The multiplicity of drugs, the increased number and kinds of medications prescribed per patient, the increased number of both in-patients and out-patients who are being treated and the ever changing concepts of medical care make it mandatory that a system of safe medication practices be developed and maintained to ensure that the patients receive the best possible treatment, care and protection. Drug inspectors are the only personnel legally empowered to enforce various provisions of the Drugs and Cosmetics Act. We should have them in adequate numbers so that they share a manageable jurisdiction and workload.
To reinforce and ensure effective control over the quality and efficacy of drugs as well their sale in accordance with set norms, drug control enforcement staff needs to be augmented and strengthened in tune with the orders of Supreme Court of India and the recommendations of several committees like Hathi Committee report (1975), National Human Rights Commission Report (1999) and the report of Parliamentary Standing Committee on Petroleum and Chemicals (2001). The Mashelkar Committee on Pharmaceutical Research and Development (2002) has also recommended the establishment of a first class Drug Regulatory infrastructure in every state. There has to be at least one drug inspector designated for every 100 sales outlets or 25 manufacturing establishments. Accordingly there should be one drug inspector available at every block level in the state. In light of the fact that there are only 103 medical blocks in the entire state, net financial implication of this augmentation is estimated to be not more than rupees 1.25 crore per annum. This much financial burden on the state exchequer should be quite bearable in the face of its potential benefits in terms of an effective drug control mechanism in the state. In this direction, there has been a breakthrough in that 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 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. However inordinate delay is being caused in the prompt advertisement and subsequent recruitment against these posts that is posing hurdles in effective enforcement of the provisions of various drug legislations like Drugs and Cosmetics Act etc in the state.
Presently drugs falling under alternative systems of medicine including Ayurveda, Unani, Siddha and Homeopathy are not regulated by any legal framework so far as their sale, storage or distribution is concerned. Though provisions relating to these aspects have been 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. This shall in turn further strengthen the need for expansion of manpower presently available with the Drug and Food Control Organization, J&K. Further adequate transportation, accommodation, communication and judicial assistance facilities to the available inspectorate staff are extremely vital for proper enforcement and efficient monitoring of drug regulatory legislations within the state and hence need immediate attention to the maximum possible extent. It is therefore time to revive, revamp and reconstruct our drug control administration on the pattern of states like FDA, Maharashtra so as to make drugs of best quality, safety and efficacy available to the masses at reasonable rates along with suitable counseling services by qualified pharmacists at drug distribution outlets.
As the number of brands available in the market keep soaring, the issue of quality will assume permanent importance. Across the globe, countries are adopting rigorous drugs quality control systems and enforcement mechanisms to avoid sub-standard/spurious drugs in their respective markets. Adequate and up-to-date drug testing facilities are essential for an exact estimation of frequency and prevalence of spurious drugs in the market. As such, there is a need for an urgent augmentation of the drug testing facilities in our 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/MS, FTIR, NMR and UV-Spectrophotometry need to be introduced in a phased manner. Continuing education programmes, training workshops etc will have to be conducted for training the existing technical staff in handling such instruments. Further, govt. should also consider setting up of an additional, state-of-the-art, modern and fully equipped drug testing laboratory under the auspices of Central Drug Standards Control Organization (CDSCO), Ghaziabad or in association with Union Ministry of Health and Family Welfare. 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 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 inspectorate staff of this state have to spend most of their time in courts pleading for various prosecutions launched by them and are left with very little time to conduct probe against spurious drug rackets operating in their jurisdiction areas. There is urgent need to create separate intelligence and legal cells in the state as well as central offices with adequate provisions of secret funds and incentives for informers. In addition special courts need to be designated to exclusively try the cases of spurious drugs. Severe and deterrent punishments as afforded under law should be imposed on persons dealing with spurious drugs. Several countries across the globe have introduced death penalty for the persons involved in spurious drug trade. Such kind of exemplary penalties need to be awarded to those found guilty of perpetrating such a heinous crime against humanity. Moreover there has not been a comprehensive review of the Drugs & Cosmetics Act 1940 since its enactment, although Rules have been amended from time to time to keep them up to date and there is also an ever growing concern regarding the problem of spurious drugs. It is important to see all the issues in an integrated manner.
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