Drug services to common masses and related issues in the state of Jammu and Kashmir are regulated through Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945, Drug Prices Control Order, 1995 and J&K Pharmacy Act, 2011 (samvat). However there are some other drug legislations that either require promulgation in full or demand enforcement of some of their highly significant provisions in the state of Jammu and Kashmir. A few of such drug regulations are discussed as under.
Drugs and Cosmetics Act
Over the past few years, use of drugs belonging to indigenous systems of medicine like Ayurveda, Unani, Siddha and Homeopathy has gained wide popularity among masses and a large chunk of population is resorting to these forms of treatment for curing their ailments. J&K State too has witnessed 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 provisions and mechanisms in place to control, govern, monitor and regulate the sale, storage or distribution of such drugs or licensing of such drug sale outlets. As a result mushroom growth of unlicensed sale outlets has become a big nuisance along the length and breadth of the state of J&K.
Drugs and Cosmetics Act, 1940 and Rules thereunder were promulgated in the state of J&K in early seventies. Though provisions relating to the manufacture, sale, storage and distribution of such drugs do exist under chapter IV-A and chapter VI-A of the Drugs and Cosmetics Act of 1940, same have not been enforced unlike other provisions relating to the drugs belonging to allopathic system of medicine. Therefore it should be a priority of the state govt. to bring drug sale, storage and distribution of alternative systems of medicine also under the ambit of Drug and Food Control Organization and enforce the provisions relating to their sale and usage. Adequate powers should be vested upon the existing staff in this regard until further augmentation is made possible. Further the provisions of Drugs and Cosmetics Act, 1940 dealing with manufacture, sale, storage and distribution of cosmetics also need to be enforced to the possible extent in due course of time.
Pharmacy Act
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). This will bring all pharmacy academic institutions of the state under the purview of the Pharmacy Council of India, help our pharmacists get 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.
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. Further these regulations shall also lay down the subjects of examination and the standards to be attained therein apart from the equipment and facilities to be provided to students for undergoing such approved courses of study.
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 no person other than a pharmacy degree or diploma holder could apply for a drug sale license. Drug trade should thereafter 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.
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.
After constituting its Executive Committee and enforcing Education Regulations in the state, J&K Pharmacy Council may appoint its own inspectors having prescribed qualifications, as provided under section 26 A of the Pharmacy Act, 1948 in order to inspect the premises where drugs are dispensed, to enquire whether a person who is engaged in selling, dispensing or compounding of drugs is a registered pharmacist, to investigate complaints regarding contravention of the Act and to institute prosecutions against the offenders. This initiative shall help our society get rid of drug delivery and distribution at the hands of unqualified, unregistered and unscrupulous people.
Narcotic Drugs and Psychotropic Substances Act
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. A tough and stringent piece of legislation namely Narcotic Drugs and Psychotropic Substances 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;in some cases rigorous imprisonment upto 30 years in addition to a fine of more than 3 lacs of rupees. Even mere possession of a small quantity of any narcotic drug or psychotropic substance as listed in the Act for an unauthorized personal use or consumption of such drug are cognizable offences under this Act.
The Act is however chiefly enforced by the Narcotics Control Bureau whose workforce is very meager and needs expansion. Though this Bureau has a nodal centre at Jammu, there is none in the valley making its activities imperceptible. More people possessing degrees in Pharmaceutical Sciences need to be appointed as enforcement officers under the Act for an efficient and foolproof administration of its provisions. Sale, storage and use of drugs specified under Schedule X of the Drugs and Cosmetics Act, 1940 has to be regulated with a greater vigil by the inspectorate working under Drug Control Organization. Record-keeping of such drugs should be made indispensable and the same should be checked regularly by the inspectorate. License to sell, stock and distribute drugs pertaining to Schedule X should be restricted to dealers with absolutely spotless track record and those indulging in unlawful trade of such drugs should be severely punished as per law.
Drugs and Magic Remedies Act
With a view to curb the menace of false and misleading advertisements and to prohibit advertisements of certain remedies alleged to possess magical curative properties that are likely to make the ignorant ones resort to self-medication or quackery, the Drugs and Magic Remedies Act was passed in 1954. However the Act extends to the state of J&K only to a limited extent. It needs to be enforced in toto and necessary powers towards its enforcement should be delegated fully to the available manpower that is competent for the same. Ethical criteria for drug promotion and advertising should be established for the state of Jammu & Kashmir along the lines of such ethical criteria developed by the World Health Organization. Drug promotional activities not in accordance with the law may not be permitted in the state. This will help to protect the public from being exploited.
MCI Guidelines
Guidelines put forth by the Medical Council of India with regards requirement of qualified pharmacists in hospitals need to be implemented. They have prescribed a minimum of three qualified pharmacists for every 50 bed-hospital or less, 5 for 51-100 bed hospital, 8 for 100-200, 10 for 200-300 and a minimum of 15 qualified pharmacists for 300-500 bed hospitals. 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 necessary that the requirements as per MCI guidelines be fulfilled and necessary mechanism devised.
Further such positions should be exclusively reserved for trained pharmacy graduates and the services of at least one pharmacy graduate should be made available at every primary health centre, sub-district and district hospital of the state. It is only professionally trained and legally qualified pharmacy personnel who could counsel and disseminate information to patients on matters like indications of the drug, its contra-indications, 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.
State Drug Policy
As a result of increasing complexity of pharmaceutical and healthcare services in the state in the wake of an overwhelming increase in the number of drug sale outlets, an unexpected surge in the morbidity rate, greater number of people resorting to alternative systems of medicine, need for promulgation of a comprehensive drug policy in the state has become inevitable.
Formulation of a new drug policy in the state also assumes immense importance in order to invoke an effective quality control system for drugs, ensure rational prescribing and use of medicines, make safe and effective drugs available in adequate quantities particularly at govt. centers, improve procurement, storage and distribution practices for drugs and other medical supplies, provide quality pharmaceutical and healthcare services at hospitals, stringently enforce all drug-related laws, extend adequate research and training facilities at all academic and healthcare institutions and to initiate indigenous manufacture of life saving drugs within the state. All these vital components of our basic healthcare need to be guided by a strong framework of guidelines envisaged under a proper policy statement.
Given the kind of training and technical know-how of pharmacy graduates, they provide a better choice than simple science graduates in dealing with health related issues concerning the community at large. With their knowledge base on community health education, they are more suited for the posts of community health officers. Hence the minimum qualification for the post of community health officers may be proposed as a bachelor’s degree in pharmacy rather than simple graduation in science as is currently in vogue.
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