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Regulatory rules have clauses for approval of emergency use: Government | India News


NEW DELHI: India’s regulatory framework has a specific provision for granting emergency use authorization, the Health Ministry said Tuesday, responding to concerns that the drug law may lack clauses to support the license. of Covid-19 vaccines in the country.
“Not all the regulatory frameworks of the countries mention the phrase emergency use authorization. That does not mean that the specific country does not have an enabling provision to grant such approval which is anticipated and which is distinct from regular market approval, ”said Health Secretary Rajesh Bhushan.
“India’s regulatory framework has a specific provision for granting emergency use authorization, although this phrase is not used,” he added.
The 2019 New Drugs and Clinical Trials Rules clearly specify that, in special situations, relaxation, abbreviation, omission or deferral of data, including data from local clinical trials, may be considered for approval, Bhushan said. “This is our law. Likewise, other countries also have their laws ”, he added. The government said that while the national drug regulator was considering three applications for emergency use and any decision would be based on a scientific evaluation of the vaccines’ safety, efficacy, and immunogenicity, it was hopeful that one or more vaccines would receive the green sign soon.
Urging citizens to keep faith in the country’s institutions, the government said the regulator would carry out deep and rigorous scrutiny of the data. “The regulator is considering three vaccines and that is a very satisfactory development. We are facing the largest immunization program in the world. Do not raise doubts about our regulator, our scientific institutions or the National Technical Advisory Group on Immunization (NTAGI), ”said Dr. VK Paul, Member (Health) at Niti Aayog and Head of the National Expert Group on Vaccine Administration for Covid-19. , said.

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