Medical Plastic Data Service Magazine



Our 29th Year of Publication
Page  1 of 3


Cover Story



Mr K L Sharma
Former Jt. Secretary, Drug & Food Regulation
Government Of India

Shri K L Sharma with his four decades of experience in the Government of India as a public policy practitioner, including as a Joint Secretary, Ministry of Health & Family Welfare was instrumental in streamlining the processes and rationalizing rules for regulation of drugs, cosmetics, medical devices and clinical trials. This included framing of the Medical Devices Rules, 2017. During the process, he interacted and coordinated many deliberations with a number of associations and companies in the Pharma and medical device sectors.


He has authored the best selling book, “Healing The Pharmacy of The World” which includes the most pertinent facets of Indian Medical Device Sector, especially those relating to promotion of manufacturing and regulatory controls.


In this free-wheeling exclusive interview with the, “MEDICAL PLASTICS DATA SERVICE”, as a public policy practitioner of four decades, he shares the insider’s views and analysis highlighting critical issues like factors responsible for market growth (Domestic & Exports), ecosystem improvements required, need for a separate regulator, role of the Industry, harmonization of activities of various agencies, appropriateness of the incentives including production linked incentive schemes as announced by the GOI, need for medical device parks and importance of innovations in the medical device sector. Lastly he has suggested critical action points with a view to reinvigorating Indian Medical Device Industry.


How do you see the growth of the Indian Medical Device Industry both for domestic and international markets? Which will be the major factors responsible for the growth of this sector?


Post the onset of COVID-19, all eyes are now set on discovering India as the destination for manufacturing of quality medical devices for meeting the global requirements. The growing disenchantment with China, the manufacturing factory of the world on account of both the quality related issues and also the geo-strategic developments, posit India as the alternative global manufacturing base. With huge demographic dividend and the pool of scientific and technical personnel, India has this opportunity now knocking at its doors. The Central government and many state governments have made their intent clear on seizing this opportunity. However, transition from intent to actual delivery at the ground level will require the steely resolve and half hearted measures will not do. Inadequate responses will only result in squandering away the golden opportunity bestowed by providence on this country. It will require a new vision and also entail some tradeoffs. History is replete with examples where industry, on a cue from the governments, has outperformed its capacity despite major constraints including the size of the country. South Korea and Taiwan are two examples that have demonstrated it over last six decades. If they could it, India can certainly do it and do it better. The question is are we ready for it?


Can you please shed some light on the need for improving the Medical Device Industry ecosystem in India particularly highlighting the priority elements of the ecosystem?


For reaching the global scale it would be necessary to ensure the best quality of the made in India products. Becoming globally competitive both in terms of the quality and prices is not an option but a prerequisite for asserting out rightful place. The Industry realizes that there is no future for products that do not conform to the quality parameters. At the same time products have to be made available at prices that are less than the prices of products manufactured elsewhere. The scale can be increased only if accessibility and affordability are enhanced. The government on the other hand has come to realize that the Indian industry suffers from a serious cost disadvantage and it is necessary to bridge the gap. That is a sound basis for taking action to reboot the sector by creating a completely new ecosystem that does not carry the past baggage. This needs to be leveraged.


Medical Devices are an important part of healthcare management. While WHO has identified Availability, Accessibility, Appropriateness and Affordability as crucial “4 As” of Medical Devices, why are Medical Devices still included in the definition of Drugs in India?


The medical devices continue to be treated as drugs as the Drugs & Cosmetics Act, 1940 had been enacted keeping in view the provisions of the Government of India Act, 1935. The usage of the medical devices and their complexity at that point of time were nowhere closer to what it is today. The Government of India Act, 1935 had vested the provinces with much more authority than what would have been vested in them under the Constitution of India. The Drugs & Cosmetics Act, therefore, does not appropriately reflect the current constitutional provisions and developments that have taken place with the intersection of physiology, engineering, chemistry, artificial intelligence and machine learning, etc. The current drugs law is an anachronism of a bygone era that was based on the vestiges of the preindependence governmental architecture and scientific developments at that point of time. The constitutional fault-lines, archaic laws, absence of political will and commitment to reforms, half-hearted efforts at strengthening and reforming the drug regulatory architecture, bureaucratic inefficiency, poor implementation and a host of other factors have stifled the growth of the medical devices and pharmaceutical sectors and also permitted and encouraged many malpractices. It needs to be recognized that medical devices and drugs are essentially distinct and the former belong largely to engineering field. Their regulation calls for specific provisions. At the same time, in view of the fact that many combination therapeutic and diagnostic products combine drugs, devices, and/or biological products, there will be a need for effective coordination in the regulation of drugs and medical devices.

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