Indian drugs regulators CDSCO and NRA met WHO standards for vaccine regulations
Oct 11, 2024
New Delhi [India] October 11 : The Central Drugs Standard Control Organisation (CDSCO), along with the National Regulatory Authority of India (NRA) and affiliated institutions, has been found to meet international standards for vaccine regulations set by the World Health Organisation (WHO), the Ministry of Health and Family Welfare said on Friday.
As per the statement, the WHO-led experts team approved India's vaccine regulatory system after an in-depth scientific review, conducted between September 16 and 20.
WHO has established global standards and benchmarks for assurance of vaccine quality through the development of tools and guidelines, benchmarking of the NRA and prequalification programmes of vaccines.
Safety, efficacy, and quality are three basic parameters of assessment of vaccines.
The WHO NRA re-benchmarking was aimed to assess and document the status of the India regulatory system in the area of vaccine regulation, re-benchmark the status of the India vaccine regulatory system against the WHO NRA Global Benchmarking Tool (GBT) and measure the maturity of the system, as per the statement.
India has been declared 'functional' against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI, the ministry said.
India's vaccine regulatory system was benchmarked in the year 2017 against the Global Benchmarking Tool (GBT) version V, which is now revised to GBT VI with raised bars and stringency in benchmarking criteria.
Speaking about this landmark achievement, Punya Salila Srivastava, Union Health Secretary, stated, "The Central Drugs Standards Control Organisation, 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."
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," he added.
India is a major vaccine producer that has 36 major vaccine manufacturing facilities. These vaccines are used for the national and international market (150 countries), which makes India a major vaccine supplier across the globe.
