Categorise all medical devices as drugs: Panel

Categorise all medical devices as drugs: Panel

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India’s topmost advisory body on pharmaceuticals has recommended regulating all medical devices as “drugs” for better safety, quality and performance of the devices, ranging from syringes at one end to implants and pacemakers on the other side.

The Drugs Technical Advisory Board (DTAB) has agreed to notify all medical devices as drugs in its last meeting.

At the moment 23 medical devices are regulated as “drugs” — ranging from hypodermic needles and condoms to cardiac stents, heart valves and orthopaedic implants — under the law.

Moreover, in two separate notifications issued in December 2018 and February 2019, the Union Health Ministry brought another 12 devices under the same category from 2020 onward.

The new devices include nebuliser, glucometre, digital thermometer, X-ray, CT, MRI and PET scan machines among others. All implants too would be in the same class.

The agenda before the DTAB was to prepare a roadmap for the regulation of more than 5,000 types of medical devices, as only 35 received the government’s attention so far.

The board not only gave its go ahead for such a move, but also suggested suitable changes in the Drugs and Cosmetics Act, 1940 and Medical Device Rules 2017.

Besides, it approved nearly 450 new posts in a separate wing of the Central Drugs Standard Control Organisation to regulate the devices and setting up of five testing laboratories with 300 staff in the next five years to support the regulatory activities. All the recommendations, however, have to be approved by the government before they come into effect.

Meanwhile, the medical device industry thinks that the DTAB suggestions are perfunctory in nature and coming out with a new law on medical devices will be the right step going ahead.

“It’s imperative to have a separate law as devices are engineering items and not medicines - an X-ray machine by no stretch of imagination can be called a drug, so continued attempts to regulate devices as drugs is illogical and incorrect,” said Rajiv Nath, Forum Coordinator of AIMED (Association of Indian Medical Device Industry).

“Medical devices are generically different from drugs and can’t be treated as drugs in the long run. The government should institutionalise a suitable and exclusive legal framework for medical devices so that areas of quality, adverse events, compensation, prices, healthcare training and health technology assessment are comprehensively addressed,” added Pavan Choudary, chairman, MTaI (Medical Technology Association of India).