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The successful WHO assessment giving maximum ratings to National Regulatory Authority (NRA) is a big boost to the Centre’s efforts towards providing quality healthcare, Union Health Minister JP Nadda today said. The Minister’s comments come after NRA- the coutry’s vaccine regulatory body- was recently given the maximum ratings by World Health Organisation for vaccine regulations. “The successful outcome of the WHO-conducted assessment of NRA is a big boost to the government’s efforts towards quality healthcare, for which it is committed,” he said.
WHO South East Asia Regional Director Poonam Khetrapal Singh wrote to Nadda congratulating him on the assessment. Singh said the assessment outcome will go a long way in strengthening global confidence in India’s medical products and give an impetus to ‘Make in India’ initiative. WHO has applauded the country’s NRA being 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.
Nadda said the result is due to hard work of all health functionaries who have collaborated with the ministry in its efforts. He said WHO has termed the 100 per cent compliance in its assessment as another “landmark” achievement. The previous WHO assessment (benchmarking) was conducted in 2012 during which Institutional Development Plan (IDP) and the roadmap for strengthening NRA were developed. “The Ministry is confident that India shall meet all its global commitments in the healthcare sector as a result of these focused endeavours.
“In addition, Mission Indradhanush has strengthened the full immunisation drive of the government,” the Minister said highlighting introduction of newer vaccines in the country’s full immunisation basket. 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 regulatory body assessed ‘functional’ against the WHO’s NRA indicators. The assessment has been carried out by a WHO team comprising experts in different areas from WHO Headquarters Geneva, WHO India Country Office, and those drawn from the regulators of USA, Italy, Germany, Netherlands, Indonesia, Thailand and Egypt.
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