In a bid to make it easier for pharma firms to do business and to improve the safety and efficacy of locally produced drugs, the Union Cabinet on Wednesday decided to withdraw the Drugs and Cosmetics (Amendment) Bill, 2013, which had been introduced in the Rajya Sabha last year.
A Standing Committee of Parliament had made a number of recommendations for changing the provisions of the Bill. The Bill will be replaced with new measures keeping in mind advancements made in various fields including stem cell research and clinical trials in keeping with the Modi Government's 'Make in India' initiative.
The Cabinet chaired by Prime Minister Narendra Modi, has, keeping in view the role of the sector in managing public health, 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/investigation, etc. cannot be effectively regulated under the existing law, according to an official statement here.
Also, keeping in view the objective of 'Make in India' campaign, it has been decided to comprehensively review the existing law with two fold objectives viz. to facilitate the ease of doing business and substantially enhancing the quality and efficacy of our products, the statement added.
The Health Ministry, accordingly, "has undertaken an exercise at two levels --to frame separate rules under the existing Act for regulating medical devices and 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 draft notified shortly, work on drafting the new legislation has also commenced."
The regulations hold importance given that India is one of the largest manufacturers of pharmaceutical products in the world. The annual production of such products is in excess of ` 2 lakh crore. Out of this, over 55 per cent is exported to over 200 countries of the world including the developed nations. As such, the pharmaceutical sector in India plays a vital role in managing the public health in large number countries at a substantially lower cost, the statement said.