Govt to withdraw UPA drug regulatory bill, come up with new

The government 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 trails that would be in step with the Modi government's 'Make in India' initiative.

The Union Cabinet on June 22 decided 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.