New Delhi: The Ministry of Health & Family Welfare (Mohfw) said that the Central Drugs Standard Control Organisation (CDSCO), along with the National Regulatory Authority of India (NRA) and affiliated institutions, has been found to meet the World Health Organisation (WHO) published indicators for a functional vaccine regulatory system. A team of international experts from various countries, led by WHO (HQ) in Geneva, arrived at this conclusion following a comprehensive and in-depth scientific review of India’s vaccine regulatory system conducted from September 16 to 20, it said.
The health ministry further said “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 measuring the maturity of the system.” Safety, efficacy, and quality are three basic parameters of the assessment of vaccines. The 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 programme of vaccines.
India has been declared functional against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI. India’s vaccine regulatory system was benchmarked in the year 2017 against Global Benchmarking Tool (GBT) version V which is now revised to GBT VI with raised bars and stringency in benchmarking criteria, it said. The Union Health Ministry said India retains maturity level 3 with the highest marks in several functions.
Reacting to this landmark achievement, Punya Salila Srivastava, Union health secretary, said, “The CDSCO, 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 the teams for their hard work in achieving this milestone for the country and re-emphasised the strength of the Indian regulatory system and its commitment to supplying quality products worldwide to enhance health outcomes.