National Regulatory Authority of India (NRAI) has been given the maximum ratings by global health body World Health Organisation for vaccine regulations.
WHO completed the assessment of the status of the Indian vaccine regulatory system against WHO NRA Global Benchmarking Tool (GBT) and measured the maturity of the system in India.
The assessment has been done in respect of 9 different functionalities and Indian NRA has been declared ‘functional’ with a maturity level of 4 which is the highest level as per currently evolved definitions in respect of 5 functions, and maturity level 3 in respect of 4 functions.
While, maturity level 4 indicates good results and sustained improvement trends, level 3 reflects systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends, it said.
A fully functional NRAI is a pre-requisite for WHO prequalification of vaccines and one of the requirements to become eligible and retain prequalification status is to have the National Regulatory Authority (NRA) assessed as functional against the WHO published NRA indicators.
WHO Prequalification Programme, as such, facilitates access to vaccines that meet the unified standards of quality, safety and efficacy as well as programme needs.
A WHO-led team of global experts from several countries came to this conclusion at the end of comprehensive review from 13-17 February 2017.
The NRAI and affiliated institutions meet WHO Global Benchmarking Tool requirements for a functional vaccine regulatory system.
Indian Health Ministry and its affiliated institutions – Central Drugs Standards Control Organization (CDSCO), Central Drugs Laboratory, Kasauli, Pharmacovigilance Programme and Immunization Division, and other relevant institutions are engaged in the regulation, control and testing of vaccines.
India is one of the largest manufacturers and exporters of vaccines world-wide.
