The union cabinet decided to withdraw ‘The Drugs and Cosmetic (Amendment) Bill, 2013’. It was introduced in the Rajya Sabha on August 29, 2013. The government has also said the objective of ‘Make in India’ been decided to entirely review the existing law with two objectives – to simplify the ease of doing business includes latest research in Indian healthcare and to enhance the quality and efficacy of Indian products
India is one of the largest manufacturers of pharmaceutical products in the world and the annual production of products is in excess of Rs. 2 lakh crore. Over 55% is exported to over two hundred countries of the world including the developed countries. The pharmaceutical sector in India plays an important role in managing the public health at a significantly lower cost.
The Bill intended at amending the Drugs and Cosmetics Act, 1940 which provided a regulatory structure for confirming quality, safety and efficacy of medical products which includes medicines, medical devices, in vitro medical devices, stem cells, regenerative medicines and clinical trials/investigation.
The Health Ministry and Family Welfare has undertaken an exercise at two levels
- First to plan separate rules under the existing Act for regulating medical devices
- Second to bring out separate legislation for regulating medical devices, drugs and cosmetics.
After extensive discussions with all stakeholders, the draft rules for regulating medical devices have been prepared and notified shortly to work on drafting the new legislation has also commenced.
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