Mr Rajiv Nath, forum coordinator of AIMED.
As three states - Andhra Pradesh, Maharashtra and Gujarat - are racing ahead to establish exclusive world class medical device manufacturing parks, Association of Indian Medical Device Industry (AIMED), the apex body of medical device manufactures in the country has recommended eight key policy measures which must be rolled out to ensure the financial viability of these parks as well as to make India a super international hub for medical device manufacturing.
AIMED recommendations range from tariff corrections to a new regulatory regime. Specifically AIMED has urged the government both at the Centre and states to ensure the following:
(i) A separate Medical Device Regulatory Act and separate Rules with IHPRA - Indian Healthcare Products Regulatory Authority rather than proposed ongoing amendment to D&C Act with compliance audits by 3rd party certification and have a mandatory compliance and regulatory framework built on soon to be launched QCI certification to ensure Patient Safety.
(ii)A medical device export promotion and India's first Import substitution council - MEDISEXPC
(iii)A dept for Medical Devices, a Separate Ministry for Healthcare products to act as facilitator and regulator and coordinated plan between Central Government and State Governments to aid existing manufacturing clusters and new medical device parks.