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Ramesh Shankar
Wednesday, September 20, 2023, 08:00 Hrs  [IST]

Recently, ten collective stakeholders of Indian healthcare industry, including the industry associations of medical devices manufacturers, patient interest groups and healthcare providers, have jointly demanded to the Union Health Minister Dr Mansukh Mandaviya to recall the New Drugs, Medical Devices & Cosmetics Bill, 2023 which was listed to be tabled in the recently concluded monsoon session of Parliament. The associations which raised the demand included such big names like the Association of Indian Medical Devices, Association of Diagnostics Manufacturers of India, Association of Healthcare Providers India, Surgical Dressing Manufacturers Association and All India Syringe & Needle Manufacturers Association. The Union Health Ministry has come out with the new Bill to replace the over 80-year old Drugs and Cosmetics Act, 1940 to regulate the import, manufacturing, distribution and sale of drugs, medical devices and cosmetics. In the joint letter, the industry associations have called for referring the new Bill to a new committee of medical devices regulatory experts under the chairmanship of either the Indian Council of Medical Research or the Department of Science and Technology or the Department of Biotechnology as medical devices are engineering products and not drugs. They have also called for participation of key stakeholders for discussing feedback from them and careful consideration of their suggestions before finalising the draft of the Bill and tabling it in Parliament. The domestic medical devices industry has also raised the concern that the new Bill is fraught with several loopholes and it will have serious repercussions for domestic medical devices industry. It is arguing that the Bill is totally divorced from the ground realities, and the survival of domestic medical devices manufacturers who have invested so hugely over the last some years will be in danger.

It is a fact that medical devices industry in the country at present is at its nascent stage and is trying to stand on its own feet. Earlier this year, the sector had got a tailwind in the form of the National Medical Devices Policy, 2023 which is expected to boost the sagging morale of the medical devices industry in the country. The policy has a vision for accelerated growth path with a patient-centric approach and to emerge as the global leader in the manufacturing and innovation of medical devices by achieving 10-12 per cent share in the expanding global market over the next 25 years. Such a policy was long pending as nearly 80 per cent of the medical devices currently sold in the country are imported, particularly high-end devices. Indian players in the space have so far typically focused on low-cost and low-tech products, like consumables and disposables, leading to a higher value share going to foreign companies. With the new policy, the government aims to reduce India’s import dependence from 80 per cent to nearly 30 per cent in the next 10 years, and become one of the top five global manufacturing hubs for medical devices by 2047. Now, with the introduction of the new Bill, there is concern among the industry that some of the provisions in the Bill will confuse the investors who have been putting up manufacturing capacity in the country in the last few years in response to PM's call for self-reliance in medical devices. The domestic medical devices industry is concerned that instead of providing progressive modern regulations benchmarked to latest best international regulations, the new Bill has been drafted by a committee of regulators seemingly misled by MNC lobby to suit themselves, without following due democratic pre-legislative processes and that continues to seek to regulate devices alongside drugs under the garb of a separate chapter for some provisions. The government should now recall the Bill and send it for wider consultation with all the stakeholders before tabling the Bill in the next session of Parliament.


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