Separate rules for medical devices have been issued by India’s health ministry. Currently, med devices are regulated alongside pharmaceutical products in India applying the same set of rules for both. The Medical Devices Rules, 2017 would govern the manufacturing, quality and safety standards of a broad range of products, including medical equipment and in vitro diagnostics.

Device makers have long been pressing for distinct regulations for the sector. They argue that the current guidance under the Drugs & Cosmetics Act of 1940, which was created primarily for pharmaceuticals, often pose bottlenecks to India’s med device industry’s growth.  

The new device-specific regulations make an attempt to ease certain requirements in the existing rules. For instance, device makers can now have licenses that “shall remain valid in perpetuity.” This means licensees do not have to run around to get their licenses renewed every time. Once issued, they can continue holding the license by paying a retention fee before completion of the period of five years from the date of issue.

Likewise, the new regulatory document shows the requirement of clinical studies for devices has been cut down to two phases—a pilot study for an investigational medical device for the first time in human participants, and a pivotal trial on the basis of data emerging from pilot clinical investigation. Presently, med devices have to go through the same 4-phase clinical trials as pharmaceuticals. Also, no permission is required for conduct of academic clinical investigations on licensed medical devices if such a study is approved by the Ethics Committee.

The Medical Devices Rules, 2017 will take effect from January 1 next year.

SOPS for manufacturing
Along with separate legislations, India has plans to delink the devices industry from the pharma sector keeping in line with global practice, where med devices follow a distinct regulatory pathway. According to union minister of state for commerce, Nirmala Sitharaman, the government is considering to list med devices too among the high priority industries to facilitate local manufacturing.

“Like pharma has earned respect worldwide, I hope medical devices similarly earn this respect globally and achieve global manufacturing competitiveness. The medical device sector is now a part of the ‘25 Make in India’ campaign,” said Ms. Sitharaman at a recent industry gathering.

The measure would also help reduce the dependency on imports, she added. At present, India meets its medical devices requirement by importing more than 70% of the market size, which, some estimate  to be around $10 billion and growing.

Plans are underway for building public-funded Med Tech parks to provide facilities in the southern Indian states of Tamil Nadu and Andhra Pradesh. More tech parks are on the anvil across India.

Further, as an incentive to device start-ups, the government has decided to bear the cost of effluent treatment facilities at the manufacturing sites, reports said.
It is expected that providing such infrastructure support could bring down the manufacturing cost and make the sector globally competitive.

Device destination
To attract foreign capital to the fledgling devices industry, Ms. Sitharaman made it clear that “[the government] is here to do the hand holding and help the foreign investor know how to go about it.” She assured foreign investors in the medical devices sector that there is a red carpet awaiting them and not red tape. She also said there will be no undue delays as the newly implemented single window clearing mechanism will fast-track proposals.

Already, 100% FDI is allowed in the med devices sector. The minister said foreign investments started coming into the sector and her government would work closely with state authorities to identify the best possible options for investments.

Responding to another plea from local manufacturers, India is considering scrapping concessions in duty for imports of medical devices. To this end, the government is in the process of re-negotiating free trade agreements (FTAs) India signed with different nations. FTAs allow member countries to ship devices, especially medical electronics with zero duty.

Following a review last year, India had re-imposed import duty on medical devices to 7.5%. The duty concession, however, continued for some devices. The device industry is demanding to raise the tariff structure to 10% to stall imports. India is also looking at the possibility to form a ministry dedicated to pharma and medical devices, as a growing recognition of the growth potential in these sectors.

Clearly, the idea is to make India an attractive hub for med device start-ups.

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S. Harachand
Contributing Editor

S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com