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Covishield, Covaxin get sale approval in India

The two Covid-19 vaccines can be purchased by hospitals and clinics, but will not be available at pharmacies and drug stores

New Delhi: The Drugs Controller-General of India on Thursday granted regular market approval for the Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin for use in the adult population subject to conditions.

The two Covid-19 vaccines can be purchased by hospitals and clinics, but will not be available at pharmacies and drug stores. The vaccination data will have to be submitted to the drug regulator every six months and also updated on the CoWIN app. The market approval was granted under the New Drugs and Clinical Trials Rules 2019.

Union health minister Mansukh Mandaviya said that the government’s vaccination drive will continue as it is to provide first and second doses for all and a precautionary dose for senior citizens.

As Covid-19 infections, driven by the Omicron variant, are still raging, with 407 districts reporting a positivity rate of over 10 per cent, the Centre on Thursday extended the existing containment measures till February 28.

India reported 2,86,384 fresh Covid-19 cases and 573 deaths in the last 24 hours. The country’s positivity rate has shot up from 16.16 per cent to 19.59 per cent. The weekly positivity rate, however, is 17.75 per cent.

The health ministry said Omicron was now the dominant Covid variant. It said there are early signs of a plateau in the number of cases, with just the top 10 states contributing to 77 per cent of total active cases. It said the percentage of Omicron increased rapidly in December and January and the prevalence of the Omicron sub-variant called BA.2 is increasing in the community.

The ministry said Karnataka, Kerala, Tamil Nadu, Gujarat, Andhra Pradesh and Rajasthan were recording a high number of Covid cases. It, however, said there was a decrease in Covid-19 cases and positivity rate in Maharashtra, Uttar Pradesh, Delhi, Odisha, Haryana and West Bengal.

Union health ministry joint secretary Lav Agarwal said: “A clear trend in terms of fewer Covid-19 cases requiring oxygen-supported beds or ICU beds has been observed… Also, active Covid-19 cases and deaths are much lower during the present wave compared to earlier surges.”

Warning against any laxity in Covid-appropriate behaviour, Mr Agarwal said 400 districts reported over 10 per cent weekly Covid positivity while in 141 districts it was between five to 10 per cent in the week ending January 26. On the prevalence of Omicron, he said 1,292 cases of the “variant of concern” were found in genome sequencing in December, that rose to 9,672 in January.

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