Government Plans New Drugs & Cosmetics Bill

June 23, 2016

To regulate the newer areas like biological drugs, stem cells research, regenerative medicines, medical devices and clinical investigation, the government has initiated drafting a new Drugs and Cosmetics Bill with the intention to withdraw Drugs and Cosmetics (Amendment) Bill 2013, introduced in Rajya Sabha on August 2013.
The Drug and Cosmetics Act, 1940, however provided some form of regulatory framework for ensuring the quality, safety and efficacy of medical products and devices, but according to the government the newer areas mentioned above cannot be effectively covered in the existing law.

Union health ministry has divided the work plan in two levels i.e. to frame separate rules under the existing Act for regulating medical devices and to bring out separate legislations for regulating sectors such as drugs, medical devices and cosmetics.