The government is gearing up to withdraw the UPA government existing Drugs and Cosmetics Amendment Bill which was intended to strengthening the drug regulatory system. The move aims to facilitate the ease of doing business and include latest research in healthcare within the parameters of the legislation, the officials announced.

The UPA government introduced the ‘The Drugs and Cosmetics (Amendment) Bill, 2013’ in the Rajya Sabha in 2013. The decision to withdraw the drug policy was taken at a meeting of the Union Cabinet, chaired by Prime Minister Narendra Modi.

An official statement said that, "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."

“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.”

“ 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 and 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.

According to the Drugs and Cosmetics Act, 1940, it regulates only conventional pharmaceuticals, that account for over Rs 1 lakh crore of annual domestic sales. However, newly emerged segments such as stem cells, online sale of medicines, nutraceuticals and medical devices are continue to be outside the purview of the act.

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Nandini