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WHO Applauds India on National Regulatory Authority 100% Compliance

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World Health Organization has applauded India’s National Regulatory Authority which was declared “functional’ with a maturity level of 4, 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, maturity level 3 reflects systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends, said health minister J.P. Nadda, who has appreciated the ministry for the effort.

“The successful outcome of the WHO conducted assessment of the National Regulatory Authority (NRA) of India is a big boost to the Government’s efforts towards quality healthcare, for which the Government is committed to,” he said.

The Minister informed that WHO has termed the 100% compliance in the WHO assessment (benchmarking) of the Indian vaccine regulatory system as another ‘landmark achievement’. The previous WHO assessment (benchmarking) of the Indian vaccine regulatory system was conducted in 2012 during which institutional development plan (IDP) and the road map for strengthening the NRA were developed.

Pointing out to the introduction of newer vaccines in the country’s full immunisation basket through the nationwide introduction of pentavalent vaccine, and the phased roll-out of Rotavirus vaccine and Measles Rubella vaccine, Mr. Nadda stated that the Ministry is confident that India shall meet all its global commitments in the healthcare sector as a result of these focussed endeavours.

In addition, Mission Indradhanush has strengthened the full immunisation drive of the Government, the Health Minister stated.

WHO Gives Maximum Marks to India’s Vaccination System

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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.