Drug Policy Falls Short

Dr. Ishaq points shortcomings in the 2009 draft

(Dr. Geer Mohammad Ishaq teaches at the Department of Pharmaceutical Sciences, University of Kashmir, and has written this article on behalf of Civil Society Forum that has been pressing for effective implementation of a drug policy in the state)


Flaws in J&K Draft Drug Policy

After years of advocacy and lobbying by various civil society and professional groups, Ministry of Health, Government of J&K framed a draft drug policy in the year 2009, published it in local newspapers and placed it on the ministry website for comments and review. Even though a couple of years have passed since then, promulgation and effective implementation still eludes a robust and comprehensive drug policy in this state. Per se the draft looks quite elaborate but there are several areas of crucial importance that have been left unattended. Almost all major issues of serious public concern that inter alia include sale of spurious and sub-standard drugs, menace of drug addiction, unethical drug promotion practices of pharmaceutical companies, unethical drug prescribing practices of some unscrupulous doctors, sale of drugs by licensed but unqualified pharmacists have been completely ignored in the draft. It seems that all stake-holders, experts and professionals in the field have not been consulted before framing the draft policy. Therefore in the light of the huge impact of these missing vital policy inputs, it becomes mandatory to revisit the draft, consult all relevant sections of the society and address these flaws in the draft in right earnest before a final shape is given to the proposed policy so that the health and welfare of common masses do not get jeopardized in any manner whatsoever.

First and foremost, proposed draft drug policy of the J&K government does not lay out any standards of quality that the drugs purchased by the health department have to comply with. Standards of quality and purity of drugs have to be in accordance with Indian Pharmacopoeia, 2010 and National Formulary, 2010. This is a technical hitch in the draft with far-fetched legal ramifications. Draft policy just mentions that the drugs will be centrally procured by J&K Medical Sales Corporation but does not put forth any broad policy framework before the proposed corporation as required for tendering, supplier selection, pre-qualification, post-qualification, quality assurance etc. This can pave way for gratification practices and bending of rules to one’s illegitimate advantages. No Drug Recall Policy has been specified in the draft that can cause severe financial losses to the state besides leading to over-stocking of useless medicines. Recalls are actions taken by a firm to remove a product from the market on a firm’s own initiative, by FDA request, or by an FDA order under statutory authority.

Draft policy of the state govt. does not put forth any policy parameters required to curb the menace of spurious drugs or on the need for introducing WHO-IMPACT approved anti-counterfeiting technologies in the drug procurement system. There is no mention of constituting legal and intelligence cells for speedy culmination of prosecutions and busting of fake drug rackets respectively. There is also a dire need to conduct a comprehensive statewide survey on spurious drug trade wherein large number of samples need to be lifted from every nook and corner of the state to arrive at a firm conclusion about the magnitude of this problem prevalent in the state. There is no roadmap for countering the menace of drug abuse/addiction. Even though this draft is not meant to cover narcotic drugs that fall under the purview of Excise Department, yet abuse of prescription drugs and psychotropic substances has to be tackled in this draft. This aspect too has been blatantly neglected in the draft. Drug licenses for selling Schedule X drugs have to be limited only to those retailers with spotless track- record in dealing with such drugs. There is no clarity in the draft as to how drug price control mechanism will function when the available field staff, the drug inspectors, are not authorized to take action in cases of overcharging on drugs; since as required under law, they are not notified under Essential Commodities Act because they fall under non-gazetted cadre at present.

There is no policy outlined in the govt. draft for licensing, monitoring, regulation and control of drugs belonging to Indian System of Medicines in absence of which anybody can carry on with illegal business of such drugs with impunity. Therefore provisions relating to AYUSH drugs as provided under Chapter-IV A of the Drugs and Cosmetics Act, 1940 need to be enforced through the drug policy and adequate powers need to be delegated to the inspectorate staff. Need for having Drug Inspectors at block level in the state instead of district level, as is presently in vogue, for greater and effective control and vigil has not been emphasized in the draft. Draft talks about Quality Control system but fails to outline the importance of a comprehensive Quality Assurance System that includes perpetual surveillance besides testing and includes not only technical activities but managerial aspects too.

Govt. draft mentions about developing human resource in pharmaceutical science but how is that possible in absence of central Pharmacy Act and in absence of any Education Regulations within J&K Pharmacy Act. In absence of pharmacy education regulations anybody can run a pharmacy college without following any rules and anybody can enter this profession without earning a legal qualification. Draft drug policy makes no mention of the J&K State Pharmacy Council whose constitution and functioning has been kept restricted and not all-inclusive. There is no representation from academia, hospitals or drug industry in the Council. It hasn’t framed its executive committee even after more than a decade of its constitution. Council is responsible for mushroom growth of drug stores along the length and breadth of the state that are sans qualified pharmacists by offering a never ending process of registration under J&K Pharmacy Act. No minimum qualification required for the issuance of drug licences in the state has been specified in the draft policy since at present any Tom, Dick and Hary can get a licence by first registering himself as a pharmacist with the J&K Pharmacy Council merely on experience basis. Draft lays down no roadmap for providing life-saving medicines free of cost to poor patients living below the poverty line by strengthening and implementing Rashtriya Swastha Bhima Yogna and by constituting State/District Illness Assistance Fund, District Drug Banks and Revolving Funds for BPL families. Annual testing load and average testing time of the drug testing laboratories shall have to be fixed for greater accountability. Draft drug policy while emphasizing upon involving private sector laboratories in ensuring quality of drugs in the state, does not spell out the importance of getting such private testing laboratories approved by CDSCO, in absence of which their test reports will not be held valid by the court of law.

There is no policy spelled out in the govt. draft for disposal of expired and unwanted drugs which has of late proved to be a grave environmental concern worldwide owing to their potential to pollute underground water reserves and return back to our systems. Draft policy does not lay down any policy for establishing in-house Quality Control cells within hospitals and providing clinical pharmacy and pharmaceutical care services to patients there with a view to maximize clinical outcomes of drugs. Draft drug policy does not specify minimum drug budget requirements of the state nor does it fix a minimum per capita per annum expenditure on drugs out of the total hospital budgets. Draft drug policy is silent about the provisions of Drugs and Cosmetics Act dealing with regulatory control over sale, storage and distribution of Cosmetics since lack of any regulatory control has led to the flooding of markets with cosmetic products that are either spurious or are not of standard quality.

Draft policy does not emphasize upon the need to have a robust system for reporting and recording quality problems at various sites throughout the year. No pre-qualification criteria to be met by the drug suppliers has been outlined in the draft policy that leaves room for wrongful selection of suppliers during tendering process. Other criteria for vendor selection like their ORG rankings, GMP standards, market standing, annual turnover etc have also not been specified in the draft. It does not specify whether drugs will be procured by the J&K Medical Sales Corporation directly from the manufacturers for cost-effectiveness or otherwise. Importance of pre and post-shipment analysis/testing of drug consignments has not been emphasized upon in the draft. Apart from drug advertising, rational drug marketing practices too need to be adopted in the draft policy. All drug promotional practices of pharmaceutical companies have to be in accordance with 2010 amendments of the MCI code of Medical Ethics (professional conduct, etiquette and ethics) Regulations, 2002 and the prescribers have to adhere to these guidelines in letter and spirit. Drug Policy must ensure rational prescribing practices by doctors, rational dispensing practices by pharmacists and rational use of medicines by the consumers in an integrated and seamless manner. Civil Society Forum Kashmir, that has been knocking at every door to get these flaws in the draft drug policy rectified, is of the firm belief that the draft needs to be reframed after a thorough revision and a robust and comprehensive drug policy needs to be implemented in the state as soon as possible.