Must Read Article: PHARMA, JOURNEY TO……. JAIL

As per WHO, National Governments are responsible for establishing strong National Drug Regulatory Authorities (DRAs) with clear mission, solid legal basis, realistic objectives, appropriate organizational structure, adequate number of qualified staff, sustainable financing, access to technical literature, equipment and information, capacity to exert effective market control, DRAs’ must be accountable to both, the Government and the public and their decision making processes should be transparent. Monitoring and evaluation mechanisms should be built into regulatory system to access attainment of established objectives.

As on today the Indian Drug Laws are under revolutionary changes, for the last over about 10 years the licensing to manufacture for certain category of Drugs and Pharmaceuticals have been assigned to Central Drugs Standard Control Organization (CDSCO) in DCGI office, the provisions of ‘New Drugs’, Banning of irrational FDC etc. have been introduced / widened. The Government of India is also in process to form National Drug Authority, desiring (?) it to be at par with US FDA and before that squeezing of powers of State FDA on various counts is in pipeline.

The trend of transfer of power from States/UTs to CDSCO, as for as related to licensing to manufacture drugs is clearly seen from the year 1996 when power to license to manufacture Large Volume Parentrals were shifted from States to CDSCO. It continued with widening of criteria of ‘new drug’, though public does not know claims approved. This power game is on enlargement to formation of proposed National Drug Authority (NDA) under the shadow of uniform implementation of the ‘Act’ and ‘Rules’. Though the Licensing/Approving powers in respect of some of the categories are vested with the Central Drug Regulatory is not uniformly implemented and it is also a party to violation of present Drug Laws.

The Indian regulatory system is nowhere close to the sophisticated regulatory systems of developed nations, and because the enforcement of legislation is much poor than internationally accepted norms, the entry barrier for developed nations into the Indian market is practically non-existent.

The U S Supreme Court upholds the 1962 drug effectiveness law and endorses FDA action to control entire classes of products by regulations rather than to rely only on time-consuming litigation. Fines Enhancement Laws of 1984 and 1987 amend the U S code to greatly increase penalties for all federal offences.

In India the Private Commercial Drug Testing laboratories are subjected to licensing and periodic audit by Regulatory Authorities, but Government Testing Laboratories both at Central and State level, are virtually exempted (?) from such audit. It is pertinent to highlight that test reports of these Government Laboratories, if adverse, form the basis of initiating departmental and/or criminal action against the concerned under the provisions of Law.

Let these Government Laboratories, including the CDL/CDTL be subjected to audit by outside private competent agencies and laboratories qualify may be authorized to test and issue test reports for that particular class of drug(s) and/or cosmetic(s) for which it has been found equipped and supported by well trained expert staff. This practice be continued every year. These qualified labs. be notified & Test Reports issued by such laboratories for approved class of drug(s) and/or cosmetic(s) be only considered valid under the ‘Act’/Rules.

In India, the Drug Enforcement Laws are under severe review and further major amendments are awaited in near future. After 1982, various provisions of Drugs & Cosmetics Act 1940 and Rules 1945 made there under are either already amended or widened. The import registration is brought into and the license fee to manufacture for sale and also for sale domestically is increased exorbitantly, the list of banned fixed dose combinations is exhaustive, the cGMP as schedule M is revised. More so new stringent penal provisions, minor financial penalties and compensation (first time) have been notified in the Drugs and Cosmetics (Amendment) Act 2009.(www.cdsco.nic.in)

In India Medium and Small Pharma Industrial units have been the target of MNC’s and LSI with an aim to exclude them from the business. To achieve this goal various gimmicks, illustrated below, were adopted, since the year 1999, in corroboration with those in power:

1.      Marketing of Generics by MNCs’ and LSI
2.      Incorporation of irrational eligibility criteria for participation in Government Tenders for procurement of medicines viz  i) Requirement of WHO GMP certification, which though ultimately  turned down by Hon’ble Supreme Court.still forms part of few domestic tender conditions; And ii) Minimum Annual Turn over of ranging from Rs. 1.0 cr. to 50.0 cr.
3.      Enhancement of licence fee from few thousand to few lacks
4.      Enforcement of Revised Schedule ‘M’
5.      Notification of Dr. Mashelkar committee, without proper and effective SSI representation and with pre-determined end result.
6.      Manipulation/ Highlighting Test Reports of Govt. Analysts
7.      Creation of Interstate business rivalry
8.      Levy of Excise duty on Maximum Retail Price
9.      Creation of Excise/Tax Free Zones
10.Notification of Amendment to Drugs and Cosmetics Act, based on recommendations of Mashelkar Committee Report, incorporating  stringent penal provisions such as:  i)  enhancement of punishments u/s 27 of the ‘Act’;  ii) section 32 any gazetted officer of Central or State Governments authorized in writing could also prosecute ;  iii)  section 36AC (1) (a): offence relating to adulterated or spurious drug and punishable under clauses (a) and (c) of sub section (1) of section 13, clause (a) of sub section (2) of section 13, sub section (3) of section 22, clause (a) and (c0 of section 27, section 28, section 28A, section 28B and sub sections (1) and (2) of section 30 and other offences relating to adulterated drugs or spurious drugs, made cognizable  (iv) section 36 AC (b):  Offences cognizable u/s 36AC(a) are made non bailable. (offending sections being reproduced below)

As a result of continuous follow up by the Industry, particularly SME sector, the Government of India in the Ministry of Health issued Directive to States/UTI’s under section 33-P of the ‘Act’ as “Guidelines for taking action on samples of drugs declared spurious or Not of Standard Quality in the light of enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008”

11.Enforcement of “Good Laboratory Practices” (Excluding the Govt Testing   labs and CDL/CDTL) 

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