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3 Covid-19 vaccines under active consideration by the drug regulator: Government | India News

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NEW DELHI: India’s regulatory framework has a specific provision for granting emergency use authorization (USA), the health ministry said on Tuesday amid concerns that there are no adequate regulatory clauses in the drug law. to support said temporary license for the Covid-19 vaccine in the country.
“Not the regulatory framework of all countries mentions the phrase emergency use authorization. That does not mean that a specific country does not have an enabling provision to grant an approval that is early and that is different from a regular approval of the market, ”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 said.
The 2019 New Drugs and Clinical Trials Rules clearly specify that in specific special situations, relaxation, abbreviation, omission or deferral of data, including data from local clinical trials, may be considered for approval, Bhushan added. .
“This is our law. In the same way, other countries also have their laws, ”he said.
The government said that while the national drug regulator is actively considering all three applications for emergency use and any decision will be based on a scientific evaluation of the safety, efficacy and immunogenicity of the vaccines, one or more vaccines are expected to be approved. 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 create doubts about our regulator, our scientific institutions, about the National Technical Advisory Group on Immunization (NTAGI) ”, said Dr. VK Paul, member (health) of NITI Aayog and head of the National Group of Experts on Administration of Vaccines for COVID-9 said.
Three companies, Pfizer, Serum Institute of India and Bharat Biotech, have approached the drug regulator to request an emergency use authorization for their respective candidate vaccines. While Pfizer’s vaccine, which has already gained approval for such use in the UK, Bahrain, and some other countries, has not been tested at all in the Indian population, IBS has conducted bridging studies in India for Covishield, developed by Oxford University. and for which AstraZeneca is conducting extensive human trials in the UK and Brazil. Bharat Biotech’s homegrown Covaxin is undergoing phase 3 trials in India.

Times of India

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