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 prequalification of vaccines. One of the requirements to become eligible and retain prequalification 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.
- Maturity level 4 indicates good results and sustained improvement trends, while level 3 reflects systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends.
- The result reflects growing maturity of NRAI emanating from a concerted effort by Government in consultation with WHO to build capacity and capability of NRAI over last several years.
About National Regulatory Authority of India (NRAI)
NRAI comprises the Central Drugs Standard Control Organisation (CDSCO), State Drug Regulatory Authorities, Adverse Events Following Immunization (AEFI) and Pharmaco-vigilance Programme of India (PvPI) structures at the Central and States levels.