Covid Vaccine: Covishield and Covaxin have been cleared by India’s drugs regulator for sale in the market, sources have said
New Delhi:
Covishield and Covaxin have been cleared by India’s drugs regulator for sale in the market, sources have said. However, this doesn’t mean the two COVID-19 vaccines will be available at shops soon though people would be able to buy them from hospitals and clinics, sources have said. Key details are awaited from the government, they said.
For emergency use, safety data has to be given the Drugs Controller General of India, or DCGI, within 15 days but for market approval the data has to be given to the regulator within six months.
The market sale of the two vaccines was approved under the New Drugs and Clinical Trials Rules, 2019.
Covaxin maker Bharat Biotech and Covishield maker Serum Institute of India, or SII, had given data of ongoing clinical trials to the regulator, which approved the market sale after a subject expert committee on COVID-19 on January 19 recommended approval.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had given an application to the DCGI on October 25 seeking regular market authorisation for Covishield. “Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy of the vaccine,” he had said.
In an application sent to the DCGI, V Krishna Mohan, Director at the Hyderabad-based Bharat Biotech, submitted complete information regarding chemistry, manufacturing and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin, news agency PTI reported.
The daily COVID-19 cases in India saw a marginal increase of 0.1 per cent but the positivity rate remained a concern as it jumped to nearly 20 per cent as the country reported under three lakh cases for the third consecutive day today.
India’s COVID-19 vaccination coverage has crossed 163.84 crore dose. At least 72 per cent of India’s adult population is fully vaccinated whereas around 52 per cent of children in the 15-18 years old age group have been inoculated with the first dose.
The active cases have decreased to 22,02,472 and now comprises 5.46 per cent of the total infections, while the national COVID-19 recovery rate has decreased to 93.33 per cent.
