A draft national medical devices policy that could bring most medical devices within the ambit of price regulation while also outlining measures to boost local manufacturing of devices has been circulated by the Centre.
The proposal, which comes soon after a draft national pharma policy, marks continued government activism to reduce costs of medical care and control insurance payouts in view of steep treatment and hospitalisation expenses in the private sector. Currently, only a few critical medical devices are under indirect price control and 80% of all devices are imported products.
This poses a challenge for the government when regulating prices of even select devices like stents or knee implants as it has to base its calculations on landed price of imports.
The draft suggests creation of a national medical devices authority to promote local manufacturing as well as a separate pricing policy and a division under the national pharmaceutical pricing authority (NPPA) to regulate the price of such devices. “The government may announce a separate policy enunciating the principles for regulating prices of identified medical devices and implement the same by notifying a separate medical devices prices control order,” the draft says.
It suggests amending the Essential Commodities Act and the scope of NPPA’s functions and, instead, create a separate body – national medical devices authority – to boost growth of the medical devices sector. The medical devices market in India is estimated at around $7 billion, growing annually at around 15%. The department will also meet industry bodies on Thursday at New Delhi’s FICCI to discuss the draft policy.
However, industry executives said the department has re-circulated a 2015 draft policy without changes though the industry has submitted its several recommendations.