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Policy and regulations

The Drugs and Cosmetics Act is archaic. It needs a refresh.

Latest developments have exposed the inadequacy of the current regulatory framework for medical devices and delivery of drugs through e-commerce. Besides, the licensing and policy regimes need a thorough rethink to enhance the ease of doing business.
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26 Feb 2019 8 Mins Read 1 comments
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For almost eight decades, India’s pharmaceutical-manufacturing industry has been governed by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945 (collectively, D&C Act). Although the act has undergone more than 10 amendments relating to manufacturing of drugs, clinical trials, etc., it is now time for a comprehensive review. The D&C Act, among other things, governs
(except in special circumstances), which are otherwise common in M&A deals. For the country to achieve the target of being among the top three pharmaceutical markets in the world, India Inc. expects more support from the government. (The authors are partners at law firm J. Sagar Associates. The views expressed in this article are their personal opinion.)
For almost eight decades, India’s pharmaceutical-manufacturing industry has been governed by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945 (collectively, D&C Act). Although the act has undergone more than 10 amendments relating to manufacturing of drugs, clinical trials, etc., it is now time for a comprehensive review. The D&C Act, among other things, governs (except in special circumstances), which are otherwise common in M&A deals. For the country to achieve the target of being among the top three pharmaceutical markets in the world, India Inc. expects more support from the government. (The authors are partners at law firm J. Sagar Associates. The views expressed in this article are their personal opinion.)

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