Covaxin & Covishield can be bought at hospitals, clinics now, govt approves sale

Approval for sale in the market for the two COVID-19 vaccines is meant only for the adult population. It will not be available for purchase in the shops but only in hospitals and clinics

In its application to the DGCI, SII had said that the effective containment of COVID-19 infection is in itself “a testimony of the safety and efficacy of the vaccine”

People will soon be able to buy Covishield and Covaxin vaccines from hospitals and clinics as both have been cleared for sale in the market, said news reports.

Though the vaccines have been approved for sale by the Drugs Controller General of India or DGCI, this doesn’t mean the two COVID-19 vaccines can be purchased off the shelf at shops. They will only be available for sale from hospitals and clinics.

Union health minister Manuskh Mandaviya also tweeted about the market approval for the two COVID-19 vaccines on Thursday (January 27): “The @CDSCO_INDIA_INF [Central Drugs Standard Control Organisation (CDSCO)] has now upgraded the permission for Covaxin and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions.”

Moreover, the approval is only for adult population. And adverse events following immunisation will continue to be monitored as part of the conditions.

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The sale of two vaccines in the market has been sanctioned under the New Drugs and Clinical Trials Rules, 2019. A subject expert committee on COVID-19 had recommended the authorisation after Bharat Biotech and Serum Institute of India had submitted the data of their ongoing clinical trials to the regulator.

The subject expert committee on COVID-19 had given the green signal on January 19.

The SII had given an application to the DCGI on October 25 requesting for regular market authorisation for Covishield. In their application, the manufacturer’s representative had pointed out that the large-scale vaccination of the population with Covishield and the effective containment of COVID-19 infection are in itself “a testimony of the safety and efficacy of the vaccine”.

While the Hyderabad-based Bharat Biotech had in its application given detailed information on the vaccine’s chemistry, manufacturing and controls. It also submitted pre-clinical and clinical data.

India’s vaccination coverage has gone beyond 163.84 crore doses. 72 per cent of India’s adult population is fully vaccinated, and around 52 per cent of children in the 15-18 years old age group have been inoculated with the first dose.

The daily COVID-19 cases in India has seen a marginal increase of 0.1 per cent. But the 20 per cent positivity rate continued to be a cause of anxiety. The country reported under three lakh cases for the third consecutive day on Thursday.

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