The World Health Organisation (WHO) on Friday said the National Regulatory Authority of India (NRA) and affiliated institutions meet the WHO Global Benchmarking Tool requirements for a functional vaccine regulatory system.
Some of the affiliated institutions include the Central Drugs Standards Control Organisation (CDSCO) and the Central Drugs Laboratory.
The decision was arrived at after a WHO-led team of international experts conducted a comprehensive review -- performed every couple of years -- from February 13 to 17.
The team that performed the review called it a "great achievement for India".
"This is indeed a great achievement and we would like to congratulate the Ministry of Health and Family Welfare and its affiliated institutions," said Alireza Khadem, WHO Team Leader for the NRA Re-benchmarking, Group Lead, Regulatory System Strengthening Team.
One of the requirements to become eligible and retain the prequalification status is to have the NRA assessed as functional against the WHO Global Benchmarking Tool. Safety, efficacy and quality are three basic parameters of assessment of vaccines.
The WHO has established global standards and benchmarks for assurance of vaccine quality by developing tools and guidelines, benchmarking of the NRA and prequalification programme of vaccines.
"India is one of the largest manufacturers and exporters of vaccines worldwide; this development further deepens our resolve to maintain the highest quality and efficacy of the products that are manufactured within our country and in this context, we look forward to strengthening our collaboration with WHO," said Health Secretary C.K. Mishra.
Henk Bekedam, WHO Representative to India, said: "It will go a long way in re-affirming India's role in global health, including the strength of its pharmaceutical sector and drug regulatory capacity."
The WHO had scaled up its technical support to the India's national regulatory authority over the past several years, said Bekedam, adding: "This success is a culmination of intensive effort by the Health Ministry."
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