India’s vaccine regulatory body NRAI (National Regulatory Authority of India) was given the maximum ratings by the World Health Organisation (WHO) for vaccine regulations. The ratings were given by WHO after completing the assessment of the status of the NRAI system against WHO NRA Global Benchmarking Tool and measured the maturity of the system in India.
Need for assessment
India is one of the main players in the pharmaceutical industry worldwide and often is referred as pharmacy of the world.
India, as a large vaccine producing country, is currently supplying several vaccines to the United Nations agencies (UNICEF, WHO and PAHO). A fully functional NRAI is a pre-requisite for WHO pre-qualification of vaccines. One of the requirements to become eligible and retain pre-qualification status is to get assessed.
The assessment was done in respect of 9 different functionalities by a WHO team comprising lead experts in different areas from WHO Headquarters Geneva, WHO India Country Office, experts from several countries.
Based on it, NRAI was declared functional with a maturity level of 4 which is highest level as per currently evolved definitions in respect of 5 functions, and maturity level 3 in respect of 4 functions.
About National Regulatory Authority of India (NRAI)
The Central Drugs and Standards Control Organization (CDSCO) is the National Regulatory Authority (NRA) in India. CDSCO is headed by the Drugs Controller General (India) [DCG(I)].
It approves vaccines that are introduced in the country, grant permission to conduct clinical trials, registers and controls the quality of imported vaccines, as well as lays down standards for updating India Pharmacopoeia.
It also approves licenses as the Central License Approving Authority (CLAA) for the manufacture of vaccines, coordinates the activities of the States and advises them on matters relating to uniform administration of the Act and Rules. The Central Drugs Laboratory (CDL), Kasauli performs lot release for all imported vaccines as well as locally produced vaccines.