Cabinet withdraws Drugs and Cosmetic (Amendment) Bill, 2013

The union cabinet on Wednesday decided to withdraw the Drugs and Cosmetic (Amendment) Bill, 2013, which was introduced in the Rajya Sabha on August 29, 2013.

Considering role of the sector in managing public health, the cabinet has 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, cannot be effectively regulated under the existing law, a cabinet statement said.

According to the cabinet, the bill was examined by the Standing Committee of Parliament which made a number of recommendations for changing its provisions. It was decided to bring in a comprehensive legislation later.

India is one of the largest manufacturers of pharmaceutical products in the world with annual production being in excess of Rs 2,00,000 crore.

Of this, over 55% is exported to over 200 economies of the world, including developed countries. As such, the pharmaceutical sector in India plays a vital role in managing public health in many countries at a substantially lower cost.

The government has said that the regulatory framework for ensuring the quality, safety and efficacy of medical products, including the medicines, medical devices, in-vitro medical devices and stem cells among others, is provided in the Drugs and Cosmetics Act, 1940.

"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," said the statement.

Besides meeting the domestic demand, the Indian health sector has the potential to become an international hub for manufacturing these products and attracting investment in the sector, said the statement.

The government has also said that keeping in view the objective of 'Make in India', it has been decided to comprehensively review the existing law with two fold objectives — to facilitate the ease of doing business and substantially enhance the quality and efficacy of Indian products.

"The Ministry of Health and Family Welfare has, accordingly, undertaken an exercise at two levels namely 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," said the statement.