Drugs and Cosmetics Bill in the works

The government has started drafting a new Drugs and Cosmetics Bill to regulate newer areas such as biological drugs, stem cells research, regenerative medicines, medical devices and clinical trial/investigation.

The Cabinet on Wednesday decided to withdraw Drugs and Cosmetics (Amendment) Bill, 2013, introduced in the Rajya Sabha on August 2013. The Bill had been examined by Parliament's standing committee, which had made a number of recommendations to further changes.

"The Cabinet 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," a government statement said.

Till date, the Drugs and Cosmetics Act, 1940, provided some form of regulatory framework for ensuring the quality, safety and efficacy of medical products, including of medical devices. But the government on Wednesday admitted that newer areas such as biological drugs, stem cell research, regenerative medicines, etc, cannot be effectively regulated under the existing law.

The Union health ministry has, accordingly, undertaken an exercise at two levels - to frame separate rules under the existing Act for regulating medical devices; to bring out separate legislations for regulating sectors such as drugs, medical devices and cosmetics. "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 been commenced," the government's statement said. "Keeping in view the objective of Make In India, 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."

India is one of the largest manufacturers of pharmaceutical products in the world. The annual production of such products is in excess of Rs 2 lakh crore. Out of this, more than 55 per cent is exported.