Highlights of the Bill
The Drugs and Cosmetics (Amendment) Bill, 2005 seeks to amend the Drugs and Cosmetics Act, 1940. It enhances penalties for certain offences and provides for special courts to try offences related to spurious and adulterated drugs.
- The CDA shall be the licensing authority for the manufacturing, distribution, sale, import and export of drugs and cosmetics. It shall also recommend to the central government standards for drugs and cosmetics, measures to regulate clinical trials, etc.
The 2007 Bill expands the definition of “drugs” to include medical devices. It also defines “clinical trial”, states that all clinical trials require the approval of the CDA, and prescribes penalties for any person violating this provision.
Key Issues and Analysis
The 2007 Bill does not mandate medical and scientific experts in the CDA. A member can be any person with special knowledge of and a minimum of 15 years professional experience in the pharmaceutical industry, public administration, finance or law.
The Mashelkar Committee made various recommendations with regard to strengthening the drug regulatory system and the problem of adulterated and spurious drugs. Whereas several of these recommendations are being implemented through these Bills, neither Bill addresses the recommendations related to strengthening drug regulation at the state level.
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