Quality check for medical devices

A proposal to this effect was made at the drug consultative meeting on June 23 and 24. The meeting was attended by state drug controllers and the Drug Controller-General of India, Dr Ashwani Kumar. The Drug Technical Advisory Committee will decide on the proposal soon.

The medical devices will be notified under the Drugs and Cosmetics Act; a separate department will be set up for evaluating the devices. Up until now, drug regulation came under the Drug Controller-General.

Health Minister Anbumani Ramadoss says: “There was no quality check so far. Anybody could start manufacturing and marketing the products. So a definite need of quality control was felt as quality and suitability had to be ascertained.’’

Kumar says strict benchmarks will be followed. ‘‘This would mean all the devices have to be certified for use. The devices are important as they stay inside the body,’’ he said.

Heart devices under scanner

Medical devices are of two kinds: in vivo and in vitro (used outside the body). The proposed regulation will only cover in vivo devices initially.

These include heart devices like pacemakers, valves, stents — medicated and non-medicated — as well as catheters.

Implants for bone and hip replacement surgery are also included.