November 28, 2022

Covishield, Covaxin to get full approval but won’t be retailing | India News – Times of India

NEW DELHI: The drug regulator’s subject expert committee (SEC) on Covid vaccines on Wednesday recommended full authorisation for the two widely used jabs — Covishield and Covaxin. However, the vaccines will continue to be available and administered only at the centres that are registered under the government’s CoWin platform, official sources said.
Once the Drugs Controller General of India gives the final approval, which is expected in a day or two, the manufacturers — Serum Institute of India and Bharat Biotech — will not have to submit safety data and data related to adverse events every 15 days for doses administered under the immunisation programme, a source said. Instead, they will have to do so once in six months as prescribed for other new drugs under the Drugs and Cosmetics Act.
“SEC of CDSCO has recommended upgrade of Covishield and Covaxin’s status from restricted use in emergency situations to grant of new drug permission with conditions in adult population. DCGI will evaluate the recommendations and give its decision,” an official said.
Asked whether individuals will now be able to buy the jabs from chemists, the official told TOI: “That will not be possible because the vaccine comes in a vial of 10 doses. Besides, every dose administered needs to be tracked under the CoWin system. Any centre administering the vaccine will have to be registered under the government’s CoWin platform.”
Allowing retail sale will create multiple challenges in monitoring production, availability and administration of the vaccines. The CoWin registration also enables the government to issue vaccination certificates.
TOI had reported on January 15 that Covid-vaccines will not be available in the retail market anytime soon although the regulatory expert committee may waive certain conditions that are part of the present regulatory approval. The conditions were imposed because the vaccines were given accelerated approval based on limited clinical trials data in an emergency pandemic situation.

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