National Regulatory Authority of India meets WHO international standards for vaccine regulations

The Central Drugs Standard Control Organisation (CDSCO) and the National Regulatory Authority of India (NRA), in collaboration with WHO, have successfully demonstrated compliance with the World Health Organization's (WHO) established indicators for a functional vaccine regulatory system. An international team made this determination of experts following a comprehensive review of India's vaccine regulatory framework conducted from 16 to 20 September 2024. India’s vaccine regulatory system retains a Maturity Level 3, excelling in several core regulatory functions, including registration, vigilance, and oversight of clinical trials.

Ministry of Health and Family Welfare, Ms. Punya Salila Srivastava commended the CDSCO’s efforts, noting India's significant role in the global pharmaceutical industry, particularly in providing affordable vaccines and generic medicines. With 36 major vaccine manufacturing facilities, India is a key supplier to over 150 countries. The WHO Prequalification Programme aims to ensure that vaccines meet unified standards of quality, safety, and efficacy, and a functional NRA is essential for prequalification. The recent assessment results affirm India's commitment to enhancing its regulatory capacity, ensuring the sustainability of gains made, and further strengthening the vaccine regulatory framework through an Institutional Development Plan, as highlighted by WHO representatives.

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