New Delhi|HL
With the aim to strengthening the drug regulatory system, government decided to withdraw a UPA bill from Parliament. It would be under the step of government’s ‘Make in India’ initiative to replace it with a new measure keeping in mind advancements made in various fields including stem cell research and clinical trials.
The Union Cabinet today 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.
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.
