A World Health Organization (WHO)-led team of international experts has affirmed that the National Regulatory Authority (NRA) of India and relevant institutions meet WHO published indicators for a functional vaccine regulatory system.
The WHO NRA re-benchmarking assessment, conducted from 16-20 September 2024, was aimed at assessing and documenting the status of the India vaccine regulatory system and re-benchmarking it against the WHO Global Benchmarking Tool (GBT), updating the institutional development plan of NRA and other relevant institutions, and measuring the maturity of the system.
The assessment declared India’s vaccine regulatory system functional against the WHO Global Benchmarking Tool at Maturity Level 3. The last WHO benchmarking conducted in 2017 had also found India fulfilled the requirements to reach Maturity Level 3.
Dr Roderico H. Ofrin, WHO Representative to India, said, “This achievement will boost confidence, trust and reliance on India’s regulatory system. 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.”
A functional NRA is a criterion for WHO prequalification of vaccines. The WHO prequalification programme is aimed at facilitating access to vaccines that meet unified standards of quality, safety and efficacy, as well as programme needs. It is also a prerequisite for manufacturers to supply to countries through United Nations (UN) procuring agencies.
India is the third largest producer of vaccines by volume in the world, and 14th largest producer by value. India is one of the biggest producers of affordable vaccines, medicines and medical products in the world and is currently supplying lifesaving vaccines to several countries and UN agencies, including WHO, UNICEF, and Pan American Health Organization, among others.
World Health Assembly resolution (WHA67.20) on regulatory system strengthening emphasized the WHO mandate to support building regulatory capacity in Member States consistent with good regulatory practices, and promoting regulatory cooperation, convergence and transparency through networking, work-sharing, and reliance.