The Drugs and Cosmetics (Amendment) Bill, 2013 has been withdrawn by the Union Cabinet, which was introduced in the Rajya Sabha on 29.08.2013. The Bill had been examined by the Standing Committee of Parliament which had made a number of recommendations for changing the provisions of the Bill.
Keeping in view the role of the sector in managing public health, the Cabinet decided that it will not be appropriate to carry out further amendments in the present Act especially as newer areas of biological, stem cells and regenerative medicines, medical devices and clinical trial/investigation, etc. cannot be effectively regulated under the existing law.
Also, keeping in view the objective of make in India, it has been decided to comprehensively review the existing law with two fold objectives viz. to facilitate the ease of doing business and substantially enhancing the quality and efficacy of our products. The Ministry of Health and Family Welfare has, accordingly, undertaken an exercise at two levels namely (i) to frame separate rules under the existing Act for regulating medical devices; and (ii) to bring out separate legislations for regulating medical devices and Drugs and Cosmetics. While, after extensive discussions with all stakeholders, the draft rules for regulating medical devices have been prepared and will be draft notified shortly, work on drafting the new legislation has also commenced.
-Press Information Bureau