The Union cabinet on Wednesday announced the withdrawal of the Drugs and Cosmetics (Amendment) Bill, 2013 that was introduced in the Rajya Sabha during the UPA-2 regime in 2013.
The decision was made as the Cabinet decided 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.
Also, the Centre is in the process of drafting a new legislation altogether, keeping in view the objective of make in India.
In its June 6, 2016 order, the Central Drugs Standard Control Organisation (CDSCO) announced that it was re-visiting the Drugs and Cosmetics Act, 1940, to match up with the current regulatory requirements related to safety, efficacy and quality of drugs, medical devices and cosmetics.
The new Act will not only facilitate the ease of doing business but also look at substantially enhancing the quality and efficacy of Indian products.
The Union health ministry has started the process 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.
As a result of extensive decisions with all stakeholders, the draft rules for regulating medical devices are already prepared and will be draft notified shortly.
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, over 55% is exported to over 200 countries/economies of the world including the developed countries.
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 regulatory framework for ensuring the quality, safety and efficacy of medical products including the medicines, medical devices, in-vitro medical devices, stem cells, regenerative medicines, clinical trial/investigation, etc. is provided for in the Drugs and Cosmetics Act, 1940.