New Delhi: India’s vaccine regulatory system has been deemed compliant with World Health Organization (WHO) standards following a comprehensive review conducted in September, a PIb release stated. The assessment, carried out by a team of international experts, signifies that India’s regulatory framework meets the WHO’s indicators for a functional vaccine regulatory system.
The review, which took place between 16 and 20 September benchmarked India’s system against the WHO’s Global Benchmarking Tool (GBT) Version VI, the latest and most stringent version of the tool. This evaluation, conducted under the WHO NRA re-benchmarking program, aimed to assess India’s progress in vaccine regulation since its last assessment in 2017 against GBT Version V.
India has achieved a significant milestone by retaining Maturity Level 3, the highest level of maturity, with top marks in several regulatory functions, highlighting the effectiveness of India’s vaccine regulatory system in ensuring the safety, efficacy, and quality of vaccines produced in the country. Dr. Roderico H. Ofrin, WHO Representative to India, congratulated India for its achievement and emphasized the significance of this recognition for India’s role in global health, including the strength of its pharmaceutical sector and drug regulatory capacity.
The WHO team, led by Dr. Alireza Khadem, praised India’s efforts in strengthening its regulatory capacity and highlighted the collaboration between the Ministry of Health, the Central Drugs Standard Control Organisation (CDSCO), and the WHO.