Context:

Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare organised the 7th India-Japan Medical Product Regulatory Symposium.

More on the news

• The Symposium was successfully held at the Federation of Indian Chambers of Commerce & Industry (FICCI) Convention Hall, New Delhi on 10th July 2024. 
• This symposium aligns with the Memorandum of Cooperation (MoC) signed in December 2015 between CDSCO and its Japanese counterparts, the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical and Medical Devices Agency (PMDA). 
• This MoC, valid until December 2025, underscores a commitment to fostering collaboration in medical product regulations between the two nations.

Medical Device Industry in India

• The current market size of the medical devices industry in India is estimated at $11 Bn, India is the fastest growing medical devices market amongst the emerging markets.
• This sector enjoys favorable government policies, including permitting 100% Foreign Direct Investment (FDI) under the automatic route for manufacturing medical devices.

Central Drugs Standard Control Organisation (CDSCO)

• It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act 1940.

Major functions:

• Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.

Significance of the Symposium 

• India can learn from Japan's best practices in areas like clinical trials and post-market surveillance, leading to a more robust regulatory system.
• Streamlined regulations can expedite approvals for innovative devices, benefiting both patients and manufacturers. Harmonization can also ease global market entry for Indian-made devices.
• These benefits align with government initiatives like "Make in India" by promoting domestic manufacturing and potentially lowering healthcare costs. 
• Ultimately, the symposium paves the way for a stronger Indian medical device industry, improving patient access to advanced technologies.

Government Initiatives for medical device Growth 

• Production-linked incentives: Financial incentives attract investments and boost domestic production of high-tech medical devices.
• Development of Medical Devices Parks: Dedicated parks provide essential infrastructure and streamlined regulations, creating an attractive ecosystem for manufacturers.
• India’s first national Medical Devices Policy: This comprehensive policy focuses on affordability, innovation, workforce development, and regulatory improvements.