Drugs and cosmetics amendment bill withdrawn from Rajya Sabha

Newer areas like stem cells, regenerative medicines, medical devices and clinical trial cannot be effectively regulated under the existing law, claims the Cabinet

By Mridul Ganguly
Published: Thursday 23 June 2016

The annual production of pharmaceutical products in India is worth more than Rs 2 lakh crore

The central government, on Wednesday, withdrew the Drugs and Cosmetics (Amendment) Bill, 2013, which it had introduced in the Rajya Sabha on September 29, 2013.

The pending bill was supposed to replace the Drugs and Cosmetics Act, 1940, which regulates only conventional pharmaceuticals.

The Union Cabinet, chaired by the Prime Minister Narendra Modi, took the decision subsequent to the recommendation by standing committee. The Cabinet said that carrying out further amendments may not be appropriate, as newer areas like biological, stem cells and regenerative medicines, medical devices and clinical trial cannot be effectively regulated under the existing law.

The process of drafting a new bill is under process.

The new bill, as per media reports, will focus on developing legislations to boost the ease of doing business.

For this, the Ministry of Health and Family Welfare (MoHFW) has undertaken an exercise at two levels: 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.

In a statement, the cabinet said, “In order to leverage the comparative cost advantage, the demographic dividend and the advantage in information technology, the Indian medical products sector is poised for exponential growth in the near future and it would besides meeting the domestic demand, has the potential to become an international hub for manufacturing these products and attracting investment in the sector.”

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 per cent is exported to over 200 countries.

The statement added that the pharmaceutical sector in India plays a vital role in managing the public health in large number countries at a substantially lower cost. This, along with the need to create affordable healthcare for people of the country mandates the need for a new law, it said.

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