DCGI Grants Regular Market Approval To COVAXIN and Covishield, Vaccines Against Wuhan Virus

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The Drugs Controller General of India (DCGI) on the 27th of January, granted regular market approval to India’s two vaccines against the Wuhan virus, also known as COVID-19.

Notably, the Serum Institute of India (SII) manufactured Covishield and the Hyderabad based Bharat Biotech International Private Limited manufactured COVAXIN will now be available for the regular market.

The decision was taken by the DCGI, after considering the recommendations of a special expert committee (SEC.)  The committee studied the proposals of the SII and Bharat Biotech, asking for regular market approval for the two drugs, against the deadly Wuhah virus.  According to sources, the proposal was sent in October 2021, after the second wave of the Wuhan virus.

However, the granted approval came with certain conditions.  One of the major conditions of the regular market approval is that only clinics and hospitals would be allowed to procure COVID-19 vaccines. No chemical shops or drug stores would be eligible for purchasing the vaccines.  It will be available to the adult population of India at an affordable price. Although the expected price for drugs is Rs. 275 with Rs. 150 additional charges, a final amount is yet to be announced.

Meanwhile, all the hospitals and clinics need to submit the Wuhan virus vaccine data every six months to the DCGI.  They would also upload the purchase and sell data on the official website of CoWIN.

The approval came under the New Drugs And Clinical Trials 2019 Act.

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