"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
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
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.