1. Draft drug policy does not lay out the standards of quality that the drugs procured by proposed J&K Medical Sales Corporation have to comply with. Standards of quality and purity of drugs have to be in accordance with Indian Pharmacopoeia, 2010 and National Formulary, 2010.
2. Draft policy just mentions that the drugs will be centrally procured by J&K Medical Sales Corporation and does not specify the policy and procedures of the proposed sales corporation required for tendering, supplier selection, pre-qualification, post-qualification, quality assurance, ordering, payments etc. Thus it is a half-baked policy.
3. No Drug Recall Policy has been specified in the draft. Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.
4. Draft policy of the 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 launch of prosecutions and busting of fake drug rackets respectively.
5. There is no roadmap for countering the menace of drug abuse/addiction. This aspect has been blatantly neglected in the draft. Drug licences for selling Schedule X drugs have to be limited only to those retailers with spotless track- record in dealing with such drugs.
6. 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 of falling under non-gazetted cadre.
7. There is no policy outlined for licensing, monitoring, regulation and control of drugs belonging to AYUSH systems of medicines in absence of which anybody can carry on with illegal business of such drugs with impunity. Provisions relating to such drugs as provided under Chapter-IV A of the Drugs and Cosmetics Act, 1940 need to be enforced and adequate powers need to be delegated to the inspectorate staff.
8. Need for having Drug Inspectors at block level in the state instead of present district level for greater and effective control and vigil has not been emphasized in the draft.
9. 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.
10. 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. In absence of pharmacy education regulations anybody can run a pharmacy college without following rules and anybody can enter this profession without earning a legal qualification.
11. 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 of 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.
12. 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.
13. Draft lays down no roadmap for providing 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 and other central schemes.
14. Annual testing load and average testing time of the drug testing laboratories shall have to be fixed for greater accountability.
15. Draft drug policy while emphasizing upon involving private sector laboratories in ensuring quality of drugs in the state, does not realize the importance of getting such private testing laboratories approved by CDSCO, in absence of which their test reports will not be held valid in the court of law.
16. There is no policy 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 bodies.
17. 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 within hospitals with a view to maximize clinical outcomes.
18. Draft drug policy does not specify drug budget requirements of the state nor does it fix a minimum per capita per annum expenditure on drugs out of our hospital budgets.
19. 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.
20. Draft drug policy is also silent about the specific choice of formulations, packaging and labeling requirements to be fulfilled by the suppliers of drugs. While procuring drugs preference must be given to tablets over capsules, reconstitutable powders over injectable solutions and to strip and blister packaging over loose/bulk packaging. Special labeling requests like “only meant for sale by J&K Medical Sales Corporation” have to be accepted by the suppliers.
21. 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.
22. 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.
23. Draft drug policy does not specify whether drugs will be procured by the J&K Medical Sales Corporation directly from the manufacturers for cost-effectiveness or otherwise.
24. Importance of pre and post-shipment analysis/testing of drug consignments has not been emphasized upon in the draft policy.
25. Draft drug policy of the J&K government is not in consonance with the recommendations of Hathi Committee (1975), National Human Rights Commission (1999), Parliamentary Standing Committee on Petroleum and Chemicals (2001) and Mashelkar Committee (2002).
