NEW DELHI: India’s regulatory framework has a specific provision to grant emergency use, the Ministry of Health said on Tuesday. Responding to concerns that there may be a shortage of clauses in the support law for granting temporary licenses for Kovid-19 vaccines in the country
Health regulator Rajesh Bhushan said: “The regulatory frameworks of all countries do not refer to emergency use. This means that a particular country allows such approval and is different from regular market approval.”
“There is a specific provision for emergency use in India’s regulatory framework, but this phrase is not used,” he said.
Bhushan said the new ugs provisions and the Clinical Trials Rules, 2019, specify that, under special circumstances, restriction, abbreviation, omission or postponement of data, including local clinical trial data, may be considered for approval. “This is our law. Similarly, other countries also have their own legislation, ”he said. The government says that if the National Drug Controller is considering three applications for emergency use and any decision is based on a scientific assessment of the safety, efficacy and immunogenicity of the vaccine, there is hope that one or more vaccines will soon get the green signal.
The government has said it will undertake an in-depth and rigorous review of regulatory data, urging citizens to trust the country’s institutions. Niti Aayog, Member (Health) and Kovid-19 Dr VKK, head of the National Expert Group on vaccine administration, said.


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