SPURIOUS DRUG DEBACLE IN J&K STATE: LESSONS TO BE LEARNT

Startling new revelations are coming to the fore with each passing day in the local press regarding the supply and detection of substandard and spurious medicines particularly in the government run hospitals. A lot has already been written and said about this intriguing problem fraught with disastrous consequences on public health and safety. Mute question remains whether this issue that received enormous media coverage will die down with the passage of time and pass off as just another controversy or some important lessons will be learnt by the powers that be, from this fiasco that enraged and unnerved all sections of our society equally. Even though preliminary enquiry report has been made public by the fact-finding committee constituted by the Ministry of Health and the crime branch has been entrusted with the job of further investigation into the matter, Government of J&K needs to put its act together, ensure adequate checks and balances in its healthcare system and undertake a series of remedial measures in order to curb this menace that has assumed alarming and deleterious proportions. This article proposes a few such steps that need to be taken without any delay in order to prevent the recurrence of such ugly episodes in future.

Impartial enquiry by an empowered committee

Since the preliminary enquiry report has candidly admitted failures on part of Central Purchase Committee and Drug Verification Board members in verifying authenticity of the manufacturer and ensuring quality of the drugs supplied, first and foremost there is dire need to reach out to the roots of this problem. It will be in the fitness of things that a high level, empowered committee of experts should not only expose all the people involved directly or indirectly in the shady spurious drug deal that has shaken the entire healthcare system and damaged its credibility considerably but also make an in-depth investigation into the functioning of Provincial Medical Stores, Central Purchase Committees, Verification Board, Drug Control Department and Drug Testing Laboratories over the past several years. Such an impartial and thorough enquiry assumes importance in the wake of a series of newspaper reports disclosing gross irregularities in procurement, testing and quality control of drugs in the government sector. That can go a long way in revealing all the rot in the prevailing system and pave way for its sustained improvement.

Streamlining supply chain and medicines management

With State Drug Policy already having been approved by the cabinet of ministers as well as the state assembly, Ministry of Health needs to streamline its procurement and quality control mechanism on the pattern of Tamil Nadu and Rajasthan Medical Services Corporation. Drug policy needs to be implemented in letter and spirit as soon as possible and an order must be passed to review and revise the approved drug policy after every three years as against five years mentioned in the policy, so that any genuine grievances arising out of its implementation can be addressed and necessary amendments made to suit various timely needs. Drug selection, quantification, procurement, storage, distribution and dispensing alongwith necessary counseling, monitoring and drug information services to the patients is a highly sophisticated and professional activity that can only be performed by skilled, well-trained and qualified professionals like pharmacy graduates. However in all major and minor hospitals of the state there are either unqualified (matriculates) or under-qualified (Medical Assistants) people managing these affairs leading to frequent failures of the system besides dissatisfaction among patients. Detection of spurious antibiotics is just a manifestation of such systemic failures. Therefore in tune with Drug Policy provisions state govt. must create adequate number of vacancies for pharmacy graduates in all hospitals of the state. This is highly essential for an efficient supply chain management and scientific medicines management within government hospitals.

Legal and administrative reforms

 

On top of everything else, there is need to make necessary amendments in the law so that severe and deterrent punishments are awarded to those dealing with spurious drugs, making all medicine related offences cognizable and non-bailable in accordance with the amendment of Drugs and Cosmetics Act made in the year 2008. Special courts must be designated to try the cases of spurious medicines on fast-track basis and necessary legal assistance should be provided to the drug inspectorate staff in all districts to pursue the offences related to substandard and spurious medicines. Creation of intelligence cum legal cells to facilitate busting of spurious drug rackets and their prompt prosecution must receive top priority. There should be a provision of secret funds and incentives for informers giving information about spurious drugs and the drug inspectorate staff must be suitably trained in collecting intelligence inputs. Their investigational skills required for probing spurious drug rackets must be honed through workshops and other training modules. Further they must be provided all communication, transportation and accommodation facilities required for prompt action in such cases.
 

Drug testing facilities

 

Immediate priority of the state government must be to augment and upgrade the drug testing facilities within the state. In order to ensure timely and accurate testing of all drug samples, existing drug testing laboratories must be upgraded, accredited and provided all necessary funding, manpower and equipments to operate in a more effective manner. Establishing drug testing laboratories in private sector must be encouraged too. A new central, fully equipped and dedicated drug testing laboratory must be established for testing drug supplies at Govt. Medical College, its associated hospitals and all hospitals at district level. Alternatively in-house Quality Control cells may be established in all major hospitals as part of their comprehensive Quality Assurance system. Approved and accredited private drug testing laboratories across India must be empanelled for testing of drug supplies procured by the government. All laboratories must be inspected, audited and validated on regular basis by independent experts from outside the state. Confusion and chaos regarding the extent of spurious drugs in our markets is getting compounded by the fact there are no credible and comprehensive studies available to arrive at any firm conclusion regarding the magnitude of this unscrupulous trade in our state. Therefore there is need to conduct a statewide survey on scientific lines in order to ascertain the magnitude of spurious drug sale in the state. Till such a survey is conducted people will continue to make conjectures regarding the extent of spurious medicines.

 

Quality control of drug supplies in government sector

 

In government sector, every batch of medicines supplied and kept under quarantine should be tested at initial supply stage through empanelled laboratories. Govt. needs to establish warehouses for drug storage in every district on modern lines and ensure timely supply of only standard quality drugs to all govt. hospitals. For this to happen, random samples should be drawn from every warehouse where the batch is supplied. Batch-wise drug sample de-coding should be done through a strictly confidential system and the de-coded samples should be sent for testing randomly to any of the empanelled laboratories located across the Country. Only on receipt of "Quality Passed" certificate from the empanelled laboratories that batch should be released for distribution to government hospitals. Further during the shelf life of drugs, random samples should be periodically drawn from warehouses and quality checked to ensure that drugs are of standard quality right till the date of their expiry. In order to compare and validate the accuracy and correctness of testing quality of the empanelled laboratories, randomly picked control samples should be sent to government laboratories as well as to empanelled laboratories for analysis simultaneously. There should be a provision for pre- as well as post-shipment analysis of all drug consignments received by the govt.

Interaction and collaboration between stake-holders

 

Govt. must involve genuine retailers, wholesalers, working govt. pharmacists as well as their trade associations in tracking spurious drugs and curbing their distribution and sale. We need to develop effective interaction and collaboration between all stakeholders i.e. traders and regulators, traders and consumers, consumers and regulators, medical professionals and regulators, simultaneously. This will facilitate free flow of information regarding substandard and spurious medicines. Trade associations should be impressed to have better surveillance on defaulting members and to take strict action against them. A fool-proof and effective networking system between neighbouring states should be developed and the preparation of dossiers of suspected dealers and manufactures should be a perpetual exercise. Constant surveillance needs to be maintained at all entry points into the state including Lakhanpur and Qazigund toll posts. Regular samples need to be drawn from there for testing of drugs and the purchase bills of all drug consignments entering the state need to be checked on daily basis. On top of them all, creation of better awareness amongst consumers should be accorded top priority.

 

Regulation of drug licensing and registration

 

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. Therefore drug sale licences should not be free for all. They should be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. It is high time that the govt. streamlines its drug licensing and pharmacist registration process. Necessary amendments should be made in the relevant Acts to enforce this provision that includes enforcement of Central Pharmacy Act and implementation of Education Regulations by the J&K Pharmacy Council. Proliferation of drug sale outlets beyond a certain limit must be discouraged. Illegitimate practice of registering matriculates as pharmacists first and then issuing drug sale licences to them must be abandoned forthwith. Chemists on their part must stop issuing experience certificates to such people.

 

Conclusion

 

Many people 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. Some people are demanding scrapping of the approved drug policy which is by no means any solution. In fact a comprehensive drug policy is a remedy to control this and many other drug-related problems. More than anyone else, state government needs to accord top priority to this serious public health concern and ensure speedy implementation of all necessary measures required to root out the menace of spurious and substandard medicines from our hospitals and open markets. Instead of indulging in blame game, all stake-holders including retailers, wholesalers, distributors, doctors, govt. pharmacists, medical representatives, manufacturers, regulators and patients need to do some introspection and join hands to ensure manufacture, supply, procurement, sale, distribution, promotion, prescribing and use of standard quality drugs only. Let us build a safe and secure healthcare system for ourselves and our generation next.

 

(Author teaches at the Department of Pharmaceutical Sciences, University of Kashmir and has been a part of committee that reviewed and revised state drug policy in the year 2011. He can be reached at ishaqgeer@gmail.com)

Measures to curb the menace of spurious medicines

Shocking news about antibiotic supply from a government hospital testing negative is not only adversely affecting the health and well-being of patients who use such medicines but is also wrecking havoc to the confidence of all other patients and has triggered panic waves all across the state. Confusion and chaos regarding the extent of spurious drugs in our markets is getting compounded by the fact there are no credible and comprehensive studies available to arrive at any firm conclusion regarding the magnitude of this unscrupulous trade in our state. However one thing which is universally accepted by all 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.

 

All these multiple causes notwithstanding, there is need to curb this menace in the right earnest. A series of remedial measures need to be taken by the government and all other stake-holders to get rid of this nuisance that is seriously risking the health of patients who consume such medicines. First and foremost there is need to make necessary changes in the law so that severe and deterrent punishments are awarded to those dealing with spurious drugs, making all medicine related offences cognizable and non-bailable in tune with similar provisions in Narcotic Drugs and Psychotropic Substances Act. Special courts should be designated to try the cases of spurious medicines and all legal assistance must be provided to the drug inspectorate staff to pursue the offences related to substandard medicines.

 

A statewide survey should 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. Creation of intelligence cum legal cells to facilitate busting of spurious drug rackets and their prompt prosecution must receive top priority. There should be a provision of secret funds and incentives for informers giving information about spurious drugs and the drug inspectorate staff must be suitably trained in collecting intelligence inputs and their investigational skills required for probing spurious drug rackets must be honed. Further they must be provided all communication, transportation and accommodation facilities required for this purpose.

 

A fool-proof and effective networking system between neighbouring states should be developed and the preparation of dossiers of suspected dealers and manufactures should be a perpetual exercise. We need to develop effective interaction between all stakeholders i.e. industry and regulators, industry and consumers, trade and regulators, medical professionals and regulators, simultaneously. This will facilitate flow of information regarding substandard medicines.

 

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. Therefore drug sale licences should not be free for all. They should be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. Necessary amendments should be made in the relevant Acts to enforce this provision. Proliferation of drug sale outlets beyond a certain limit must be discouraged. A distance of at least 500 meters should be maintained between two successive medical shops.

 

In government sector, every batch of medicines supplied and kept under quarantine should be tested at initial supply stage through empanelled laboratories. Random samples should be drawn from every warehouse where the batch is supplied. Batch-wise drug sample de-coding should be done through a strictly confidential system and the de-coded samples should be sent for quality checking randomly to any of the empanelled laboratories located across the Country. Only on receipt of "Quality Passed" certificate from the empanelled laboratories that batch should be released for distribution to government hospitals. Further during the shelf life of drugs, random samples should be periodically drawn from warehouses and quality checked to ensure that drugs are of standard quality right till the date of their expiry. Randomly picked control samples should be sent to government laboratories as well as to empanelled laboratories for analysis to compare the accuracy and correctness of testing quality of the empanelled laboratories. If any drug batch subsequently fails in quality upon testing, the remaining stock in warehouses should be frozen and the unused hospital stock of the drug of failed batch should be recalled and returned to the supplier. If three batches of any drug fail during tender period either at the time of initial receipt or during the shelf life of the drug the product as well as the company should be blacklisted. Information of failed batches and black listed companies must be put up on the official website of health department. There should be a provision for pre- as well as post-shipment analysis of all drug consignments received by the govt.

 

Drug manufacturers should be encouraged to have their own anti-counterfeit drug strategies like RFID, QRC etc, better surveillance and efficient complaint handling system. Trade associations should be impressed to have better surveillance on defaulting members and to take strict action against them. On top of them all, creation of better awareness amongst consumers should be accorded top priority. In order to ensure timely and accurate testing of all drug samples, existing drug testing laboratories must be upgraded, accredited and provided all necessary funding to operate in a more effective manner. Establishing drug testing laboratories in private sector must be encouraged too. A new central, fully equipped and dedicated drug testing laboratory must be established for testing drug supplies at Govt. Medical College, its associated hospitals and all hospitals at district level. In-house Quality Control cells need to be established in all major hospitals as part of their comprehensive Quality Assurance system.

 

Many people 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. Some people are demanding scrapping of the approved drug policy which is by no means any solution. In fact a comprehensive drug policy is a remedy to control this problem. Instead of indulging in blame game, all stake-holders need to join hands and ensure speedy implementation of all necessary measures required to the root out the menace of spurious medicines from our markets. Government too needs to accord top priority to this serious public health concern.

Drug Policy of J&K state is pro-people

With the announcement of Drug Policy implementation from April this year, made by the Minister for Health, hornet’s nest has been stirred up again and a series of seminars, press conferences and related articles have yet again started surfacing in the local media. People associated with pharmaceutical trade seem to be bracing up for yet another round of agitation against the drug policy. Previous phase of agitation last year witnessed information being propagated in the newspaper columns that was, more often than not, factually incorrect. Before another bout of such misinformation campaign is unleashed, this article attempts to look at the actual facts and dwell into the pros and cons of state drug policy with a view to subside certain misgivings about the same.

First question that needs to be addressed is: what is the need for a state level drug policy? Need for a drug policy arises out of the fact that as per World Health Organization (WHO), one-third of global population comprising 1.3-2.1 billion people does not have access to medicines. At national level, an estimated 50-65% population within India does not have access to medicines as per the World Medicines Situation Report published by WHO. When we look at our own state of J&K, we find that 21% population in our state comprising of 24 lac people are living below the poverty line and it is these people who are deprived of an equitable access to essential and life-saving medicines. Furthermore irrational prescribing and irrational dispensing practices are also rampant in our state. Therefore there is need for a state level drug policy that addresses the issue of accessibility (including availability and affordability) of essential medicines and also devises discrete policy provisions for ensuring quality, safety and efficacy of medicines besides enforcing rational prescribing and dispensing practices and streamlining the procurement and supply chain management of medicines. Since 75%-80% of total expenditure on healthcare in India goes on medicines alone, need to have a drug policy even in absence of a comprehensive health policy in the state is therefore justified.

Next question that needs to be addressed is whether the state drug policy will render lakhs of people associated with pharmaceutical trade jobless. Answer is in negative because generic drug prescribing clause of the drug policy covers only 348 drugs listed in the essential drugs list which comprise only 30% of all the drugs approved in India that are at present available in the market whereas 70% of drugs will still be outside the purview of generic drug dispensing clause of the approved drug policy. Moreover generic drug prescribing applies only to govt. hospitals and not to the private sector pharmacies. It applies only to GMC and its associated hospitals besides hospitals and health centers in various districts. It does not apply to SKIMS and JVC hospitals either. Total budgetary allocations on Drugs and Instruments of all government hospitals of the J&K state does not exceed Rs 25 cores whileas the total worth of drug market in our state has been claimed to be more than 1000 crores per annum. By that measure, entire government drug supply constitutes only 2.5% of the total drug market. Given these facts, it is difficult to conclude how 80% of our pharmaceutical trade is dependent on drug supply in govt. hospitals.

Drug policy that govt. is going to implement is not wholly and solely about prescribing and dispensing generic drugs in govt. hospitals but generic drug prescribing is just one of the many clauses of the drug policy. There are almost a dozen more clauses that concern patients at large that deal with adverse drug reaction monitoring of medicines in govt. hospitals, establishing drug information centres, strengthening drug control department and drug testing laboratories, streamlining drug storage and inventory control mechanisms, promoting human resource, research and development in pharma sector and much more. Nobody seems to have any problems with any of these provisions of the drug policy. All controversies and conflicts of interest surround only one clause of the drug policy i.e., generic drug prescribing in govt. hospitals. Therefore it is grossly inappropriate to outrightly reject the entire drug policy just because one particular clause does not suit the interests of a particular section of the pharma trade.

Even the generic drug prescribing is a policy that has not only been advocated by WHO, National Human Rights Commission in 1999 and Supreme Court of India in 2003, 2012 but also by various committees of experts including Hathi Committee (1975), Standing Parliamentary Committee on Petroleum and Chemicals (2001), Mashelkar Committee (2003) and National Commission on Macroeconomics and Health (2005). Worldwide generic drugs comprise 30% of the total drug sales including branded medicines and constitute a market of 80 billion USD. A total of 75% prescriptions in USA and a total of 83% prescriptions in UK contain generic medicines. Therefore when such affluent and rich nations prefer to use generic drugs there is no reason why poor people of India and other developing nations should be force-fed with costly branded medicines. Some people are apprehensive about the quality of generic drugs but that is only a misconception, far from reality since India supplies quality generics to the global market to the tune of 22% and is known as the “Pharmacy of the developing world”. Highest number of USFDA approved generic drug manufacturers outside USA exist in India. India is a world leader in pharmaceutical sector ranking third in value and thirteenth in volume worldwide. Therefore when India can supply quality generics at affordable prices to the entire world why should 50-65% of its population still lack access to essential medicines. Generic prescribing is the remedy to overcome this dismal scenario.

Some people argue that drug markets within India are poorly regulated leading to manufacture of inferior quality drugs in small shacks that mostly find their way into our shops and hospitals. They fear that introduction of generic drugs will further worsen the situation and deteriorate the quality of drugs. However the degree of market regulation is same for generic as well as branded medicines. Therefore quality will also be the same. If low quality generics can sneak into our hospital supplies so can low quality branded medicines. Therefore with existing drug regulatory and quality assurance mechanisms, situation and degree of quality standards are invariably the same for both generic and branded drugs. Moreover in several other states within India where generic drug prescribing has been implemented, savings to the extent of 30-40% have been recorded in their drug budgets, whose benefits gets eventually transmitted to the patients. Tamil Nadu Medical Services Corporation and Rajasthan Medical Services Corporation have provided role models in ensuring quality as well as low price of generic medicines in govt. hospitals. These models have been duly appreciated and recommended not only by the government of India but by WHO too.

Lastly it is pertinent to mention that Govt. of India has formulated a scheme at the central level that envisages to make generic drugs available free of cost for poor patients in govt. hospitals across India. A sum of Rs 1200 crores have been earmarked during the twelfth five year plan for this scheme and the scheme will take off irrespective of whether a state has its own generic drug policy or not. Therefore generic drug policy will anyhow be implemented in the state through the central scheme. Further there is a provision for the review of the state drug policy every five years. Whatever flaws and loopholes are there in the present policy can be rectified during the subsequent review. However for a successful implementation of the policy it shall be incumbent upon the state government to keep generic drugs available within the hospitals throughout the year without leaving scope for any stockouts at any point of time. Any stockouts within the hospital will lead to substitution of prescribed generics with other generic or branded medicines by private pharmacies. Therefore success or failure of this policy entirely depends on the efficiency of procurement mechanism and inventory control. Govt. has to streamline its procurement mechanism as soon as possible on the pattern of TNMSC so that all apprehensions in this regard are addressed well in time. Further it has been observed that majority of the people associated with pharmaceutical trade are still not aware about the nuances of the drug policy. Therefore there is need to generate awareness among common masses and address genuine grievances of all stake-holders simultaneously. Drug policy implementation should not affect the livelihood of any sizeable section of the society on a large scale. However the slogan should be to fully implement the policy rather than not implementing the policy.

(Article is based on the excerpts from a talk delivered by the author during the seminar on State Drug Policy organized by the Chemists and Druggists Association Kashmir on March 24)

Need for fresh initiatives and novel approaches in the formulation of medicines policies for various Indian states

INTRODUCTION:

WHO defines national medicines policy as a commitment to a goal and a guide for action that expresses and prioritizes the medium- to long-term goals set by the government for the pharmaceutical sector, and identifies the main strategies for attaining them. It provides a framework within which the activities of the pharmaceutical sector can be coordinated. It covers both public and private sectors, and involves all the main actors in the pharmaceutical field¹. Policy discussions about India’s health care system and efforts to change it usually focus on the national level. However National Pharmaceutical Policy in India primarily focuses on issues like import, export, pricing, investments, R&D, industrial licensing and manufacture of drugs and pharmaceuticals whereas various state medicines policies address key issues like safety, efficacy and quality of medicines; promotion of accessibility, rational prescribing, rational dispensing and rational use of medicines besides provision of cost-effective and efficient procurement, storage and supply management systems for medicines. This is so because healthcare is a state subject within India and individual states manage their own healthcare delivery including drug delivery to common masses. Therefore in recent years, there has been increased focus at the state level and more and more states are being provided a freer hand in designing and implementing policies that are specific to their needs and unique circumstances. As such policy makers have to be cognizant of state-level determinants in order to design effective policies to improve drug accessibility and utilization². Therefore, more splitting of India’s medicines policy at the state level would better address their health problems, and would open the way to innovation and local accountability.

India’s population is also undergoing transitions in the demographic, epidemiologic and social aspects of health. Disparities in life expectancy, disease, access to health care and protection from financial risks have increased. These factors are challenging the health system to respond in new ways. The old approach to national health and medicines policies and programmes is increasingly inappropriate. By analyzing inter and intra-state differences in contexts and processes, it is necessary that the content of national medicines policy needs to be made more diverse and accommodating to specific states and districts. States further along the health transition need to develop policies to deal with the alarming issues of spurious medicines, drug addiction, unethical drug promotion practices of pharmaceutical companies and irrational prescribing and dispensing practices. States early in the transition would need to focus on improving the quality and access of essential public health services, and empowering communities to take more ownership. That sets the tone for more splitting of medicines policy approaches in India, a major departure from the past. More explicit and comprehensive state policies and strategies in health and pharmaceutical sectors are needed now more than ever³.

Further in light of the fact that drug and pharmaceutical consumption in Indian states has touched an all time high in the recent years, drug sale outlets have witnessed an overwhelming increase in their number across the length and breadth of every state, morbidity rates have shot up as never before, number of people resorting to alternative systems of medicine has witnessed a boom, policy making officials and bodies of various Indian states need to perceive the immediate need for a state drug policy. This assumes importance because of the fact that most of the Indian states still do not have their own state medicines policies and because they need to take fresh initiatives in tune with ever-changing times and trends in drug and pharmaceutical sector. The need for radically improving the policy framework for this knowledge-based sector cannot be ignored any further.

National Human Rights Commission of India (NHRC) in its recommendations for National Action Plan to operationalize the Right to Health Care has also recommended adoption of a state essential drug policy that ensures full availability of essential drugs in the public health system. It also recommends that the state governments in India should take steps to decentralize the health services by giving control to the respective Panchayati Raj Institutions (PRIs) concerning the government hospitals upto the district level. Enough funds from the plan and non plan amount should be devolved to the PRIs at various levels. The local bodies should be given the responsibility to formulate and implement health projects within the overall framework of the health policy of the state⁴.

Most of the state medicines policies of Indian states contain provisions relating to selection, procurement, storage, distribution and rational use of medicines but there is lack of uniformity in policy components and many state medicines policies lack vital provisions relating to spurious drugs, drug abuse, unethical promotion and prescribing, drug licensing, drug recall, disposal of unwanted drugs, AYUSH (comprising Indian traditional systems of medicine and homeopathy) drugs control, drug safety monitoring etc. Therefore this comparative policy evaluation study was undertaken to make a comparative analysis of policy components of the state medicines policies of six Indian states, make necessary interventions for fresh policy initiatives in the formulation of the maiden drug policy for the state of Jammu and Kashmir (J&K) and suggest new policy initiatives and some novel approaches for other Indian states.

MATERIALS AND METHODS:

This comparative policy evaluation and interventional study was undertaken between September, 2011 to January, 2012. Drafts of state medicines policies of six Indian states viz., Chattishgarh, Delhi, Madhya Pradesh, Orissa, West Bengal and the draft drug policy of Jammu and Kashmir were randomly selected and downloaded from internet for this comparative study based on their availability on the worldwide web. Drafts were analyzed for the presence or absence of various policy components. Subsequently, logical interventions were made through sustained lobbying, persuasive pressure and persistent advocacy to evolve fresh policy initiatives in the formulation and finalization of first drug policy of J&K state and on the basis of experiences gained from the J&K state, suggestions were proposed for new policy initiatives and novel approaches in the formulation of medicines policies for other Indian states that either do not have state medicines policies as yet or their state medicines policies do not have comprehensive provisions to cover all aspects proposed in this paper.

Best elements of all the state policies were pooled and proposed for the formulation of maiden drug policy of Jammu and Kashmir state. While proposing new policy initiatives, due consideration was given to the reports and recommendations of various expert committees like Hathi Committee (1975), National Human Rights Commission (1999), Parliamentary Standing Committee for Petroleum and Chemicals (2001), Mashelkar Committe (2003) and National Commission for Macroeconomics and Health (2005). For inclusion of the proposed provisions in the draft drug policy of J&K state, sustained lobbying was initiated through a Civil Society Forum (CSF) comprising of eminent people from all shades of life including health, judiciary, law, police, mass media, politics and industry. Members of the Forum met Governor, Chief Minister, Health and other cabinet ministers of the Jammu and Kashmir state and impressed upon revising the draft drug policy of J&K framed in 2009 and placed over website of the J&K health department for public review. This political lobbying was supplemented with persistent advocacy with senior bureaucracy of the health ministry and finally a four hour long marathon meeting of the Civil Society Forum members led by this author was held with senior officials of the health ministry of J&K state with a view to incorporate the necessary changes in the draft drug policy of the state.

CSF members through continued motivation and sound explanations pressed for the inclusion of some of the provisions aimed at curbing the menace of spurious medicines, drug abuse, unethical prescribing and promotion of drugs and the provisions relating to drug licensing, cosmetics and AYUSH drugs control, rational blood bank and blood transfusion practices, recall, withdrawal and disposal of unwanted/expired drugs, enforcement of pharmacy education regulations, revamping the activities, composition and functioning of defunct J&K Pharmacy Council, provision of hospital and clinical pharmacy services in govt. hospitals etc. Awareness was raised among common masses as well as among professionals in the field regarding these gross deficiencies in the draft drug policy of J&K state through a series of articles^5-10 in professional journals and local newspapers. After hectic deliberations, some of the suggestions put forth by the CSF members were incorporated in the draft and some were rejected. Subsequently revised draft of the drug policy was accorded approval by the cabinet of ministers of the Jammu and Kashmir state.

RESULTS:

Lack of uniformity in policy components of state medicines policies of five Indian states was conspicuous and most of them were found to lack vital provisions relating to spurious drugs, drug abuse, unethical promotion and prescribing, drug licensing, drug recall, AYUSH (comprising Indian traditional systems of medicine and homeopathy) drugs control, drug safety monitoring etc. After comparative analysis of the draft drug policies of six Indian states and subsequent interventions made in the formulation of maiden drug policy of J&K state, qualitatively, a better policy could be evolved for the state of Jammu and Kashmir through sustained lobbying, persistent advocacy and logical interventions by the Civil Society Forum even though many suggestions of the Forum were dropped by the state government that could have made the draft even more robust and comprehensive.

Based on the success achieved in the interventions made in respect of J&K draft drug policy, new initiatives and novel approaches are suggested in Table-2 for inclusion in the existing state drug policies of those Indian states who already have their own state drug policies but do not cover all these aspects and also for consideration of those Indian states who have not formulated their own state drug policies as yet.

 

DISCUSSION:

In India, it is for the individual states to decide how best they can procure, store and distribute medicines on the basis of their available distribution channels, their topography and available infrastructure; how best they can enforce their drug related laws in their region depending upon the type of drug related crimes most often reported from their area; what type of drugs they should include in their essential drugs list on the basis of adverse drug reaction profile of their region that has been scientifically proved to vary from country to country and from state to state; how best they can enhance the affordability of medicines on the basis of their available manufacturing and other facilities that again vary greatly from state to state, so on and so forth. In nutshell regional variations persist in every state and so do their regional programmes, hence the need for separate regional policies. This paper does not suggest scrapping of a national medicines policy in India, rather it suggests need for a state drug policy in every Indian state in addition to the one at national level, alternatively the need to make the national pharmaceutical policy focus on all areas of regional interests and priorities. Some of the Indian states have framed their own state drug policies but a majority of them lack such robust and comprehensive policy framework to guide their drug delivery services.

In the year 2009, Ministry of Health, government of Jammu and Kashmir state made its draft drug policy public on its official website for the purpose of receiving feedback and suggestions for review from public quarters. Drug Policy had been drafted with broad objectives to promote availability and affordability of medicines; to ensure their safety, quality and efficacy; to promote good prescribing and dispensing practices and rational use of drugs in public and private sectors and to provide a cost-effective, efficient, procurement and supply management system for govt. hospitals. However, draft of the drug policy was found to have specified no policy for curbing the menace of spurious drugs, drug addiction, unethical promotion practices of drugs adopted by pharmaceutical companies, irrational drug prescribing practices of doctors and dispensing practices of pharmacists. Further draft had specified no policy framework for drug licensing, for drug recall and unwanted drug disposal, for drug pricing, clinical pharmacy services and in-house Quality Control testing at govt. run hospitals, cosmetics and AYUSH drugs control etc.

Draft drug policy of 2009 was downloaded alongwith five other drug policies that were in force in five Indian states of  Chattishgarh, Delhi, Madhya Pradesh, Orissa and West Bengal. Comparative study of the six drug policies revealed a number of discrepancies and non-uniformity in their components. Apart from the draft drug policy of J&K state, drug policies of five other Indian states too were found lacking in provisions regarding key public concerns enumerated above. Most of the policies studied laid their focus upon drug procurement, storage and distribution management and had completely sidelined above mentioned components. Among the six drug policies, only the drug policies of Jammu and Kashmir, Orissa and West Bengal had emphasized upon the initiation of pharmacovigilance and drug safety monitoring activities in govt. health facilities. None of the drafts under study had specified any Narcotic Drugs and Substance Abuse Control Policy, Drug Licensing Policy, Drug Prices Control Policy or any Cosmetics Control Policy in spite of the fact that Drugs and Cosmetics Act of 1940 which is currently in vogue in all these states deals with Drugs as well as Cosmetics and consequently quality control of cosmetics goes unchecked in all the states. Drug Policy of only West Bengal had sparingly devised a Spurious Drugs Control Policy and no other state drug policy under study had outlined any policy framework with respect to this burning issue. Similarly drug policy of only West Bengal and Orissa had specified a policy for the control of drugs belonging to Indian Systems of Medicine and Homeopath, collectively known as AYUSH (Ayurvedic, Unani, Siddha and Homeopathy). Among six states under study, only two states had specified a policy framework with respect to drug donations and rational blood banking and transfusion practices whereas only one state each had specified drug prosecution policy and unwanted drugs disposal policy. Three states each had policy components regarding ethical drug promotion, industrial drug manufacturing and research and development in pharmaceuticals sector and only one state regarding promotion of human resource in pharmaceutical sciences.

Only three state drug policies had envisaged to set up drugs and therapeutics committees in govt. hospitals whereas only one state had outlined drug quantification policy. Two of the states had not laid out any policy framework for distribution of drugs to district level facilities whereas three states had not devised any discrete drug tendering policy. One state each had specified no rational drug use and drug information policies in their drafts. Policy regarding preparation of a drug formulary was not specified by two states whereas only two out of the six study states had elaborated upon payment modalities during procurement of drugs. State drug policies of Madhya Pradesh and Orissa were primarily and predominantly drug procurement policies giving elaborate procedures for drug selection, tendering, payments and distribution and laying little emphasis upon other aspects of rational use of quality medicines. However some aspects related to rational use have been covered under Orissa state integrated health policy of 2002. State drug policy of West Bengal was found to be most comprehensive followed by that of Orissa out of all the six drafts studied.

Given these discrepancies, this paper calls for uniformity of policy components in the medicines policies of various Indian states and introduction of new policy initiatives based on novel approaches (outlined in Table-2) to cover the ignored areas of public importance like spurious drugs and drug abuse. This will pave way for improved quality, safety and efficacy of medicines made available to patients at govt. health facilities as well as community pharmacies and to rational drug prescribing and dispensing practices. Standard guidelines can also be made available in this regard by the central government on the pattern of WHO guidelines for national medicine policies.

SUMMARY:

This paper demonstrates that there is need for adoption of fresh policy initiatives and novel approaches in the formulation process of medicines policies for various Indian states and the initiatives need to be incorporated in government drug policies of various states through sustained lobbying, persistent advocacy and logical interventions. Fresh policy initiatives need to be adopted in respect of curbing the menace of spurious medicines, drug abuse, unethical promotion practices of medicines, irrational prescribing and dispensing practices, unwanted drug withdrawal and disposal practices, rational drug licensing policy, rational blood banking and transfusion policy, AYUSH drugs control policy, Cosmetics Control Policy, Drug Prosecution Policy, Pharmacy Education Regulations Policy, Drug Safety Monitoring Policy, Pharmaceutical Care Service Policy etc. There is need for a paradigm shift in the focus from drug procurement to rational use and effective regulations.

Quality pharmaceutical and healthcare services to patients can only be ensured in presence of a strong policy framework that caters to all the needs in respect of drug delivery services and incorporates all components required to enforce and implement existing laws in respect of key issues of public importance. A good number of these novel approaches have already been incorporated in the first state drug policy approved by J&K cabinet of ministers. Similar fresh initiatives need to be adopted in the formulation of medicines policies of various other Indian states that do not have their own state drug policies as yet. In respect of states that already have their own state drug policies, appropriate revisions need to be made to incorporate all these initiatives through sustained advocacy and logical interventions by rational drug use activists and civil society groups.

CONCLUSIONS:

Ø  Various Indian state governments need to move beyond drug selection, quantification, procurement, distribution, storage and use issues while formulating their medicines policies and incorporate fresh policy initiatives as enumerated in Table-2.

Ø  Adequate and appropriate policy framework needs to be outlined in respect of each policy initiative enlisted in Table-2 (Please visit www.drishaqgeer.blogspot.com for more details¹¹).

Ø  While formulating medicines policies, state governments need to address various socio-economic, legal, administrative and political factors that act as barriers in the equitable access and rational use of quality medicines (Please visit www.drishaqgeer.blogspot.com for more details¹²).

Ø  Civil society groups must take like minded people from various sections of the society on board & launch sustained campaign for rational use of quality medicines & make necessary interventions through persistent advocacy & persuasive lobbying in the formulation of robust & comprehensive state medicines policies.

Ø  There is need for more splitting of India’s medicines policy at the state level and providing various states a freer hand in designing and implementing policies that are specific to their needs and unique circumstances. Policy makers have to be cognizant of state-level determinants in order to design effective policies to improve drug accessibility and utilization adopting fresh initiatives and novel approaches outlined here.

REFERENCES:

1.         WHO. How to develop and implement a national drug policy. Second edition. World Health Organization 2001.p4.

2.         Melissa Gatchell, Amardeep Thind, Fred Hagigi. Informing state-level health policy in India: The case of childhood immunizations in Maharashtra and Bihar.  Acta Pædiatrica 2008; 97:124–126.

3.         David H Peters, K Sujatha Rao, Robert Fryatt. Lumping and splitting: the health policy agenda in India. Health Policy and Planning; 18(3): 249–260.

4.         National Human Rights Commission - Recommendations of National Action Plan to Operationalize the Right to Health Care. (http://nhrc.nic.in/disparchive.asp?fno=874 Accessed on March 6^th, 2012.

5.         Geer M. I., Shah M. Y. Guiding Principles for the formulation of a Drug Policy in the state of J&K. Journal of Pharmacovigilance and Drug Safety 2009;6(1):22-26.

6.         Geer, M. I. Mushrooming of medical stores in J&K state – reasons and solutions. Physicians Academy 2010; 4(7); 75-76.

7.         Geer, M. I. Deficiencies in the draft Drug Policy of J&K government. Physicians Academy 2011; 5(2): 16-19.

8.         Geer M.I. Magnitude of spurious drug trade in J&K – Mountain or a molehill? Physicians Academy 2012; 6(1):2-9.

9.         Geer M.I. Approved drug policy of J&K government – A Review. Physicians Academy 2012; 6(2): 27-37.

10.     Geer M.I. Generic Drug Prescribing in J&K - Boone or bane? Physicians Academy 2012; 6(5): 82-87.

11.     http://www.drishaqgeer.blogspot.in/2012/05/fresh-initiatives-and-novel-approaches.html

12.     http://www.drishaqgeer.blogspot.in/2012/05/barriers-in-rational-use-of-quality.html

 Fresh initiatives proposed in the formulation of medicines policies for various Indian states

Ø  Rational Medicine Promotion Policy Ø  Drug Licensing Policy Ø  Rational Blood Banking and Transfusion Policy Ø  Drug Prosecution Policy Ø  Drug Recall Policy Ø  Policy against Spurious Medicines Ø  Control of Narcotic Drugs/Substance Abuse/Drug Addiction Ø  Drug Price Control Policy Ø  Control of AYUSH Systems of Medicines Ø  Disposal of Expired/Unwanted Medicines Ø  Hospital Drug Management Policy Ø  Cosmetics Control Policy Ø  Drug Safety Monitoring Policy Ø  Pharmaceutical Care/Clinical Pharmacy Services Policy Ø  Pharmacy Education Policy Ø  Drug and Pharmacy Regulation Policy Ø  Medical Financing/Insurance Policy Ø  Drug Advertisement Policy Ø  Orphan Drugs Policy Ø  Clinical and Contract Research Policy Ø  Pharmaceutical Research Promotion Policy Ø  Pharmaceutical Manufacturing Policy