Indian pharmacopoeia standard used by 11 countries: Drugs Controller General of India (DCGI), Dr. Rajeev Raghuvanshi

The Drugs Controller General of India (DCGI), Dr. Rajeev Raghuvanshi, announced that 11 countries have already recognized Indian pharmacopoeia as their standard. He highlighted that India supplies drugs, vaccines, and medical devices to over 200 countries globally and is now approving, on average, 100 global clinical trials annually, reflecting the trust international research organizations and companies place in India’s regulatory system. Additionally, India's National Regulatory Authority (NRA) has been advancing with approvals for CAR T-cell therapy, mRNA vaccines, and software as medical devices, showcasing continuous enhancements in skills and capacity. Six countries have also been notified, from where products in five designated categories are eligible for approval in India.

In October, the Ministry of Health and Family Welfare confirmed that the Central Drugs Standard Control Organisation (CDSCO), in collaboration with the National Regulatory Authority of India (NRA), meets international vaccine regulation standards set by the World Health Organisation (WHO). Following an in-depth review conducted by a WHO-led team between September 16 and 20, India’s vaccine regulatory system was approved. The WHO re-benchmarking process assessed India’s regulatory system against its Global Benchmarking Tool (GBT), ensuring compliance with global standards. Declared 'functional' across all core regulatory functions of WHO’s GBT Version VI, India is a major vaccine producer with 36 manufacturing facilities, supplying vaccines to 150 countries worldwide.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.