Government to replace UPA’s drug regulatory bill

The Union Cabinet on Wednesday decided to withdraw the Drugs and Cosmetics (Amendment) Bill, 2013, which had been introduced in the Rajya Sabha. A Standing Committee of Parliament had made a number of recommendations for changing the provisions of the Bill. 

The regulatory framework for ensuring quality, safety and efficacy of medical products including medicines, medical devices, in-vitro medical devices, stem cells, regenerative medicines, clinical trials was provided for in the Drugs and Cosmetics Act, 1940. 

“Keeping in view the role of the sector in managing public health, the Union 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 or investigation cannot be effectively regulated under the existing law,” an official statement said.

Keeping in view the objective of ‘Make in India’, it has now been decided to comprehensively review the existing law with two objectives — to facilitate the ease of doing business and substantially enhance the quality and efficacy of our products, it said.“The Health Ministry has undertaken an exercise at two levels namely — first to frame separate rules under the existing Act for regulating medical devices and second to bring out separate legislations for regulating medical devices, drugs and cosmetics,” the statement said.

Government on Wednesday approved a Rs 6,000 crore special package for textiles and apparel sector to create one crore new jobs in 3 years, attracting investments of USD 11 billion and generating USD 30 billion in exports. 

The measures approved include additional incentives for duty drawback scheme for garments, flexibility in labour laws to increase productivity as well as tax and production incentives for job creation in garment manufacturing. The decision was taken at a meeting of the Union Cabinet chaired by Prime Minister Narendra Modi. 

“The Rs 6,000 package will result in additional investments worth USD 11 billion, creation of one crore additional jobs and increase in exports worth USD 30.4 billion which. We will overtake Vietnam and Bangladesh in garment exports within next three years if we properly implement the package,” Textiles Secretary Rashmi Verma told reporters here.