ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

Drugs and Cosmetics ActSubscribe to Drugs and Cosmetics Act

Cleaning Up the Pharma Industry

For over 30 years pharmaceutical companies have been selling fixed-dose combination drugs with scant need to justify their efficacy, safety or rationality for use. The Government of India has finally banned 344 such drugs, though pharma companies have been able to obtain interim judicial stay orders. It is hoped that the courts take into account the serious public health implications of the sale of certain drugs and allow regulatory intervention banning uncertified combination drugs, including codeine-based cough syrups and various cold and flu drugs.

Regulation of Clinical Trials and the Need for Comprehensive Reform

The proposed amendments to the Drugs and Cosmetics Act, 1940 are inadequate to effect the fundamental changes that the existing regulatory regime is crying out for. A wholesale consolidation and re-enactment of the existing secondary legislation is better suited than piecemeal amendments to the task at hand.

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