Medical Devices Regulation to Be Fully Enforced Starting October 1, States DCGI

Pharmexcil's 9th International Pharmaceutical Exhibition (iPHEX) featured Raghuvanshi's statement about regulation. Currently, A and B have been notified. C and D will be notified starting October 1

According to Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, all four categories of medical devices (A, B, C, and D) will be brought under regulation by October 1. Currently, only two groups (A and B) are being regulated, but the upcoming regulations aim to ensure quality in the production of medical devices.  

The Union Cabinet approved the National Medical Devices Policy, 2023 on April 26, with a focus on improving the sector's quality controls. The medical devices sector in India was estimated to be USD 11 billion (approximately Rs 90,000 crore) in 2020, accounting for 1.5% of the global medical device market.  

During the inaugural session of the 9th International Pharmaceutical Exhibition (iPHEX), organized by the Pharmaceuticals Exports Promotion Council (Pharmexcil), S V Veeramani, Chairman of Pharmexcil, highlighted the significant global reach of the Indian pharmaceutical industry, serving around 200 countries.  

Ravi Udaya Bhaskar, Director General of Pharmexcil, further praised the Indian pharmaceutical industry's contribution to global healthcare through the supply of quality and affordable generic medicines. India is widely known as the 'Pharmacy of the World' for its crucial role in healthcare worldwide.  

In previous editions of iPHEX, over 4,500 foreign delegates, including regulatory officials, public procurement agencies, journalists, and importers from more than 120 countries, along with 3,500 exhibitors and one lakh visitors, have actively participated in this prominent pharmaceutical exhibition.