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India is one of the largest manufacturers of pharmaceutical products in the world with the annual production valued at over Rs 2 lakh crore.
The government on Wednesday decided to withdraw a UPA bill from Parliament aimed at strengthening the drug regulatory system and replace it with a new measure keeping in mind advancements made in various fields including stem cell research and clinical trials that would be in step with the Modi government's 'Make in India' initiative.
The Union Cabinet plans to withdraw the Drugs and Cosmetics (Amendment) Bill, 2013, which 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.
The regulatory framework for ensuring quality, safety and efficacy of medical products including medicines, medical devices, in-vitro medical devices, stem cells, regenerative medicines, clinical trials was provided for in the Drugs and Cosmetics Act, 1940.
"Keeping in view the role of the sector in managing public health, the Union Cabinet has 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 or investigation cannot be effectively regulated under the existing law," an official statement said.
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, it said.
"The Health Ministry has undertaken an exercise at two levels namely - first to frame separate rules under the existing Act for regulating medical devices and second 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 notified shortly, work on drafting the new legislation has also commenced," the statement said.
India is one of the largest manufacturers of pharmaceutical products in the world with the annual production valued at over Rs 2 lakh crore.
Out of the total production, more than 55 per cent is exported to over 200 countries, including the developed ones, helping them manage their public health care system at substantially lower costs.
"In order to leverage the comparative cost advantage, the demographic dividend and the advantage in information technology, the Indian medical products sector is poised for exponential growth in the near future.
"It, besides meeting the domestic demand, has the potential to become an international hub for manufacturing these products and attracting investment in the sector," the statement added.
The 2013 Bill had provisions for setting up of a Central Drugs Authority as an overarching body for regulation of drugs and cosmetics and sought to bring 17 critical drugs under central licencing.
The Ministry had put up the draft guidelines of the Drug and Cosmetics (Amendment) Bill, 2015 in the public domain in January this year inviting views on the legislation. According to reports, the Bill was expected to be placed before Parliament for passage during the Budget session.
Photograph: Reuters