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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2014)

Does India Need More Drug Regulations?

Dr. M. D. Nair

Introduction: The Pharmaceutical industry is the most regulated industrial segment all over the World and rightly so since apart from the Food industry, there is no other sector which so heavily impinges on the life and welfare of human beings and animals. Formal legislation to regulate the Indian pharmaceutical industry was the Drugs & Cosmetics Act 1940 and the set of rules which came into force in 1945. In spite of several amendments to the Act to bring it on par with global standards, it has been generally believed that there are several lacunae in the provisions as well as implementation of the Act. This was further endorsed by the 59th report of the Parliamentary Committee on the Indian Pharmaceutical industry in 2012 which made scathing remarks on the functioning of the Central Drug Standards & Control Organisation (CDSCO) on several issues ranging from inefficiency, lack of transparency, nexus with the stake holders, allowing unauthorised clinical trials and marketing of new drugs, off label use of drugs, poor post marketing surveillance and pharmaco-vigilance, insufficient human resources etc. 

 

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