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Even as the Union Health Ministry is all set to come out with the new Drugs, Medical Devices & Cosmetics Bill, replacing the over 85-year old Drugs and Cosmetics Act, 1940 to regulate the import, manufacturing, distribution and sale of drugs, medical devices and cosmetics in the country, 11 associations representing medical devices, healthcare, clinicians and NGOs have jointly appealed to the Union Health Minister J P Nadda to re-examine the Bill. The associations have cautioned the government that the revised draft bill, released recently, continues to treat medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering, and regulatory distinctions. This approach, they argue, will undermine India’s ambition to become a global medical device manufacturing hub, reduce import dependency, and achieve exports exceeding Rs.1,00,000 crore in the next 5-7 years. They have now urged the Health Ministry to enact a standalone Medical Devices Act as India’s medical devices sector cannot be shackled by a pharma-centric law. They argue that medical devices are engineering products, not pharmaceuticals and India must adopt smarter, risk-proportionate regulation that safeguards patients while fostering innovation. It is now clear that retaining medical devices under the same law as Drugs will create complex compliance requirements, particularly for MSMEs, potentially hurting competition, innovation and increasing healthcare costs. 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.
While arguments and counter-arguments are flying thick and fast, the Union Health Ministry should now try to understand the pulse of the medical devices industry in the country as this sunrise industry has been clamouring for a separate Act, similar to the introduction of Food Safety and Standards Act for the food industry. Even though there are separate provisions for medical devices in the bill, the medical devices industry deserves a separate law as medical devices are essentially engineering products and while having commonality in terms of their usage with drugs or medicines, these form an entirely distinct category. It is obvious that the medical devices industry has a huge potential of investment of over Rs. 50,000 crore to meet the market of over Rs. 1,00,000 crore and the government should have made separate Act for the medical devices industry in the country. The current approach of keeping the medical devices under the drug regulations is restricting the industry in various levels as both are different in nature. The government should have heeded to the demands of the medical devices industry in the country. The medical devices industry is a sunrise sector in the country and the government should not have found wanting in acceding to the just demands of the sector. There are no two opinions about the fact that the medical devices industry in the country has been growing by leaps and bounds for the last some years. So, the ministry cannot afford regulation of medical devices by pharma experts and it is time that at the ground level the medical device regulations are dispensed with by qualified and well-trained Medical Device Officers to give a fillip to the medical device industry in the country. The government should appreciate the potential of the medical devices industry and formulate a separate legislation for medical devices which should have the provisions to transform the medical devices industry and bring about a medical device revolution in the country.
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