india

Updated: Oct 20, 2019 00:15 IST

The Union health ministry has come out with a draft notification that aims to regulate all medical devices in the country, both for human and animal use.

All devices, including instruments, apparatus, appliances and implants, whether used alone or in combination for various purposes like diagnosis, prevention, monitoring, treatment, alleviation of any disease, investigation, replacement or modification or support of the anatomy among others are included as per the draft. In all, 36 devices have been included in the draft.

Currently, only 23 medical devices are regulated under the Drugs and Cosmetics Act 1940.

The ministry is already working on a separate legislation to regulate medical devices. Till such time the new legislation is enacted, the health ministry has decided to bring all medical devices under the Drugs and Cosmetics Act.

The ministry put out the draft notification that makes it mandatory for all such devices to seek central drug standards control organisation (CDSCO) on Friday, October 18.

“In pursuance of sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1st day of December, 2019,” reads the draft notification.

The draft is in public domain for comments for a month since its notification.

The industry has welcomed the move.

“The Health Ministry’s proposal to regulate all medical devices will allow Indian patients access to quality medical devices, and also put a check on garage manufacturing. Bringing all medical devices under regulation has been a long-pending demand from the industry and it is encouraging to see the government taking cognizance of industry concerns,” said Pavan Choudary, director general and chairman, Medical Technology association of India (MTaI).

“The domestic industry would also benefit from this regulatory pathway, as compliance with global standards will open up access to global markets for more domestic manufacturers-and not just the big ones. This Global

harmonization will go a long way in encouraging foreign investments -facilitating Make in India. It will also boost FDI which had recently fallen drastically in this sector,” he added.