According to JP Nadda, WHO’s recognition is a big boost to government’s efforts towards quality healthcare
The World Health Organisation (WHO) recently congratulated the Ministry of Health and Family Welfare (MoH&FW) for successful assessment of the country’s National Regulatory Authority (NRA). Nadda on receiving the recognition said, “The successful outcome of the WHO conducted assessment of NRA of India is a big boost to the government’s efforts towards quality healthcare, for which the government is committed to.” The minister stated that the ministry under the dynamic guidance and leadership of the Prime Minister Narendra Modi is poised for more such laurels in the healthcare sector.
WHO, in its letter to the Minister, has applauded the country’s NRA being declared ‘functional’ with a maturity level of four, i.e., the highest level as per currently evolved definitions in respect of five functions, and maturity level three in respect of four functions. While, maturity level four indicates good results and sustained improvement trends, maturity level three reflects systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends. Nadda termed this as the result of hard work of all the health functionaries who have collaborated with the Ministry in its efforts.
The Minister informed that WHO has termed the 100 per cent 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, 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, Nadda stated.
WHO accords high importance to equitable access to quality, safe, efficacious, and affordable medical and health products. In view of India being one of the main global suppliers of drug and biological medicinal products including vaccines, medical devices, and traditional medicines, and as it is supplying several vaccines to UN agencies, the ‘successful assessment will go a long way in strengthening global confidence in medical products from India’. WHO also notes that this shall ‘give an impetus to the Prime Minister’s ‘Make in India’ initiative.
A fully functional NRA is a pre-requisite for WHO prequalification of vaccines. One of the requirements to become eligible and retain pre-qualification status is to have the 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 pre-qualification if NRA meets the standards of WHO NRA published indicators i.e. WHO Global benchmarking Tool on functional regulatory system for vaccines.
Recently, WHO has completed the assessment of the status of the Indian vaccine regulatory system against WHO NRA Global Benchmarking Tool (GBT) for benchmarking and measured the maturity of the system. 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 the US, Italy, Germany, Netherlands, Indonesia, Thailand and Egypt. The assessment has been done in respect of nine different functionalities.
WHO, based on a robust benchmarking tool developed over years of consultation with various experts drawn from across the globe, carried out assessment of the National Regulatory Authority NRA of India comprising the Central Drugs Standard Control Organisation (CDSCO), State Drug Regulatory Authorities, Pharmaco-vigilance Programme of India (PvPI) and Adverse Events Following Immunization (AEFI) structures at the Central and States levels. The nine functions included in the tool are National Regulatory System; Registration and Marketing Authorization; Vigilance; Laboratory Access and Testing; Regulatory Inspection; Clinical Trial Oversight; NRA Lot Release; Licensing Premises; and Market Surveillance and Control. The Global Benchmarking Tool (GBT) so developed has 63 indicators and 288 sub-indicators, out of which 150 are critical. Earlier in 2012, NRA was assessed against seven functions and 181 indicators.
CK Mishra, Secretary, MoH&FW, also congratulated the entire team which have really put in very hard work to achieve this for the country.
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