The Drugs and Cosmetics (Amendment) Bill, pending for almost three years, was withdrawn by the Cabinet on Wednesday.
“The Bill had been examined by the Standing Committee of Parliament which had made a number of recommendations for changing the provisions of the Bill,” an official statement said.
A senior official in the Ministry of Health and Family Welfare said a number of new products and market segments have to be accounted for by the laws governing the health sector, calling for a new law instead of an amendment.
“The Cabinet has, keeping in view the role of the sector in managing public health, 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, etc cannot be effectively regulated under the existing law,” the statement read.
It added that the law would be reviewed to facilitate “ease of doing business” and separate rules would be formulated for regulating medical devices and drugs and cosmetics.
Draft rules “After extensive discussions with all stakeholders, the draft rules for regulating medical devices have been prepared and will be draft notified shortly, work on drafting the new legislation has also commenced,” the statement said.