India’s Drug Regulators Meet WHO Standards for Vaccine Regulations

The Central Drugs Standard Control Organisation (CDSCO), along with the National Regulatory Authority of India (NRA) and other affiliated institutions, has successfully met the World Health Organisation’s (WHO) international standards for vaccine regulations, according to the Ministry of Health and Family Welfare.

WHO Approval After Scientific Review

A team of WHO experts conducted an in-depth scientific review of India’s vaccine regulatory system from September 16 to 20. The assessment confirmed that India’s regulatory framework aligns with global standards, with the country declared ‘functional’ across all core regulatory functions of the WHO Global Benchmarking Tool (GBT) Version VI.

The WHO’s re-benchmarking process was aimed at evaluating and documenting the status of India’s vaccine regulation system against the updated WHO NRA Global Benchmarking Tool. This assessment focused on safety, efficacy, and quality, ensuring that India’s system met raised criteria set out in the revised GBT VI.

India had previously been benchmarked in 2017 under GBT Version V, but the latest evaluation required stricter adherence to more stringent global standards.

Union Health Secretary Punya Salila Srivastava hailed the collaboration between CDSCO and WHO, emphasizing India’s significant role in the global pharmaceutical industry, particularly in providing affordable vaccines and generic medicines.

Dr. Roderico H. Ofrin, WHO Representative to India, praised the achievement, noting WHO’s continued support in helping countries strengthen their regulatory systems to promote access to safe and affordable medical products.

India: A Major Global Vaccine Producer

India is home to 36 major vaccine manufacturing facilities, supplying vaccines both domestically and internationally to over 150 countries. This makes India one of the world’s largest suppliers of vaccines, playing a critical role in global health.

The achievement underscores India’s growing importance in the pharmaceutical industry and its commitment to maintaining high standards in vaccine regulation.