Deficiencies in the Draft Drug Policy of the J&K Government Mohammad Ishaq Geer, Ph.D.

Government of Jammu and Kashmir is currently in the process of framing a Drug Policy for this state. An exercise that was started a couple of years back by the Ministry of Health and Family Welfare is about to reach to its logical conclusion. In this connection a draft of the proposed drug policy was published by the ministry in local newspapers and also uploaded on its official website. Per se the draft looks quite comprehensive but there are several important areas that have been left unattended. Keeping in view the impact of those missing vital policy inputs, it is necessary that these deficiencies are adequately addressed in right earnest before a final shape is given to the proposed policy so that the health and welfare of common masses does not get jeopardized in any manner whatsoever. Need for intelligence and legal cells At present inspectorate staff working under Drug and Food Control Organization (DFCO) is not only levied with the task of conducting inspections, lifting samples of drugs for analysis, recommending cases for grant or renewal of various licenses but also have to investigate rackets of spurious and sub-standard drugs operational in their jurisdiction areas, if any, launch prosecutions in the courts of law against breach of any provisions of the Drugs and Cosmetics Act, 1940 and even plead their cases themselves in absence of any adequate legal assistance in all the districts. Consequently they have to spend most of their time in court hearings. As such need of the hour is to establish intelligence cells in every district of the state to assist the inspectorate in investigating and busting any possible rackets of spurious/sub-standard drug trade flourishing in their jurisdiction areas with provision of lucrative incentives for informers. Similarly establishment of legal cells will allow the inspectorate to devote maximum time to their main duties of enforcing provisions of the Drugs and Cosmetics Act, 1940. Additionally court cases will be better pleaded by legal experts and the conviction rate will rise steeply. Legal cells may include a provision of specially designated courts to try drug cases in order to expedite their disposal. Therefore these provisions need to be included in the proposed Drug Policy of the J&K state. Delegation of powers under Essential Commodities Act In order for the drug inspectorate staff to be able to book the culprits found overcharging patients on sale of medicines, they need to be notified under Essential Commodities Act, without which they cannot enforce the provisions of Drug Prices Control Order, 1995. However it is mandatory to accord them gazetted cadre in order to make them eligible to

be notified as authorized officers under Essential Commodities Act. At present any prosecution in respect of overcharging on drugs has to be instituted by an officer not below the rank of an Assistant Controller or Deputy Controller of DFCO, J&K which delays the matters inordinately since Drug Inspectors are not in a position to take necessary action on spot as warranted under rules against any breach of the Drug Price Control Order. Therefore the upcoming drug policy should ensure that the required status is accorded to the inspectorate staff so that they are notified under EC Act and are suitably empowered to enforce the provisions of DPCO, 1995 failing which some unscrupulous chemists will continue to charge the patients as per their own whims and fancies thus putting an additional burden on the already straining pockets of poor patients. Even though the problem of overcharging has minimized drastically ever since MRP inclusive of all taxes has been introduced on drug labels, it cannot be completely ruled out in some rural and far-flung areas. Implementation of provisions relating to AYUSH drugs Over the past few years, use of drugs belonging to indigenous systems of medicine like Ayurveda, Unani, Siddha and Homeopathy (AYUSH) has gained wide popularity among masses owing to their huge beneficial effects and a large chunk of population is resorting to these forms of treatment for seeking a cure to their ailments. J&K State too has witnessed a massive growth of sale outlets dealing with drugs belonging to one or more of these systems of medicine. However surprisingly there are absolutely no legal or statutory frameworks and mechanisms in place to control, govern, monitor and regulate the sale, storage or distribution of all such drugs including licensing of all such drug sale outlets. Even the necessary powers to enforce these provisions have not been delegated to the inspectorate staff available at present with the DFCO of J&K. At present DFCO issues a few limited licenses only in respect of Unani drugs and there are no provisions for other systems of medicine. Therefore it should be a priority of the state govt. to immediately enforce provisions relating to the manufacture, sale, storage and distribution of such drugs as provided under chapter IV-A of the Drugs and Cosmetics Act of 1940 and thereby bring drug sale, storage and distribution of alternative systems of medicine also under the ambit of Drug and Food Control Organization. Either fresh staff should be appointed or adequate powers should be vested upon the existing staff in this regard until further augmentation is made possible. Supervision, monitoring and control through appropriate regulations and adequate regulatory framework is essential to ensure quality assurance and fair trade practices of these drugs and to prevent mushroom growth of unlicensed stores, sale of any spurious, sub-standard and adulterated drugs belonging to these systems of medicine. Draft Drug Policy is surprisingly silent about this issue and lays no stress on enforcement of these provisions and delegation of necessary powers to the available staff. Therefore this aspect needs to be revisited in the draft drug policy of the J&K govt.

Implementation of provisions relating to Cosmetics On similar lines as above, provisions of Drugs and Cosmetics Act, 1940 dealing with manufacture, sale, storage and distribution of cosmetics also need to be enforced to whatever extent possible in due course of time, since at present there is no regulatory apparatus in place that could govern these aspects of trade in Cosmetics which is a flourishing industry and lack of any regulatory control has led to the flooding of markets with cosmetic products that are not of standard quality. Strengthening of infrastructure for enforcement of NDPS, 1985 Reports of widespread drug addiction and abuse of prohibited medicines have been pouring in from various parts of the state over the last few years in the local media. A tough and stringent piece of legislation namely Narcotic Drugs and Psychotropic Substances (NDPS) Act has been enacted in 1985 to help curb the scourge of drug abuse. Act is a central Act and extends to the state of Jammu and Kashmir too. Most significant feature of the Act is the exemplary punishment provided for most of the offences. The Act is partly enforced by the Excise Department and partly by the Narcotics Control Bureau (NCB) whose workforce is meager and needs expansion. Though this Bureau has a nodal centre at Jammu, there seems to be none in the valley making its activities imperceptible. More people need to be appointed as enforcement officers under the Act for an efficient and foolproof administration of its provisions. In order to make this state eligible to receive support and grant-in-aid assistance from the Narcotics Control Bureau of India, a multi-disciplinary level Coordination Committee under the Chairmanship of Chief Secretary or a senior Secretary has to be established for regular interaction with various Central and State agencies. Additionally our state has to set up an Anti Narcotics Task Force under an IG level officer with duties and responsibilities duly demarcated. In absence of such a committee and task force, this state will not be eligible to receive financial assistance and other support from NCBI. Thus this aspect too needs to be attended to in the Draft Drug Policy of the state. Further adequate safeguards to check the growing menace of drug abuse and to prevent any sale of prescription and scheduled drugs (include Schedule X drugs) without prescriptions, that are already laid down under various provisions of the Drugs and Cosmetics Act and Rules thereunder need to be revisited and made more stringent in the upcoming Drug Policy. Quality Control of drugs and Pharmacy Services in hospitals Though draft drug policy envisages to upgrade and modernize the govt. drug testing laboratories of the state and involve private sector laboratories too, it ignores the importance of establishing in-house quality control cells within hospitals for testing the hospital drug supplies on regular basis by qualified pharmacists. Similarly no thrust is

given to other clinical pharmacy services that could be rendered by qualified and trained pharmacists in the hospitals to further the cause of better pharmaceutical care of the patients. Medical Council of India has put forth certain guidelines with regards minimum requirement of qualified pharmacists in hospitals that have been ignored altogether in the draft policy and need to be implemented. National Human Rights Commission in its report on hospital pharmacy services submitted in January, 1999 has also recommended that, every hospital should organize the pharmaceutical activities in regard to purchase, storage, testing, compounding, dispensing and distribution of drugs under the charge of a competent and experienced persons possessing at least degree in pharmacy. In accordance with these guidelines and the recommendations made vide Hathi Committee Report (1975), it is imperative that the requirements as per MCI guidelines be fulfilled and necessary mechanism devised in the draft drug policy. Further services of at least one pharmacy graduate should be made available at every primary health centre, sub-district and district hospital of the state. Draft drug policy of the state must make it mandatory to engage qualified pharmacy personnel at all primary, secondary and tertiary care hospitals of the state. It is only professionally trained and legally qualified pharmacy personnel who could assist the doctors in counseling patients and disseminating information to them on matters like indications of the drug, its contraindications, adverse effects, precautions, dosage etc and could also play their legitimate and pivotal role in procurement, testing, storage and dispensing of standard quality drugs in every hospital and primary health centre. Enforcement of central Pharmacy Act, 1940 Draft drug policy of the J&K state makes no mention of enforcement of central Pharmacy Act in the state. Just the way central Drugs and Cosmetics Act, 1940 has been enforced in the state, central Pharmacy Act of 1948 too needs to be promulgated in place of J&K Pharmacy Act 2011 (samvat). Draft drug policy of the J&K govt. is silent about this issue too. This step will bring all pharmacy academic institutions of the state under the purview of the Pharmacy Council of India, help our pharmacists in getting registered in the Central Register and practice pharmacy profession anywhere in India. Besides it will also enable our pharmacy institutions seek financial assistance from central councils, organize and participate in their continuing education programmes, seminars etc and achieve national and international level standards in our pharmacy and health education. At present no educational institution imparting degree or diploma course in Pharmacy within the state of J&K falls under the purview and influence of the Pharmacy Council of India due to this lacuna that has been brazenly ignored in the draft policy. Constitution and functioning of the J&K Pharmacy Council Draft drug policy of the J&K state makes no mention of enforcement of Education Regulations or framing Executive Committee in the state. The Jammu and Kashmir

Pharmacy Council has been constituted a few years ago. So far, Council has prepared the first and subsequent registers of those pharmacists who have been carrying on the business or profession of pharmacy in J&K. As a next step, it has to frame an Executive Committee and regulate pharmacy education in the state by way of enforcement of Education Regulations as provided under section 10 of the J&K Pharmacy Act 2011 (samvat). Thereunder it can prescribe the minimum standards of education required for qualification as a pharmacist and can also prescribe the nature and period of study and of practical training to be undertaken before admission to the qualifying examination for a degree or diploma in pharmacy. In absence of Education Regulations there is no binding at present on pharmacy educational institutions to observe and follow any such standards. Once Education Regulations come into force, no person other than a diploma or a degree holder in pharmacy should be designated or registered as a pharmacist and a target date should be fixed beyond which drug trade should be strictly restricted to diploma or degree holders in pharmacy only. In order to cater to the requirement of qualified pharmacy personnel for such endeavor, diploma course in pharmacy may be commenced at govt. polytechnics in Jammu and Srinagar after appointing teaching staff and making other necessary facilities available for the purpose. Furthermore wider participation of the pharmacy professionals drawn from various sections like academia, clinical set up, regulatory affairs, industry as well as sales and marketing in the affairs of the J&K Pharmacy Council shall pave way for its better functioning, improved outcome and greater acceptance of its policies. Its working should not be confined to any one department of the state administration. Since its decisions affect the entire profession, it calls for a broader representation to all concerned as is true with state pharmacy councils of all other states. Other issues not addressed by the draft drug policy: Draft drug policy published by the J&K government is also silent about many other issues like the modalities of training of Human Resource in Pharmaceutical field in absence of Education Regulations and central Pharmacy Act; necessity of the involvement of qualified Pharmacists in Pharmacovigilance and other activities related to quality control and rational use of medicines. Draft does not lay out the modalities for establishment of Drug Information Centres and the qualifications of personnel to be engaged for this purpose since it is very important as to who will provide drug information to the medical and non-medical staff and how. It has not been specified as to where Pharmacovigilance centres will be established because there is need to establish such centres in every large hospital of the state. Therefore it will be in the larger interests of patients of this state if these issues are adequately and appropriately addressed in the proposed drug policy of the state govt.