NEW DELHI: The Centre on Wednesday decided to withdraw a UPA government Bill which was aimed at strengthening the drug regulatory system. According to an official statement, the intention behind withdrawal of the Bill is to facilitate the ease of doing business and include latest research in healthcare within the parameters of the legislation.
The decision to withdraw ‘The Drugs and Cosmetics (Amendment) Bill, 2013’ was taken at a meeting of the Union Cabinet, chaired by Prime Minister Narendra Modi. The Bill had been introduced in the Rajya Sabha. A Standing Committee of Parliament had made a number of recommendations for changing the provisions of the Bill.
“Keeping in view the objective of ‘Make In India’, it has now been decided to comprehensively review the existing law with two objectives – to facilitate the ease of doing business and substantially enhance the quality and efficacy of our products”, an official statement said.
The Bill aimed at amending the Drugs and Cosmetics Act, 1940 which provided a regulatory framework for ensuring quality, safety and efficacy of medical products including medicines, medical devices, in-vitro medical devices, stem cells, regenerative medicines and clinical trials.
“The Health Ministry has undertaken an exercise at two levels – first to frame separate rules under the existing Act for regulating medical devices and second to bring out separate legislations for regulating medical devices, drugs and cosmetics. The draft rules for regulating medical devices have been prepared and will be notified shortly, work on drafting the new legislation has also commenced,” it said.