Covishield & Covaxin get regular market approval

January 28, 2022 Hot from the Oven Valli Sarvani No comments

Covishield and Covaxin are major COVID-19 vaccines used in the vaccination of the country. They got approval for emergency use authorization last year.

Now, these two vaccines got approval from India’s drug regulator, the Drugs Controller General of India’s (DCGI) for the regular market. That means they got normal drug approval to be used in the adult population. Their usage is not restricted like in the past. However, their regular market approval is subject to some conditions.

For this, the manufacturers have to submit the data of their clinical data to the government. Besides, all vaccinations shall be recorded on the CoWIN platform. Also, monitoring on immunisation for adverse events shall be continued.

Health Minister Mansukh Mandaviya yesterday said that both Covishield and Covaxin got regular market approval to be available.

Both these vaccines will be available soon in private clinics for purchase. Those who need these vaccines can buy them at the prescribed price.

The price of each vaccine dose is fixed below ₹275 with a service charge of ₹150 so that these vaccines will be affordable to all people in the country.

Last week, the Subject Expert Committee (SEC) recommended granting regular market approval to both Covishield and Covaxin. After that, the DCGI gave its nod for the regular market approval of these vaccines.

Both Covishield and Covaxin got this approval under the New Drugs and Clinical Trials Rules, 2019. This approval enables citizens who want to get a booster dose to buy the vaccine at private clinics.

Meanwhile, the vaccination drive has been continuing in the country. So far, over 160 crore doses have been administered in the country. In addition to the first and second dose, a precautionary dose has been recommended for senior citizens and frontline personnel.

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