization for inspecting AYUSH drug stores. All provisions of Drugs and Cosmetics Act relating to AYUSH medicines listed under Chapter IV-A should be enforced.

b.      JandK Government should mobilize all necessary resources to make Drug Inspectors available at Block level rather than at tehsil level in the state.

MEASURES TO CURB SPURIOUS MEDICINES:

In regard to curbing the menace of spurious/counterfeit/sub standard/misbranded/ adulterated drugs in the state approved draft of the drug policy includes CSF suggestions that an intelligence-cum-legal cell shall be established in the office of Drug and Food Control Organization, J and K to facilitate busting of spurious drug rackets and their prompt prosecution and that the efforts shall be made to provide incentives to informers giving information about spurious drugs. It also mentions that adequate steps shall be taken to ensure proper implementation of drug regulations especially with regard to offences related to adulterated or spurious drugs. However further suggestions put forth by CSF in this regard as shown below have not been included in the approved draft:

1. Special courts shall be designated to try the cases of spurious drugs
2. Effective networking system between neighbouring states shall be developed.
3. Necessary changes in law shall be made to award severe and deterrent punishments as afforded under law to those dealing with spurious drugs, making the offences cognizable and non-bailable in the light of similar provisions in Narcotic Drugs and Psychotropic Substances Act.
4. A distance of at least 500 meters shall be maintained between two successive shops.
5. Drug sale licences shall be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. Necessary amendments shall be made in the relevant Acts to enforce this provision.
6. Preparation of dossiers of suspected dealers and manufactures shall be a perpetual exercise. Such dealers will be black-listed and their licences cancelled.
7. Manufacturers shall be encouraged to have their own anti-counterfeit drug strategies like RFID, QRC etc, better surveillance and efficient complaint handling system.
8. Effective interaction between the stakeholders i.e. industry and regulators, industry and consumers, trade and regulators and medical professional and regulators, will be developed

Further in light of the fact that several conflicting yet alarming reports about the magnitude of spurious medicines in Indian markets ranging from as low as 0.25%, as per govt. claims upto a whopping 35% as claimed by several independent groups like ASSOCHAM, CII, OECD, EC etc, it is difficult to hazard a guess about the extent of this unscrupulous trade in JandK. Therefore CSF had suggested that a statistically designed, scientifically implemented, statewide survey should be conducted by collecting samples from every nook and corner of the state and testing them for their quality and authenticity, to measure the extent of this menace in JandK state. Govt. of JandK has not deemed it worthwhile to consider and accept this proposal on the grounds that drug inspectorate of the Drug and Food Control Organization, JandK as part of their routine duties regularly lift drug samples for testing and there is no need for a separate survey in this regard. Approved draft does make a mention that the surveillance on the quality of drugs available in the market shall be maintained by collecting samples and taking further action according to law. However CSF suggestion that in-house quality control cells should be established in all hospitals where drugs lifted by random sampling should be tested for their quality has not been considered.

DRUG LICENSING POLICY:

Even though approved drug policy declares that efforts shall be made to rationalize number of drug licences and to strictly enforce the provisions of the JandK Pharmacy Act, Samvat 2011 and the rules framed thereunder, shockingly it makes no commitment that Education Regulations will be enforced in the state and thereafter further registration of unqualified people as Registered Pharmacists will be stopped that has of late turned into a non-stop nuisance in the state. Surprisingly commitment to this effect has been made in the memo for submission to the state cabinet of ministers but the same is missing in the approved draft of the drug policy making the government’s intentions doubtful since illegitimate registration of unqualified people shall continue, as per JandK Pharmacy Act unless and until Education Regulations are not enforced in the state. In this regard following suggestions put forth by the Civil Society Forum have been completely ignored.

“Central Pharmacy Act of 1948 should be enforced in the state to replace JandK Pharmacy Act 2011 (samvat) and the JandK Pharmacy Council should endeavour to constitute its executive committee and frame Pharmacy Education Regulations and implement them as soon as possible so that minimum standards can be prescribed for colleges and institutes offering diploma or degree courses in Pharmacy. This will make sure that nobody enters the profession of pharmacy without earning a legal qualification. Further the constitution and scope of JandK Pharmacy Council shall be broadened, making it all-inclusive by enrolling professionals from academia, hospitals, industry and trade as its members”. Some kind of sabotage by certain vested interests in this regard cannot be ruled out.

POLICY IN RELATION TO AYUSH DRUGS:

Approved draft provides that the regulatory laws related to quality control of AYUSH drugs shall be examined and suitable amendments in the said regulations shall be made, wherever necessary. However following additional measures suggested by CSF in respect of drugs belonging to AYUSH systems of medicine have been dropped on the pretext that a separate policy for such drugs shall be devised by the govt. in due course of time:

a.      A committee comprising of traditional health practitioners and healers, and experts in pharmacognosy, toxicology and related fields should be constituted to study and guide the various activities with respect to AYUSH drugs.

b.      The health conditions that can be treated with these traditional systems of medicine should be identified.

c.      An appropriate methodology and technology for the identification, development and production of medicinal items used by the traditional systems of medicine should be developed.

d.      Scientific studies to evaluate the quality, safety and efficacy of traditional and herbal medicines should be fostered and promoted.

e.      All practitioners of traditional medicine systems as well as the public should be encouraged to remain alert to adverse reactions to traditional and herbal medicines and to notify them to the Drug Information Centres and the nodal centre for drug information in the State.

f.        Cultivation and research of medicinal plants, should also be encouraged and promoted.

Had JandK government included these proposals, use of drugs belonging to Alternative System of Medicine would have been streamlined to a very large extent even if govt. had any plans to bring in a separate policy for such drugs.

DRUG ADVERTISEMENT AND PROMOTION:

This particular clause of the approved drug policy envisages that in order to prevent risks of misuse and marketing of drugs by quacks, wherever required, laws would be made and strengthened and that this would also help in regulating commercial advertising and marketing of drugs.  Hence any advertisements and promotion of drugs will be required to provide complete drug information. However approved drug policy of JandK government does not provide any policy framework in relation to curbing the menace of unethical promotion and marketing practices of drugs by pharmaceutical companies that often lead to unethical prescribing by some unscrupulous doctors. In this regard following suggestions put forth by CSF have been dropped by the govt.

a)      All drug promotional practices of pharmaceutical companies and prescribing practices of doctors should be in accordance with Dec.,2010 amendments of the MCI code of Medical Ethics (professional conduct, etiquette and ethics Regulations), 2002 and the prescribers should be made to adhere to these guidelines in letter and spirit.

b)      Authorities of government hospitals, particularly teaching hospitals, should ensure that the activities and conduct of medical and pharmaceutical sales representatives are in conformity with standard ethical norms and do not, in any way, hamper routine patient care.

c)      Drug Policy should ensure rational prescribing practices by all doctors whether in public or private sector, rational dispensing practices by pharmacists and rational use of medicines by the consumers in an integrated and seamless manner.

d)      Promotion-making claims of pharmaceutical suppliers should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste.

e)     Product information of all kinds, should be scientifically valid and evidence-based.

f)      Offering, soliciting or accepting inducements of any kind, monetary or material (except free samples of product in modest quantity) for promotional purpose should not be indulged in.

g)      Prescribing doctors or dispensing pharmacists should not accept support or assistance of any kind conditional upon obligation to promote a medicinal product.

h)      Professional societies, educational organizations may accept partial sponsorship from the pharmaceutical companies for holding scientific meetings and symposia, but this should be clearly stated at the meetings and in proceedings. Care should be taken to ensure that the sponsorship in no way affects the quality of scientific deliberations in the meeting.

LOCAL MANUFACTURE OF PHARMACEUTICALS:                                                

In order to promote self-sufficiency, the state government envisages to encourage, promote and support local manufacturers of pharmaceuticals in the approved drug policy however this is not a good drug procurement practice as per international norms and well-established standards since it tilts the balance in favour of the local manufacturers and discourages reputed pharmaceutical concerns from outside the state from participating in competitive bidding process. Moreover we don’t have sufficient manufacturing concerns operating from within the state. On the pattern of Bengal Chemicals and Pharmaceuticals Limited, Rajasthan Drugs and Pharmaceuticals Limited, our state govt. too needs to establish a govt.-owned pharmaceutical manufacturing unit in accordance with cGMP regulations, however, this suggestion put forth by CSF has not been included in the approved draft by the govt.

HOSPITAL PHARMACY SERVICES:

Good news is that govt. has accepted CSF suggestion and declared in the approved draft that clinical pharmacy services shall be introduced in all major hospitals for the benefit of the patients and in all the hospitals of the state, Drugs and Therapeutic Committees shall be established and made effectively functional, which will be responsible for reviewing drug utilization and promoting rational use of drugs.  Furthermore a state level Drugs and Therapeutic Advisory Committee shall also be constituted to monitor the activities of the drugs and Therapeutic Committees of the hospitals and evidence-based Standard Treatment Protocols shall be developed as the basis for training, prescribing and drug supply. Approved drug policy also envisages that in order to enhance safety of drugs used in hospitals, to monitor and document adverse drug reactions and other adverse events among patients, pharmacovigilance centres will be established in govt. hospitals. Further expertise and human resource in pharmaceutical field will be developed to support the successful implementation of the policy and appropriate in-service training programmes will be designed and implemented to enhance their skills. Another prospective measure that has been adopted in the approved policy is the establishment of Drug Information Centres in the Govt. Medical Colleges to provide appropriate and unbiased drug information to all stakeholders and to publish a state level formulary annually in line with the WHO/national norms.

However CSF suggestion that all hospitals be directed to devise their own hospital drug management policies for efficient management of their resources and drug supplies and the suggestion that in-house Quality Control cells should be established in every major hospital as part of their comprehensive Quality Assurance system have not been included in the approved draft. Services of qualified pharmacy graduates must be made available in all division, district and sub-district level hospitals of the state.

MEASURES TO CURB DRUG ABUSE:

Government of JandK has endorsed CSF suggestions that sale, storage, use of drugs and record keeping specified under Schedule X of the Drugs and Cosmetics Act, 1940 shall be supervised and monitored effectively by the inspectorate staff working under Drug and Food Control Organization, JandK and special checking squads under the leadership of Deputy Controllers will be constituted to undertake periodic inspections in this regard. Approved draft also mentions that Schedule-H drugs shall be strictly dispensed on the prescription of Registered Medical Practitioners. However following suggestions put forth by CSF to curb the menace of drug abuse have not been considered worth inclusion in the final draft by the govt.

a.    License to sell, stock and distribute drugs pertaining to Schedule X should be restricted to dealers with absolutely spotless track record and should not be issued to those indulging in any sort of unlawful activities.

b.    Workforce of the Narcotics Control Bureau should be augmented and its nodal centre established at Srinagar. 

c.    In compliance with NCBI directions, a multi-disciplinary Coordination Committee under the Chairmanship of Chief Secretary or a senior Secretary should be established for regular interaction with various Central and State agencies and to receive support and grant-in-aid assistance from Narcotics Control Bureau of India (NCBI).

d.    The state should set up an Anti Narcotics Task Force under an IG level officer with duties and responsibilities duly demarcated.

e.    Proliferation of drug stores should be discouraged and easy availability of substances of abuse should be reversed.

BLOOD BANKING AND TRANFUSION POLICY:

Regarding this issue of vital significance approved draft of the JandK govt. has accepted CSF suggestion that the best practices will be followed in Blood Banking and Transfusion of Blood. However following important measures as suggested by CSF have not been discretely mentioned in the approved draft.

a.      Procedures of blood banks e.g. blood collection, processing, compatibility testing, storage, component separation, transfusion of blood and blood products and all other related activities shall be practiced as per the rules and regulations under the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 and in accordance with relevant statutory guidelines.

b.      In keeping with the constant needs and constraints, special provisions shall be made to facilitate availability of blood and blood products through a substitute storage system, in peripheral areas where good blood banking system is still in the process of development.

c.       An expert Committee shall devise Standard Operating Procedures and oversee the functioning of all blood banks and peripheral storage facilities to ensure and facilitate the above goals.

FUTURE POLICY AMENDMENTS:

Govt. has decided that the approved policy document shall be reviewed and revised at appropriate intervals based on the need but at-least once every five years but it does not make any commitment that  all stake-holders from hospitals, academia, regulatory bodies, trade, industry and govt. departments shall be involved in the process of review or amendment of the policy. Approved drug policy provides that the state would endeavour to provide financial incentives to promote rational use of drugs apart from regulatory and managerial strategies. However it has not included CSF suggestion that a state level empowered group of experts should be constituted to overlook rational use of medicines, ethical drug prescribing, dispensing and promotion practices in hospitals as well as in the community at large.

Impact of generic drug prescribing policy on pharmaceutical trade of J&K

Promulgation of premier drug policy in the state has led to several apprehensions pertaining to the impact of generic drug prescribing, as envisaged thereunder, on pharmaceutical business/trade in the state. Myths surrounding generic drugs are creating fears that medical representatives may be rendered jobless and pharmaceutical retailers/wholesalers of branded drugs may have to close their outlets. Fact of the matter is that no such thing is going to happen since generic drug prescribing shall for the time being be mandatory only for doctors working in govt. sector and generic drug procurement will apply on supply of drugs to govt. hospitals only. Doctors in private sector can continue to prescribe branded drugs as long as there is some suitable amendment to that effect in the existing drug policy and that is least likely to happen for several years to come given the fact that govt. took more than two years to frame this policy and an amendment in near future seems to be most unlikely even though it is desirable. Therefore those wholesalers or distributors who are not government suppliers can continue with their businesses as usual and even in case of govt. suppliers only the type of drug supply will change not the quantum. Medical representatives too can continue with promotion of branded drugs outside govt. hospitals and branded-generics (for explanation see below) within govt. hospitals. New drug policy won’t make them irrelevant or needless.

Further it is generally believed that generic drugs are sub-standard which is not always true. If there are stringent quality control measures available within state and within government health facilities, good quality generics can be ensured at ease. It all depends on how suppliers are selected for govt. supply, what pre-qualification and post-qualification criteria are fixed for them and what technical specifications are adopted during procurement. Tamil Nadu Medical Sales Corporation adopted generic drug procurement policy that drastically reduced drug costs and considerably increased drug availability and affordability without compromising on their quality. So much so that GOI asked all states to follow TNMSC model for procurement of drugs in govt. sector. No adverse impact was observed on indigenous pharmaceutical trade as a result of this policy adopted by the Tamil Nadu govt. Worldwide, use of generic drugs has led to immense benefits in every respect. The use of generic prescription medicines has saved Canada’s health-care system nearly $26-billion since 2007, according to an analysis of Canadian retail prescription drug sales information released on January 9th, 2012 by the Canadian Generic Pharmaceutical Association (CGPA). The data released today reinforces that the savings provided by generic prescription medicines are essential to the sustainability of both public and private drug benefit plans. Therefore it is very important that several myths surrounding the promotion and use of generic drugs are allayed to pave way for their wider acceptance by doctors, traders as well as patients in the state.

Under new regime, things are supposed to change. An essential list of 348 drugs is prepared first that can tackle not only critical cases but almost all disease conditions. Then only these EDs shall be procured by the govt on their generic or INN names and always kept available within the hospitals. Every effort has to be made to prevent stock-outs. Subsequently all drugs shall have to be prescribed and dispensed only by their generic name or International Non-proprietary Name (INN) in the public sector. Regular Prescription audits shall be commissioned in public hospitals to measure the compliance in this regard. So depending upon how efficiently govt is able to implement these provisions, patients will hardly need to purchase drugs from the open market. And if the system works well, medicos outside the hospitals will start stocking generic drugs and in case of an eventuality (when some drug is not available inside the hospital) generic drugs only will be dispensed by the private chemists.However existing draft of the drug policy does not spell out modalities for those exceptional cases when some drug outside the ED list may have to be prescribed. Regulations might not be too stringent under such situations and doctor may be allowed to prescribe as desirable (including branded). Under standard conditions though rules apply as specified.

Magnitude of Spurious Drug Trade in J&K – Mountain or a Molehill?

Medicines play a crucial role in saving lives, restoring health, and preventing diseases and epidemics, but they need to be safe, efficacious, of good quality, and above all need to be used rationally. When medicines we consume turn out to be spurious, results are counter-productive, they only end up doing harm instead of doing some good to the patient and this goes against the basic ethos of medical practice i.e., “primum non nocere”  meaning first of all do no harm. Every day people suffer and sometimes even die because of spurious and substandard drugs. But how many? We will never know because a patient is always presumed to have died from a disease, rather than the drugs.

Genesis of the Debate:

Issue of spurious drugs in J&K has been hogging the limelight in almost all the local newspapers and tabloids right from the day when on November 12^th, 2011 Dr Naresh Trehan, a renowned cardiothoracic surgeon descended like a messiah and made a sudden prophetic revelation that “Many deaths in J&K are caused by fake, substandard or expired drugs resold in new packages, and it is known to druggists and medicos that many pharma agencies have been doing so with impunity.” Another cardiologist, Dr Surinder Bazaz added fuel to the fire by stating, “I have been practicing in Kashmir since 1997, and have come across drugs which you can find nowhere else in the country. It seems as if this state has turned into a safe bastion for the trade in spurious and substandard drugs, perhaps, the highest number of fake drugs worldwide, is sold here” ¹. Later on, apparently under pressure from some obvious quarters, Dr. Trehan backtracked from his statement and said that he had been misquoted by the press². However his statement had already caused sufficient ripples in the stagnant waters and was enough to trigger panic waves across J&K and spark a continuing debate on the magnitude and nature of this unscrupulous trade in the state. Ensuing debate was also marked by several unsubstantiated claims and sweeping statements by government officials as well as people from pharmaceutical trade, media and civil society. Amidst all the melodrama, moot question remains as to what is the factual position about the extent and nature of spurious drug trade in J&K and why we only talk of spurious drugs and conveniently brush the larger issue of substandard medicines aside? There is dire need to present an unbiased, factual and dispassionate picture of the whole issue that is of paramount importance given its serious ramifications on the health and well-being of common masses.

Definition of a ‘Spurious Drug’

The term ‘Spurious Drug’ has been defined under Section 17-B of the Drugs and Cosmetics Act, 1940, as amended by the Drugs and Cosmetics (Amendment) Act, 1982. A drug is deemed to be spurious if it is manufactured under a name which belongs to another drug, if it is an imitation of another drug or if it has been substituted wholly or partly by another drug or if it wrongly claims to be the product of another manufacturer. While the above-mentioned Act gives proper definitions for adulterated and misbranded drugs, it does not provide any definitions for counterfeit, fake or duplicate drugs, terms that are frequently used in local parlance. A drug is considered to be “Not of standard Quality” or in simple words, “substandard” if it fails to comply with any of the parameters of the overall standards laid down for it either in a recognized Pharmacopoeia or otherwise pre-declared by the manufacturer. According to WHO³, a counterfeit medicine is one which, is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging. Counterfeits are also referred to as SALA (sound-alike-look-alike) drugs.  In all cases, contents of counterfeits are unreliable because their source is unknown or vague and always illegal. Such drugs can cause harm to patients and sometimes even lead to his death.

Global and National Scenario

The United States Food and Drug Administration estimates that counterfeits make up more than 10% of the global medicines market and are present in both industrialized and developing countries. It is estimated that up to 25% of the medicines consumed in poor countries are counterfeit or substandard. These figures place the annual earnings from the sales of counterfeit and substandard medicines at over US$ 32 billion globally⁴. Thus the problem of spurious drugs is reported to be a global phenomenon and India is no exception to this nefarious trade. At national level, 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 as whopping as 35% as per industry claims and the claims made by some independent groups like ASSOCHAM, CII, OECD, EC etc. Within J&K too, on one hand we have hair-raising claims made by common masses and people like Dr Naresh Trehan who believe that vast majority of drugs available in our local markets are spurious and on the other hand we have drug regulatory authorities and the concerned ministry living in a mode of complete denial by saying that spurious drugs do not exist in our markets at all. So these are the two extreme pictures of the problem. Question is whose statement is to be believed by an average consumer and whose claims are based on facts or substantiated by some logical evidence. When we probe and dig a little deeper into the whole matter, we get to know that both sets of claims are themselves spurious and the truth lies somewhere in the middle. So let us dwell into some facts for a better perspective.

It is surprising to know that India’s pharmaceutical companies have themselves suggested that in India’s major cities, one in five medicines sold is a fake. They have claimed that 30 per cent of the Rs 22,000 crore pharma market in India in 2001 was constituted by spurious products. Confederation of Indian Industries (CII) has earlier in its report concluded 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. 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% annually⁵. Similarly, the Organization for Economic Cooperation and Development's figures say that 75% of fake drugs supplied world over have their origins in India. Another report by the European Commission also 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.

On the contrary GOI, health ministry’s estimates are more conservative: it says 5% of drugs in India are counterfeit while only 0.3% are spurious. Based on the samples tested by the State drug testing authorities in India, for the period 1995-2008, the extent of sub-standard drugs varied from 8.19 to 10.64% and of spurious drugs varied between 0.24 % to 0.47%. Details of a 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 Trust⁶, 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 approximately to Rs. 1000 crore (USD 250 million). These figures are considerably lower than Rs. 4000 crore (USD 1000 million) found in CII report.

Scenario within J&K state:

Last year drug control officials of J&K in a review meeting with Divisional Commissioner Kashmir revealed that medicines worth Rs. 600 crore are being consumed annually in J&K of which Rs. 400 crore are consumed in the Kashmir valley alone. A total of 4912 licensed retailers, 4573 wholesalers operate in Kashmir division and a total of 4539 licensed retailers and 1500 wholesalers operate in Jammu division. Thus we have a total of 9451 licensed retailers and 6073 licensed wholesalers operating in the entire state of J&K⁷. Out of a total of 614 drugs tested by the Govt. Drug Testing Laboratory of Srinagar, 25 (4.07%) were declared as sub-standard during 2010 whereas 33 and 37 drugs were declared sub-standard in 2008 and 2009 respectively, none was found to be spurious during this entire period of three years. Officials of the Drug Control Department claim that during 2010, they conducted a total of 8185 inspections during which 645 samples were lifted from the government and private drug sale outlets and only six were found to be ‘not of standard quality’⁸. They further claim that since April, 2011 they have conducted 8549 inspections in Kashmir Valley during which they didn’t find any chemist selling spurious drugs. Further they collected 545 drug samples for testing and didn’t find any spurious drug after analysis by the Govt. Analyst, even though 31 drugs out of these 545 samples were declared to be “not of standard quality”. These claims were made by the Deputy Drugs Controller, Kashmir Division while speaking to the Daily Greater Kashmir⁹, wherein he defined spurious medicine as a drug in which active ingredient is zero percent, and went on record saying that any such drug was not found anywhere in the Valley.

Interestingly while his deputy was vehemently denying the availability of any spurious drugs anywhere in the drug markets of Kashmir, Drug Controller of the J&K state while confirming the use of spurious and sub-standard drugs in the whole of Jammu and Kashmir, particularly in the valley, on a large scale squarely blamed the doctors for promoting the nefarious trade and expressed his helplessness to take any action against them. Drug Controller confirmed to KNS that doctors were playing a key role in the clandestine operations of unrecognized and unlicensed pharmaceutical companies. “However, we don’t have the powers to tighten the noose around such elements,” he said, adding that the doctors involved in it were driven by an uncontrollable lust for money for which they were playing with people’s lives¹⁰. 

Claims and Counterclaims:

Amidst all these claims and counterclaims, it becomes difficult to ascertain actual size of the problem in question. Small companies claim their standards are as high as those of big companies; big companies, meanwhile, accuse the small ones of all kinds of nefarious behaviour – yet still do not hesitate to get the same companies to produce medicines for them if there is a financial benefit in doing so. Regulatory bodies apprehend that the industry agenda seems to be to separate the respectable, safe, large producers from the myriad small- and medium-scale enterprise that comprise more than 85% of the entire Pharmaceutical Sector in India, and thus to establish trust in the big Indian companies and enhance their export potential. They suspect that CII representatives wave the flag of ‘danger to patients’, but actually they seem to be more concerned about danger to their own profits. Since everyone blames everyone else, listening to all sides of the argument does not necessarily get one closer to the truth of the matter. Given the lack of reliable evidence in this area, it is not surprising that unsubstantiated claims and rumours drive out harder sources of information.

Confusion and chaos regarding the extent of spurious drugs in Indian markets is compounded by the fact there are not much credible and comprehensive nationwide or even regional studies available to arrive at any firm conclusion. 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. 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. 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.

Countrywide Survey on Spurious Drugs:

Under pressure from various national and international quarters, government of India launched a pan-India survey a couple of years back. The move was expected to help the health ministry to collect some authentic data on the problem of fake medicines. 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/authentication, 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 report¹¹ 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 [Bihar(5), West Bengal(3) U.P(2) & Gujarat (1)] and the extent of substandard drugs among the branded items was found to be only 0.1 %. In this survey 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 covered under this survey, though it is mentioned that a total of 5665 samples were collected from the entire North Zone including the state of J&K. Further it has been mentioned in the final report that a Jammu-based NGO named Swasthya Sansar under the headship of Sh. Nigham Gupta assisted in collection of samples from the J&K state. Interestingly Sh. Nigham Gupta himself runs a pharmaceutical and medical device distribution agency under the corporate name of J. K. Healthcare Services Group, J&K (Further details at www.jkhealthcareservices.com). That makes the veracity and reliability of sampling procedure adopted at least in J&K under this survey doubtful. Little is known about other NGOs that helped in sampling from other states. As such there is need to conduct an independent  statewide survey on scientific lines to measure the magnitude of spurious drug trade in the state, lifting samples from every nook and corner of the state in a statistically designed unbiased manner.

Etiology of the Problem:

One thing universally accepted by all the stakeholders is that trade in counterfeit/spurious drugs is prevalent internationally and affects both developing and developed countries. Some of the possible factors that contribute towards proliferation of spurious drugs are also universal and include lack of enforcement of existing laws, weak penal action, very remunerative trade, large scale sickness in small scale pharmaceutical industry, availability of improved printing technology that helps in counterfeiting, lack of coordination between various agencies, too many retail & whole sale chemist outlets, inadequate cooperation between stakeholders, lack of control by importing/exporting countries, wide spread corruption and conflict of interests - although appropriate legislation and regulatory systems exists, there is a considerable non-uniformity of enforcement standards followed by state drug control authorities. However in addition to these factors one major factor is the inadequate and weak drug control infra-structure in states as well as centre.

Uncontrolled Proliferation of Drug Stores:

In our state one of the most important factors that contributes largely towards sale of spurious or substandard drugs is the uncontrolled proliferation of drug sale outlets along the length and breadth of the state. Various reasons and solutions for this mushrooming of drug stores in J&K have been discussed at length in an earlier issue of Physicians Academy¹². Here it is noteworthy to mention the statement given by the state’s health minister to Daily Greater Kashmir wherein he candidly admitted that between 2002-2008 no less than 9000 licenses have been issued by the state govt. He even went to the extent of saying that even the vendors got registration during that period. However he tried to absolve himself and his ministry by stating that since he took over as health minister he has put curbs on it and no more than 150 people have got license during his 3 year tenure¹³, whereas if actual reports from the reliable sources on ground are to be believed, during the past three years more than 150 people have been registered as pharmacists in each district, irrespective of their academic qualifications. Never ending process of registration of unqualified people as “pharmacists” that was initiated by the J&K Pharmacy Council more than a decade back is still continuing unabated and every Tom, Dick and Hary, irrespective of his academic qualification is being registered first as a pharmacist merely on the basis of matriculation and five year experience in dispensing drugs and subsequently provided with a drug sale licence on the basis of this registration certificate. This has led to the opening up of floodgates for all and sundry to enter the profession of pharmacy and indulge in the most skilful job of dispensing drugs to patients leading to deterioration of standards and services and malpractices of trade.

Unscrupulous activities of the J&K Pharmacy Council:

Ironically President of the J&K Pharmacy Council who is vested with the official responsibility of cleaning this mess, himself admitted to this anomaly in his statement given to Daily Greater Kashmir, wherein he openly accepted that, “As per the Jammu & Kashmir Pharmacy Act the eligibility criteria for registration as a pharmacist is matriculation with 5 years experience or graduation with 2 years experience. That carried sense when those earning their livelihood had no alternative job avenues. I believe as on date subsequent registration of people as pharmacists should have been stopped but we still follow it under Jammu & Kashmir Pharmacy Act. Education regulation has been implemented in every part of India except Jammu & Kashmir. I have given justification that we have 30-35 colleges in the valley and therefore skilled manpower to take care of our needs”¹³. Now who is going to remind the President of our defunct Pharmacy Council that it is he who has to frame and enforce Education Regulations and take necessary measures to ensure that only qualified people enter the profession by getting registered as Pharmacists. His press statement clearly reveals that either he is himself ignorant of his powers and responsibilities as President of the Council or is deliberately trying to fool the people by giving confusing statements and shifting the onus of responsibility to someone else.

Lack of an effective Drug Policy:

Another important factor that is contributing towards worsening scenario is the absence of a comprehensive, effective and fool-proof drug policy in J&K state. Pros and cons of this issue have also been discussed in an earlier issue of Physicians Academy in detail¹⁴ alongwith the gross deficiencies in the govt draft¹⁵ that has been prepared three years back and is still to see the light of the day. Draft prepared by the govt. in 2009 had completely ignored almost all key issues of public importance like spurious and substandard drugs, drug addiction, irrational prescribing and dispensing of drugs, unethical promotion of drugs by pharmaceutical companies, scientific drug storage, drug recall and disposal of unwanted drugs, clinical pharmacy and drug testing services in hospitals, drug licensing policy, revamping and streamlining the affairs of J&K Pharmacy Council, AYUSH drugs and cosmetics control system, drug price control mechanism, system for reporting and recording quality problems, drug budget requirements etc. It was after Civil Society Forum held a series of marathon meetings with senior functionaries of the health department clubbed with hectic parleys for lobbying and advocacy with senior cabinet ministers of the govt., that some of the deficiencies in the draft were duly addressed and the Commissioner-Secretary Health of the state pledged to incorporate all the suggestions made by the CSF in the final draft. In order to curb the menace of spurious and substandard drugs, author of this article through CSF made several suggestions to the govt. that were mostly based on the remedial measures suggested by several well-known committees of experts like Hathi Committee (1975), National Human Rights Commission (1999), Parliamentary Standing Committee on Petroleum and Chemicals (2001), Mashelkar Commmittee (2003) and National Commission for Macroeconomics and Health (2005).

Remedial Measures to tackle the problem:

Some of the remedial measures suggested to the government were as under:

1. Special courts should be designated to try the cases of spurious drugs.
2. Creation of intelligence cum legal cells in all districts to facilitate busting of spurious drug rackets and their prompt prosecution respectively.
3. Provision of secret funds and incentives to informers giving information about spurious drugs.
4. Training manpower particularly drug inspectorate staff in investigational skills.
5. Monitoring of drugs through supply chain management with proper control on the allied supply industries and transporters.
6. Effective networking system between neighbouring states has to be developed apart from identifying and notifying nodal officers in state and central drug control organizations as well as manufacturers for effective and speedy communication.
7. Creating central registry for formulations under the brand names and their compositions.
8. Necessary changes in law should be made to award severe and deterrent punishments to those dealing with spurious drugs, making the offences cognizable and non-bailable in the light of similar provisions in Narcotic Drugs and Psychotropic Substances Act.
9. Proliferation of drug distribution outlets should not be encouraged. A distance of at least 500 meters should be maintained between two successive shops to avoid agglomeration.
10. Drug sale licences should be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. Necessary amendments have to be made in the relevant Acts to enforce this provision.
11. Preparation of dossiers of suspected dealers and manufactures should be a perpetual exercise. Such dealers will have to be black-listed and their licences cancelled.
12. Manufacturers should be encouraged to have their own anti-counterfeit drug strategies like RFID, QRC etc, better surveillance and efficient complaint handling system.
13. A statewide survey has to be conducted to measure the magnitude of spurious drug trade in the state, lifting samples from every nook and corner of the state in a statistically designed scientific manner.
14. Effective interaction between the stakeholders i.e. industry and regulators, industry and consumers, trade and regulators and medical professional and regulators, should be developed.
15. Creation of advisory bodies at district level with NGOs and Consumer Associations.

Pertinently Health Minister of J&K while talking to Daily Greater Kashmir on October 4^th, 2011 admitted that some reasonable suggestions have come from the civil society and some of these suggestions will be incorporated since we have to draft a policy for the next half a century. However in the same interview, towards the end, he contradicted his own statement and went on to say, “We will sharpen the teeth, let the policy first come subsequently we will incorporate the suggestions of civil society. Let the document come, then we can add the provisions by taking suggestions from the civil society. Amendments can be made afterwards⁸”. So there seems to be a total disconnect in the commitments, policies, priorities and actions of the health ministry. It is high time they realize the gravity of the situation and incorporate the remedial measures suggested above to tackle the menace of spurious and substandard drugs.  

Conclusion:

Many stake-holders are making claims and counterclaims regarding the nature and actual size of the problem of spurious drugs in J&K and are simply passing the buck by shifting the blame on each other. In this debate on spurious drugs, the larger issue of substandard drugs is getting sidelined whereas common people at large who are not aware of the legal intricacies associated with the problem and the jargons involved, perceive substandard drugs too as being spurious. While nothing can be said with confidence about the actual magnitude of the spurious drug trade in J&K since there are no credible, independent, scientific studies available, however based on the causal-effect relationship and the experience gained from their practical use, people at large are not satisfied with the quality of drugs available in the local markets and large scale mass resentment on the issue exists on ground, while the drug regulatory authorities and the concerned ministries continue to be in a continuous mode of denial about the prevalence of spurious drugs in J&K.

Very less percentage of spurious drugs found by the regulatory departments, not only in J&K but across India, upon testing of drug samples lifted by the drug inspectorate cannot be taken as certification or confirmation of their claims that the prevalence of spurious drugs in J&K or across India is negligible for the reason that inspectorate randomly lift drug samples for the purpose of testing from the open shelves of only a few chemists in their jurisdiction areas whereas spurious drugs are stored and sold in a clandestine and surreptitious manner. Surely more vigorous, carefully selected and large scale sampling from every nook and corner of the state by some independent agency would provide a different picture altogether. Those drug samples should receive priority for testing whose purchase records are found to be missing or incomplete at the time of lifting their samples and that look suspicious upon physical examination. Furthermore identity of the manufacturer must be concealed before sending the samples to the laboratory for testing.

Need of the hour is that the issues of spurious and substandard drugs should be viewed in conjunction while assessing the situation or finding a solution, and the two must not be viewed in isolation, for the mere reason that the prevalence of substandard drugs is much more higher than that of spurious drugs and together they pose a similar threat to the health-related quality of life of patients. Secondly govt. must come out of its continuous mode of denial and dispassionately try to address the overall problem of quality control and rational use of medicines in a holistic manner by adopting the remedial measures suggested by the expert committees constituted from time to time in this regard. There are social, economic, administrative, legal and political factors¹⁶ responsible for the grave situation we are witnessing and only govt. or regulatory bodies cannot be blamed for the mess. Hence all sections of the society need to stop pointing fingers at each other and play their important role in alleviating the problem. All stake-holders must shun their confrontationist attitude, stop drawing any mileage and join hands together to curb the menace. Then only some credible progress can be made.

Reference:

1. Daily Greater Kashmir dated Nov., 13^th, 2011.
2. Daily Greater Kashmir dated Nov., 20^th, 2011.
3. http://www.who.int/medicines/services/counterfeit/faqs/count_q-a/en/index.html
4. http://www.who.int/mediacentre/factsheets/2003/fs275/en/
5. http://articles.economictimes.indiatimes.com/2008-02-11/news/28384280_1_fake-drugs-spurious-drugs-counterfeit-drugs
6. http://articles.economictimes.indiatimes.com/2007-11-21/news/27684777_1_spurious-drugs-deputy-drugs-controller-counterfeiting
7. http://www.jkhealth.org/newsite/index.php?option=com_content&view=category&layout=blog&id=96&Itemid=146
8. Daily Greater Kashmir dated April 27^th, 2011.
9. Daily Greater Kashmir dated Nov., 20^th, 2011.
10. Daily Kashmir Observer dated November 24^th, 2011.
11. http://cdsco.nic.in/REPORT_BOOK_13-7-10.pdf
12. Geer MI. Mushrooming of medical stores in J&K state – reasons and solutions. Physicians Academy 2010; 4(7): 74-76.
13. Daily Greater Kashmir, “words that matter” dated October 4^th, 2011
14. Geer MI. Deficiencies in draft drug policy of J&K govt. Physicians Academy 2011;5(2):16-19.
15. Daily Greater Kashmir dated October 4^th, 2011, “Flaws in govt. draft drug policy”.
16. http://kashmiruniversity.academia.edu/GeerIshaq/Papers/935529/Poor_Quality_of_Drugs_-_Mass_resentment_and_factors_responsible