The medical device sector is now to be included as one of the 25 priority sectors under the Make in India program. This would promote manufacturing and entrepreneurship, and create an enabling environment for investment.
The ministry of health and family welfare has also notified Medical Device Rules, 2017, on Jan 31, 2017. Till now, governed by the Drugs & Cosmetics Act, 1940, primarily meant for regulating the pharmaceutical industry, the sector can finally chart its own distinct and definitive course.
Currently, India imports over 70 percent of its medical device requirements in an annual market size of Rs.55,000 crore. Of the global supply chain of medical devices, India has a miniscule 1.3 percent share. Apart from import substitution, the recent policy change may facilitate to create global competitiveness through making India a manufacturing hub. With 60 percent of medical devices monopolized by 40 enterprises globally, focus on attracting this capacity into India would be a good beginning.
The government has also decided to bear the cost of effluent treatment plants and provide some basic facilities free of cost at the upcoming medical device parks in states, such as Andhra Pradesh, Haryana, Gujarat, and Maharashtra. This has the potential of bringing down the cost of medical device manufacturing by as much as 30 percent.
February saw National Pharmaceutical Pricing Authority fix a ceiling price for drug-eluting stents at Rs.29,600, and for bare metal stents at Rs.7260. Prices of stents had jumped exponentially by as much as 1000 percent from the time of production till they reached the patients, with hospitals in some cases enjoying abnormally high margins of 650 percent. Stents had been included in the National List of Essential Medicines in July last year, and were added in December 2016 to Schedule I of the Drug Prices Control Order, 2013, bringing the devices under price control. On the horizon could also be a price regulation for 14 more medical devices, including orthopedic implants, intraocular lenses, artificial heart valves, and consumables as syringes, needles, and catheters.