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 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. Our basic health and pharmaceutical care needs to be guided by a strong framework of guidelines envisaged under a proper policy statement. At national level, Pharmaceutical Policy of 1994 is currently in force throughout the country including the state of Jammu and Kashmir and measures are afoot to promulgate a new National Pharmaceutical Policy soon countrywide whose draft is currently under review of a 14 member union ministerial panel. However national drug policy inter-alia chiefly addresses provisions relating to import, export, pricing, investments, R&D, industrial licensing and manufacture of drugs and pharmaceuticals that are mainly national concerns rather than regional ones.
Our regional priorities are somewhat different from the national goals. Some of them include effective quality control of drugs; rational prescribing and use of medicines; availability of safe and effective drugs in adequate quantities particularly at govt. health centres; improved procurement, storage and distribution practices for drugs and other medical supplies; quality pharmaceutical and healthcare services at hospitals; stringent enforcement of drug related laws; adequate pharmacy and health education, research and training facilities at all academic and healthcare institutions; indigenous manufacture of life-saving drugs like parenterals etc. These are some of the essential ingredients that constitute a drug policy of any state. However, not many of these vital components of basic healthcare system are guided by way of a robust drug policy in the state of Jammu and Kashmir. Hence keeping in view our regional concerns, the state of Jammu and Kashmir calls for an immediate promulgation of a comprehensive drug policy that could address all key issues related to the availability of safe and effective drugs at affordable prices as well as to their rational prescribing, improved distribution and sale in accordance with various drug laws. Some of the guiding principles that could lay the foundation and provide the basis in formulating a drug policy for the state of Jammu and Kashmir are suggested here. These guidelines are prescribed on the basis of our regional requirements vis-à-vis existing procedures, drug-related laws and demography of the J&K state.
Drug Selection
First step towards framing a drug policy should be to select a limited number of medicines known as Essential Drugs List to be used at the primary health centre level and at different levels of healthcare system throughout the state. Basic objective of this selection shall be to ensure uninterrupted supply of drugs of right quality, in a right quantity at a right price from the right source. This is the cornerstone of any drug policy. Preparation of this list as per the local requirements and with particular focus to the diseases endemic to this region shall reduce drug procurement costs, ensure better availability of life-saving drugs throughout the year in every nook and corner of the state. Thus our capital expenditure can be directed in the most profitable direction resulting in its more economic use.
Procurement, Storage and Distribution
In order to maintain supply of medicines in time, reduce investments in inventories, make effective use of capital, procure drugs at a minimum price without compromising on their quality and to avoid stock out, shortages, duplication and wastage, modern techniques of drug storage and inventory control should be introduced. Drugs existing in the list prepared as above should be procured by two fully-computerized centralized procurement, storage and distribution stores, one at Srinagar and the other at Jammu. Scientific and modern methodology for drug storage and inventory control needs to be adopted so that the central unit is aware at any time of the different drugs available at the different hospitals and health care facilities. Checks and counter-checks, such as computerized inventory systems, modern accounting procedures, and surprise checks may be initiated to ensure that losses due to illegitimate activity is kept down to the bare minimum. Training of pharmacists through continuing education programmes in store-management and improvements in monitoring systems should also form an integral part of the system.
Drug Laws Enforcement Administration
Drug control enforcement staff should be augmented and strengthened in tune with the recommendations of several committees set up for the purpose. There should be at least one drug inspector available at every Block level in the state. In this direction, a detailed proposal framed by this author on behalf of the J&K Pharmacy Graduates Association towards creation of 90 posts of Drug Inspectors and their subsequent placement at medical Block level in the state, after having been duly endorsed by the Drugs Controller of the J&K state has been finally accepted by the Ministry of Health and Family Welfare, J&K Government that has recently issued directions vide Government Order No. 604-HME of 2007 dated 10.09.2007 towards creation of 72 posts of Drug Inspectors (though not at Block level) in the state. Presently drugs falling under alternative systems of medicine including Ayurveda, Unani, Siddha and Homeopathy are not regulated by any legal framework in our state so far as their sale, storage or distribution is concerned. Though provisions relating to these aspects have been very well outlined in the Drugs and Cosmetics Act, 1940 and Rules thereunder, these provisions have not been enforced unlike other provisions relating to the drugs belonging to the allopathic system of medicine. Therefore it should be a priority for the state govt. to bring drug sale, storage and distribution of alternative systems of medicine also under the ambit of Drug and Food Control Administration and 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 the manufacture, sale, storage and distribution of cosmetics may also be enforced to the possible extent in due course of time. Moreover adequate transportation, accommodation, communication and judicial assistance facilities to the available inspectorate staff are essential for proper enforcement and efficient monitoring of drug regulatory legislations within the state. It is therefore high time to revive, revamp and reconstruct our drug control administration on the pattern of organizations like FDA, Maharashtra.
Quality Control of Drugs
There is a need for an urgent augmentation of the drug testing facilities in the state in respect of equipment, technical staff and infrastructure. Modernization and up-gradation of the two existing drug-testing laboratories at Jammu and Srinagar should be taken up at war footing basis. Third generation testing equipments like HPLC, HPTLC, GC, FTIR, UV/IR-Spectrophotometry, NMR and Mass Spectroscopy need to be introduced in a phased manner. Moreover an ever-increasing need for more extensive testing and analysis of drugs and pharmaceuticals demand more number of posts of Govt. Analysts and other skilled technical personnel for such analysis. Annual testing load and average testing time of each laboratory should be streamlined and fixed in line with the available facilities. Both testing laboratories should be sophisticated to the extent of making them able to test all kinds of drugs including parenterals. At present, most of the parenteral products (injectables) are sent to CIPL, Ghaziabad as the necessary facilities are not available here thus causing inordinate delay in initiating legal proceedings against the defaulters. Quality control cells will have to be constituted in every major hospital as part of in-house Quality Assurance system.
Drug Prices Control Mechanism
Drug prices are determined by the National Pharmaceutical Pricing Authority of India at the central level and enforced by various states including that of J&K in accordance with the provisions of the Drug Prices Control Order of 1995. In order to enable the drug control administration staff to enforce these provisions, they have to be notified under para 21 of DPCO, 1995 as enforcement officers as envisaged under Essential Commodities Act, 1955. In the state of Jammu and Kashmir inspectorate staff is not empowered to take any legal action against any individual or dealer found charging in excess to the amount prescribed because they have not been notified under DPCO, 1995 or the Essential Commodities Act, 1955. Under these circumstances all offences relating to excessive charging of taxes etc have to be prosecuted by the higher officials of the dept. and the field staff finds itself helpless in such cases. As such, inspectorate needs to be properly notified and necessary status needs to be accorded to them in this regard so that prompt action could be initiated in cases of exorbitant/exploitative charging of prices on drugs.
Pharmacy Education and Training
Executive Committee of The Jammu and Kashmir Pharmacy Council has to frame 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. 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 or be eligible for grant of a drug sale license. In order to cater to the requirement of qualified pharmacy personnel for such endeavour, diploma course in pharmacy may be commenced at govt. polytechnics in Jammu and Srinagar after appointing adequate teaching staff and making other necessary facilities available for the purpose. 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, enable them to participate in the continuing education programmes, seminars etc of the central Council and help our pharmacists get registered in the Central Register.
Rational Prescribing and Use of Drugs
A State Pharmaceutical Rational Use Society may be set up to monitor the drug prescribing practices of physicians and evaluate their appropriateness with an intention to guide the medical professionals for achieving the aim of rational prescribing. Such a Society may also be levied with the task of monitoring the standard practices in drug promotion and use, clearly identifying those that are acceptable and prohibiting those which are unethical or against the consumers’ interests. Such a measure is indispensable for accomplishing the goal of ethical prescribing and rational use of drugs since at present there are no legalities in place to regulate these vital issues of healthcare resulting into irregularities like polypharmacy i.e., unnecessarily heavy prescriptions and other gratifying drug promotional practices that are widely debated every now and then in the media.
Hospital Pharmacy Services
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 of qualified pharmacists commensurate to the total bed strength of the hospital be fulfilled and necessary mechanism devised.
Way back in 2004, Director Health Services Kashmir in his proposal (though not a detailed one) sent to the Commissioner-Secretary, Health & Medical Education, J&K state vide No. Est-I/NG/Pharmacy Grad/11/14 dated 10.04.2004 had strongly endorsed the need for engaging services of qualified pharmacists holding bachelor’s degree in Pharmaceutical Sciences in Associated Hospitals and health services at the provincial, district and block level health centres in the state. He had worked out the total requirement of these posts at 105 with a net financial implication of Rs. 9.88 lacs. However this initiative of Director Health Services could not take off due to lack of either will or resources and as a result there has been no headway in this direction so far. Nevertheless there is dire need of upgrading our pharmacy services at provincial, district and block levels by availing the services of qualified professional pharmacists. Further, in order to economize our drug budget, minimize our expenditure on some of the hospital pharmaceutical supplies and make quality drugs available at affordable prices at our primary, secondary as well as tertiary care hospitals, it will be apt to frame a detailed proposal in consultation with Industries department for the establishment of a govt.-owned pharmaceutical manufacturing unit in the state.
Monitoring and Evaluation of the Policy
Ministry of Health and Family Welfare may frame a committee that would monitor and evaluate the drug policy once it is formulated and would also supervise its implementation and conduct regular, periodic revisions whenever and wherever required. This committee may also observe its performance in relation to projected activities and point out specifications demanding amendment and improvement from time to time. The afore-mentioned objectives serve as a collective statement of goals to be achieved in our healthcare system. Transforming these goals into realities will require dedicated efforts on part of the govt., healthcare professionals as well as common consumers. On the contrary, continued absence of a comprehensive drug policy will freeze all opportunities of progress and development in our drug control and delivery mechanism.
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