Hyderabad: Medical devices of all four categories (A, B, C, and D) will be brought under the regulation by October 1 and as of now only two groups (A and B) are being regulated, Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi said on Wednesday.
Speaking to reporters on the sidelines of the 9th International Pharmaceutical Exhibition (iPHEX) being organised by the Pharmaceuticals Exports Promotion Council (Pharmexcil) here, Raghuvanshi said the regulations would ensure quality in the production of medical devices.
“In the medical devices, we are categorising into four groups. Two groups (A and B) are already notified. C and D are left which will happen from October 1,” he said.
The Union Cabinet on April 26 approved the National Medical Devices Policy, 2023 to give a thrust to the sector with quality controls. The market size of the medical devices sector in India is 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 per cent, an official release had earlier said.
Earlier during the inaugural session of iPHEX, SV Veeramani, Chairman of Pharmexcil, highlighted that the Indian pharmaceutical industry has carved out a unique distinction in reaching 200 countries in the world.
He said the Indian pharma exports were pegged at USD 25.39 billion in FY 23 and the target for the current year is USD 28 billion.
Ravi Udaya Bhaskar, Director General of Pharmexcil, said the Indian pharmaceutical industry has contributed substantially to healthcare through the supply of quality, affordable generic medicines to nearly 200 countries and is popularly called as the ‘Pharmacy of the World’.
Bhaskar further said earlier all the eight editions attracted over 4,500 foreign delegates, including regulatory officials, public procurement agencies, journalists and importers from more than 120 countries, 3,500 exhibitors and one lakh visitors.
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