medical devices and cosmetics bill: Bill seeking to regulate drugs, medical gear may be tabled in Parliament

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The Drugs, Medical Devices and Cosmetics Bill, which seeks to replace the 83-year-old Drugs and Cosmetics Act, may be introduced in Parliament in the ongoing session, people in the know told ET.

“Efforts are afoot to introduce the Bill in this session,” a person in the know told ET.

The Bill seeks to regulate the import, manufacture, distribution and sale of drugs, medical devices and cosmetics. It also seeks to ensure their quality, safety, efficacy, performance; clinical trials of new drugs; clinical investigation of investigational medical devices and clinical performance evaluation of new in vitro diagnostic medical devices, including Ayurveda, Unani, Siddha, Sowa-Rigpa and homeopathy drugs, medical devices and cosmetics.

The draft had been in the works for a long time but was posted on the ministry’s website last year. It received around 9,000 comments and suggestions.

However, according to the Association of Indian Medical Device Industry (AiMeD), adequate discussions had not been held and the draft Bill should be recalled.

The draft Bill had led to widespread apprehensions among industry stakeholders, who felt that their inputs had been overlooked. Industry leaders argued that key issues such as regulatory complexities, potential impact on innovation and the need for a conducive business environment had not been adequately addressed in the draft.”If the Bill is passed as is, the medical devices industry in India may be pushed into a supply chain crisis,” said Rajiv Nath, AiMeD’s forum coordinator. The association has been asking for a separate chapter on medical devices under the proposed law. “This was assured to us in 2016 and was in line with the Parliament committee recommendations, considering the huge potential of the industry,” added Nath.

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