Express Pharma

Drugs & Cosmetics Act, 1940: Recommendations for a revamp

The existing Drugs and Cosmetics Act of 1940 was formed during the pre-independence era. Since then, amendments have been made to the D&C Act and Rules 1940 and 1945. However, considering the ever-evolving regulatory requirements, industry stakeholders feel that there is a need to reframe the Drugs and Cosmetics Act to make it more well-defined and align it with global regulatory requirements. They believe that it will also help in streamlining drug regulatory affairs in India

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 Draft Rules to substitute existing Schedule M to bring in GMP on par with international standards

SW Deshpande, Former Joint Commissioner, FDA Maharashtra and Advocate Founder, PHARMALEX

In my opinion, the Drugs and Cosmetics Act is well-drafted and has been amended from time to time with major changes in 1982 and 2008. Rules have a number of amendments and Good Manufacturing Practices are upgraded by amending Schedule M and Medical Devices Rules 2017.