India's Vaccine Regulatory System
- 14 Oct 2024
In October 2024, India's National Regulatory Authority (NRA) and the Central Drugs Standard Control Organisation (CDSCO) was recognized for complying with the World Health Organization's (WHO) international standards for vaccine regulation.
Key Points
- Benchmarking Against WHO Standards: India’s vaccine regulatory system was evaluated by the WHO's Global Benchmarking Tool (GBT) Version VI, a stringent framework for assessing vaccine regulation.
- After a detailed review conducted in September 2024, India met all the key functional regulatory criteria.
- Maintaining Global Recognition: India retained Maturity Level 3, a significant achievement indicating the country’s regulatory system is equipped to ensure the safety, quality, and efficacy of vaccines for both national and international use.
- Collaboration and Effort: The evaluation involved close cooperation between the Ministry of Health and Family Welfare, CDSCO, and state drug regulatory authorities, supported by WHO.
- India’s Role in Vaccine Supply Chain: With 36 major vaccine manufacturing facilities, India supplies vaccines to 150 countries, making it a key player in global health.
- India's regulatory system ensures these vaccines meet international quality standards, supporting organizations like UNICEF, WHO, and PAHO.
- Sustaining the Achievement; WHO’s Prequalification Programme, essential for supplying vaccines through UN agencies, depends on a functioning NRA.
- To maintain this standard, India has developed an Institutional Development Plan in collaboration with WHO, aiming to enhance regulatory capacity in the coming years.
- Comprehensive Regulatory Functions: The evaluation covered crucial regulatory functions such as market authorization, licensing of establishments, vigilance systems, laboratory testing, and NRA lot release.
