Govt to replace UPA drug regulatory Bill

The Union Cabinet has decided to withdraw the Drugs and Cosmetics (Amendment) Bill, 2013, which was 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.