The Central Drugs Standard Control Organisation (CDSCO), the National Regulatory Authority of India (NRA), and associated institutions have been confirmed to meet the World Health Organization (WHO) published indicators for a functional vaccine regulatory system. This conclusion was reached by a team of international experts led by WHO (HQ) in Geneva after a comprehensive review of India’s vaccine regulatory system from September 16 to 20, 2024.
Vaccines are assessed on three basic parameters: safety, efficacy, and quality. WHO has set global standards for vaccine quality assurance through tools, guidelines, benchmarking of NRAs, and the prequalification of vaccines. The recent WHO NRA re-benchmarking exercise aimed to assess the regulatory system in India, measure the system’s maturity, and compare it against the WHO Global Benchmarking Tool (GBT) Version VI. The Indian system was previously benchmarked in 2017 against GBT Version V. Despite raised bars in criteria with GBT VI, India was declared functional across all core regulatory functions and retained Maturity Level 3, with the highest marks in several functions.
Union Health Secretary Punya Salila Srivastava remarked, “The Central Drugs Standards Control Organization, in collaboration with WHO, has made exemplary efforts towards this achievement. India is one of the main players in the pharmaceutical industry worldwide and is known for its affordable vaccines and generic medicines.” She congratulated all teams involved and reemphasised the strength of India’s regulatory system and its commitment to supplying quality products globally.
Dr Roderico H. Ofrin, WHO Representative to India, stated, “The WHO plays a pivotal role in supporting countries in strengthening their regulatory systems, and promoting equitable access to quality, safe, efficacious, and affordable medical products and health products. This is indeed a great achievement, and we would like to congratulate the Ministry of Health & Family Welfare and its affiliated institutions.”
Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), highlighted India’s role as a significant vaccine producer, supplying vaccines to international organisations like UNICEF, WHO, and PAHO. He added, “National Regulatory Authority of India meets the standards of the WHO NRA indicators (WHO Global Benchmarking Tool) on functional regulatory systems for vaccines.”
The benchmarking covered a range of regulatory functions including Registration and Marketing Authorisation, Vigilance, Market Surveillance and Control, Licensing Establishments, Regulatory Inspections, Laboratory Testing, Clinical Trials Oversight, and NRA Lot Release.
Dr Alireza Khadem, WHO Team Leader for the NRA Re-benchmarking, stated, “It will go a long way in reaffirming India’s role in global health, including the strength of its pharmaceutical sector and drug regulatory capacity. WHO had scaled up its technical support to India’s national regulatory authority over the past several years. This success is a culmination of intensive effort by the Health Ministry, including CDSCO, in collaboration with WHO, to implement a roadmap to strengthen capacity for regulation of vaccines.”
India has 36 major vaccine manufacturing facilities supplying to national and international markets, covering over 150 countries. This makes India a leading global supplier of vaccines. WHO’s Prequalification Programme (PQP) helps ensure access to vaccines that meet unified standards of quality, safety, and efficacy. A functional NRA is a prerequisite for the WHO prequalification of vaccines, enabling manufacturers to supply vaccines through United Nations procuring agencies.
The sustainability of gains made in regulatory capacity remains critical. To this end, the assessment team has drawn up a detailed Institutional Development Plan, outlining further steps to enhance India’s regulatory capacity over the coming years.
The WHO assessment included the Central Drugs Standard Control Organisation (CDSCO), State Drug Regulatory Authorities, the Central Drugs Laboratory in Kasauli, and other institutions involved in vaccine regulation and control.