1. Adequate Inspectorate Staff in States and Centre:
In India, we have one Drug Inspector overlooking one and sometimes more than one districts at a time. Reportedly there are more than 3.5 lakh sales outlets and only 800-900 drug inspectors for about 600 districts in the country. As per established guidelines, there ought to be at least one Drug Inspector designated for every 100 drug sales establishments or for every 25 manufacturing units. They 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. This has not only been necessitated by the Mashelkar Committe (2003) but also endorsed vide orders of the 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).
In most of the states across India there is paucity of Drug Inspectors and their jurisdiction/workload is not fairly manageable. Recently governments of Karnataka and Gujrat have undertaken drives to recruit good number of Drug Inspectors for their FDAs. In J&K too, a proposal towards creation of 72 posts of Drug Inspectors for their placement at Medical Block level in the state, framed by me on behalf of the J&K Pharmacy Graduates Association was endorsed by the Drugs Controller of the state and subsequently accepted by the ministry of H&FW, J&K govt. The posts already stand advertised and the recruitment process is on at present. There is lack of adequate transportation, accommodation, communication and judicial assistance facilities to the available inspectorate. In J&K, Drugs inspectors are not even conferred Gazetted status making them incompetent to launch proceedings for over-charging of drugs under the provisions of Drug Prices Control Order, 1995.
2. Appropriate Legal Assistance and Intelligence Cells:
The inspectorate have to spend most of their time in courts pleading for various prosecutions launched by them and they are left with no time to conduct any secret probe against possible spurious drug rackets functioning in their jurisdiction areas. There is urgent need to create separate intelligence and legal cells in state as well as central offices with adequate provisions of secret funds and incentives for informers. Further special courts need to be designated to exclusively try the cases of spurious drugs. There should be appropriate incentives for informers who provide vital clues leading to seizure of spurious medicines or busting of such rackets.
3. Adequate Drug Testing Facilities in States and Centre:
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 every state in respect of equipment, technical staff and infrastructure. Modernization and up-gradation of the laboratories should be taken up at war footing basis. Latest testing equipments like HPLC, HPTLC, GC/MS, FTIR, NMR and UV-Spectrophotometry need to be introduced without further delay. Continuing education programmes, training workshops etc will have to be conducted for training the existing technical staff in handling such instruments. 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. All 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 by the state laboratories 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.
4. Creation of awareness among masses:
There is lack of awareness and paucity of informational inputs by common consumers in regard to sub-standard, spurious, adulterated and misbranded drugs, resulting into failure of administration in busting the rackets of spurious drugs. There should be introduction of fundamental medical and health education at the basic high school level. There should be greater recognition of the distinction between qualified and non-qualified pharmacists and the role that can be played by the qualified pharmacists in strategic and scientific administration, preparation, sale, storage and distribution of drugs and pharmaceuticals. Further there should be more resistance on part of druggists, chemists and patients against unethical and irrational prescriptions. There should be larger establishment of private, govt.-approved drug testing laboratories by qualified pharmacists and related NGOs.
5. More Stringent Drug Legislations:
The existing provisions i.e., Section 274, 275 and 276 of IPC/CrPc related to drug offences need to be made non-bailable and cognizable and in consonance with the provisions of the Drugs and Cosmetics Act, 1940. There has been no major amendment in the Drugs and Cosmetics Act, 1940 since 1982. Unlike Labour laws, Act does not allow on-the-spot imposition of fines by inspectorate. As a result, matters get dragged in lengthy judicial procedures yielding very few convictions. Section 27 of the Drugs and Cosmetics Act, 1940 lists out penalties for various contraventions of the Act and Rules thereunder but at the same time authorizes courts to impose a lesser sentence of imprisonment or fine in view of some adequate or special reasons which unfortunately are not amply clear and well-defined in the Act, resulting into reduction of punishments by courts on clumsy and inadequate grounds to only a few hours of imprisonment and a fine up to a few hundred rupees only. At present the offenders usually get bails and the prosecutions normally take about 10-15 years for any judgements. In many cases, the offender may get away with minor punishment whereas in all likelihood, he continues to indulge in spurious drug trade during the period of his trial.
Procedure prescribed under Section 25 of D & C Act, 1940 for retesting of drugs is faulty and provides an ample opportunity for the offenders to escape from the jaws of law. The procedure is so cumbersome, tedious and lengthy that the drug samples in question get expired even before it is retested or any prosecution is launched against the offenders. Narcotic Drugs and Psychotropic Substances Act, 1985 though a strong, stringent and powerful piece of legislation, is not being properly implemented in most of the states due to lack of adequate enforcement staff and non-delegation of relevant powers under the Act to the available manpower.
6. Constitution of Central Drug Authority:
Decision on setting up of National Drug Authority had been taken in 1994 but the same has not been implemented till date, reportedly due to lack of infrastructure. NDA was to be set up for monitoring the prescribing practices and evaluation of their appropriateness for the purpose of guiding the medical professionals and for achieving the aim of rational prescribing. Further it was envisaged that NDA shall be levied with the task of monitoring the standard practices in drug promotion and use, clearly identify those that are acceptable and prohibit those which are unethical and against the consumers’ interests. Failure of the government to establish NDA/CDA has been the biggest hurdle in the way of ethical prescribing and rational use of drugs.
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