Task force pitches for separate vertical to regulate medical devices industry

An independent vertical to regulate and facilitate the medical devices industry, tax incentives, moderate penal provisions and curbs on import of second-hand equipment are some of the recommendations made by a task force set up by the government to boost domestic production.

The first such medical devices park will be promoted in Gujarat, followed by another one in Chengalpattu in Tamil Nadu, said Fertiliser and Chemicals Minister Ananth Kumar, while releasing the report of the “Task Force on Medical Devices Sector in India” here on Wednesday.

In five years, India, which imports 70 per cent of its requirement of medical devices worth Rs. 60,000 crore, such as stents and implants, will be ready to export, the Minister said, adding that “it was an irony that despite our capabilities in frontier technology — nuclear, IT, biotechnology and aerospace, we have not been able to produce enough commonly used medical devices.”

Kumar said while MSMEs in India were manufacturing such devices, these were primarily low-end and high-volume ones. “India needs to catch up with high-end medical devices, such as stents, implants, MRI, X-ray, scan, diagnostic equipment among others,” he added.

The task force, which finalised its recommendations in a “record” four months, while proposing a regulator for the medical devices industry, suggested that an independent vertical within the existing framework to facilitate single-window clearances and control prices.

“Once the proposed exclusion of medical devices from the definition of drugs under the Drugs and Cosmetics Act (and hence from the Drugs Price Control Order) is implemented, medical devices may be included separate from drugs in the Essential Commodities Act and regulated under a separate Medical Devices (Price Control) Order”, the report said.

Also, the Department of Pharmaceuticals should be renamed as the Department of Pharmaceuticals and Medical Devices, along with a separate post of a Director.

Kumar said “a separate Act of Parliament will be required to give the medical devices industry a legal framework,”, adding that a national list of essential medical devices on the lines of essential drugs is the need of the hour to make it affordable for the common man.