The Central Drugs Standard Control Organisation (CDSCO) has met safety, efficacy, and quality — indicators for a functional vaccine regulatory system by the World Health Organization (WHO), the Ministry of Health and Family Welfare said on Friday.
The announcement follows a comprehensive and in-depth scientific review of India’s vaccine regulatory system by a team of international experts from various countries, led by the WHO.
The team assessed the National Regulatory Authority (NRA) of India comprising the CDSCO, state drug regulatory authorities, central drugs laboratory, Kasauli; adverse events following immunisation (AEFI) structures at the Central and States levels, immunisation division, pharmacovigilance programme of India, and other relevant institutions engaged in the regulation, control, and testing 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,” said the ministry, adding that the country “retains Maturity Level 3 with highest marks in several functions”.
India is a major global vaccine producer that supplies medicines to 150 countries. It has 36 major vaccine manufacturing facilities.
WHO has established global standards and benchmarks for assurance of vaccine quality through the development of tools and guidelines, benchmarking of the National Regulatory Authority of India (NRA), and the prequalification programme of vaccines.
“The Central Drugs Standards Control Organization, 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,” said Punya Salila Srivastava, Union Health Secretary.
She also congratulated all the teams for their hard work in achieving this milestone for the country and reemphasised the strength of the Indian regulatory system.
Further, to sustain the benchmark, the team that completed the assessment in India also drew a detailed Institutional Development Plan to strengthen regulatory capacity in the country.