Regulation for all medical devices from October 1, says DCGI

India is on course to introduce regulations governing all the medical devices in the country on October 1, Drugs Controller General of India Rajeev Singh Raghuvanshi said at iPhex 2023

India is on course to introduce regulations governing all the medical devices in the country on October 1.

Class A and B medical devices are at present being regulated. From October 1, regulations will be in place for the remaining medical devices, categorised under two more groups, the Drugs Controller General of India Rajeev Singh Raghuvanshi said here on Wednesday.

The DCGI, who was speaking at the 9th International Pharmaceutical Exhibition (iPhex 2023) in Hyderabad, said the regulations are aimed at quality control and to create a facilitating environment. An emerging sector, medical devices manufacturing is on the rise spurred by an upsurge in demand for many such products during the pandemic and the government’s make in India emphasis.

“The quality [now] is based on individual manufacturers... [with proposed norms] the whole industry will be regulated,” he said.

Earlier this year, the Central Drugs Standard Organisation had issued a circular setting the October 1 deadline for Class C and D non-notified medical devices to transition from the existing mandatory registration to a licensing regime. “It is suggested that the manufacturers/importers may apply for grant of manufacturing/import licence with all the requisite documents,” it had said.

Addressing the gathering and later responding to media queries, Mr. Raghuvanshi said amendments to the Drugs and Cosmetics Act are under discussions. Citing opportunities opening up in the backdrop of India aiming to grow the pharma industry, from existing $50 billion, to $100 billion by 2028 and more than $120 billion by 2030, he said quality of products will be essential to capitalise on them. “Everything will be knitted around quality,” he asserted.

iPhex 2023, a three-day event comprising meetings and exhibition, is being organised by the Pharmaceuticals Export Promotion Council of India (Pharmexcil), a body under the Union Commerce Ministry.