March 24, 2023

Covid-19 vaccine: Covaxin, Covishield get regular market nod, with some riders | India News – Times of India

NEW DELHI: Drug regulator DCGI on Thursday granted regular marketing authorisation to the two commonly used Covid vaccines — Covishield and Covaxin — for use in adults with certain conditions.
However, the vaccines will be available only under “programmatic setting” and all vaccinations have to be recorded on CoWIN. This means though the vaccines will continue to be available at both public and private centres that are registered under government’s CoWIN, the jabs cannot be bought in retail at a pharmacy or chemist.
The makers of both vaccines would have to submit data of overseas ongoing clinical trials of their formulations with due analysis every six months or earlier if available. So far, the two vaccines were under emergency use authorisation. While the vaccines were given approval based on limited data from ongoing clinical trials, the manufacturers had to submit safety and adverse events data to the regulator every 15 days. With the regular approval in place, manufactures can now submit such data once in six months.
While the government has not shared details on the pricing of the two vaccines yet, the regular market authorisation may also enable the government to bring them under price regulation, sources said.
The subject expert committee of the Central Drugs Standard Control Organisation had recommended for status upgrade for the vaccines from restricted use in emergency situations to grant of new drug permission with conditions in the adult population on January 19, 2022.
“The latest approval accorded by DCGI… indicates the promptness and timeliness with which the public response strategy and decision-making apparatus of the country has responded to the emerging needs during the pandemic,” the health ministry said in its statement.
“Conditional Market Authorisation” is a new category of market authorisation that has emerged during the current pandemic. The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines.

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