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Regulation for all categories of medical devices in India from Oct 1: DCGI

Speaking on the side-line of the 9th International Pharmaceutical Exhibition (iPHEX), Rajeev Singh Raghuvanshi said the regulations would ensure quality in the production of medical devices.

Regulation for all categories of medical devices in India from Oct 1: DCGI
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India is to introduce regulations to govern all the medical devices in the country starting on October 1. Presently, Class A and B medical devices are being regulated.

"In the medical devices, we are categorizing into four groups. Two groups (A and B) are already notified. C and D are left which will happen from October 1," said the Drugs Controller General of India, Rajeev Singh Raghuvanshi.

Speaking on the sidelines of the 9th International Pharmaceutical Exhibition (iPHEX), Raghuvanshi said the regulations would ensure quality in the production of medical devices. According to him, about 50% of the medical devices industry is still unregulated.

Talking about the importance of regulations, the DCGI further explained that in regulating the industry, the quality of entire ecosystem will improve and it will help boost revenues of manufacturers. “The amendments to the Drugs and Cosmetics Act are under discussions,” he said.

The Union Cabinet on April 26 had approved the National Medical Devices Policy, 2023 to give a thrust to the sector with quality controls. The Central Drugs Standard Organization had issued a circular earlier this year, stating the October 1 deadline for Class C and D non-notified medical devices to transition to a licensing regime.

Indian pharma exports were pegged at USD 25.39 billion in FY 23 and the target for the current year is USD 28 billion.

The size of the medical devices sector in India was estimated to be USD 11 billion (approximately Rs 90,000 crore) in 2020 and its share in the global medical device market is estimated to be 1.5%, an official release said earlier.

The iPHEX is organized by the Pharmaceuticals Exports Promotion Council (Pharmexcil) from July 5-7 in Hyderabad.