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Covaxin, Covishield get conditional market authorisation from DCGI

The Drug Controller General of India on Thursday gave conditional market authorisation to Bharat Biotech’s Covaxin and Serum Institute of India’s (SII) Covishield vaccine. With this approval, the hospitals and clinics will be able to directly procure from the vaccine manufacturers.

According to the Health Ministry sources, the conditional market authorisation means that these will be available only for those who are above 18 years of age and that too not be sold at the retail shops.

“The first condition is that with this authorisation, these vaccines can’t be bought at local pharmacies or shops with or without the prescription. Only private hospitals and private clinics can buy them from the manufacturers. Secondly, the vaccines will be administered to those above 18 years of age and lastly, the hospitals and clinics will have to upload the administration of dose on the CoWIN platform,” a Health Ministry source said.

Data on safety
He further added that under the conditional market authorisation, the vaccine manufacturers will have to submit the data on safety every six months. In addition, the sources declined to comment on reports of price capping of Covishield and Covaxin at Rs 275. No decision has been taken on the price capping yet, the sources said.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) had recommended for upgradation of status for the vaccines from restricted use in emergency situations to grant of new drug permission with conditions in the adult population on January 19.

Commenting on receiving the conditional market authorisation, Adar Poonawalla, Chief Executive Officer of SII said, “we are delighted to receive the conditional market authorisation for Covishield from the DCGI. With this, our focus should be to reduce the gap between the second and third dose to six months, as it is done globally.” The Hindu BusinessLine

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