WHO, in its assessment of the status of the Indian vaccine regulatory system against WHO NRA Global Benchmarking Tool (GBT) for benchmarking found Indian NRA as ‘functional’ with a maturity level of 4 or the highest level 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, maturity level 3 reflects systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends.
The assessment has been carried out by a WHO team comprising lead experts in different areas from WHO Headquarters Geneva, WHO India Country Office, experts drawn from the regulators of USA, Italy, Germany, Netherlands, Indonesia, Thailand and Egypt. The assessment has been done in respect of nine different functionalities and
India, as a large vaccine producing country, is currently supplying several vaccines to the UN agencies (UNICEF, WHO and PAHO). A fully functional NRA is a pre-requisite for WHO prequalification of vaccines. 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. The vaccine manufacturers can only apply for WHO vaccine prequalification if the NRA meets the standards of the WHO NRA published indicators i.e. WHO Global benchmarking Tool on functional regulatory system for vaccines.
The Global Benchmarking Tool (GBT) so developed has 63 indicators and 288 sub-indicators, out of which 150 are critical . The result reflects the growing maturity of the Indian NRA emanating from a concerted effort by the Government in consultation WHO to build capacity and capability of the National Regulatory Authority over last several years.