"Regulation Will Help Growth of Medical Devices Sector In India"

Medtronic Inc., a global medical technology company provides therapies for the world's 20 most challenging diseases which include Parkinson's, cardiovascular disorders, spine injuries, diabetes and neurological problems. Milind Shah, managing director, heads Medtronic's Indian operations. He is responsible for the entire sales/marketing operations and expansion projects in South Asia. Armed with an MBA from IIM, Kolkata and B.Tech from IIT, Delhi, Shah served Henkel Group, as managing director prior to the present posting and worked in executive positions at 3M, Electro & Telecom group and NOCIL.

In an interview with Nandita Vijay of Chronicle Pharmabiz, Milind Shah provides an overview of the sector and says that regulatory approval for medical devices has to be made mandatory in India. Excerpts:

The Union government has notified 10 medical devices including cardiac and drug eluting stents as drugs that require central clearance prior to import, manufacture or marketing in the country. In your opinion what would be the impact of this new rule?

The notification will allow market to grow and help patients access the best available to diagnosis, monitor and recover at a faster pace. There is a need for regulation in India as globally all medical devices undergo stringent quality norms.

What would be the efforts by Medtronic's to seek approval from the Government of India for marketing its whole range of medical devices because these include not only cardiac stents, drug eluting stents, but catheters, intra ocular lenses, IV Cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements?

Medtronic already has approvals from US FDA and Europe CE and all its products are marketed in India. The American Chamber of Commerce, medical devices sector, Europe's UCOMED and the Confederation of Indian Industry and National Committee for Medical Equipment are in talks with the Government of India's ministry of health and family welfare to provide a list of the medical devices that require Central clearance prior to import, manufacture and marketing in the country. These dialogues would also ensure framing of guidelines for medical devices accreditation, in addition to establishment of required infrastructure to undertake product testing in India, certification and quality standard evaluation. The efforts to appoint a regulatory authority will fuel the growth of the sector.

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