The regular market approval from Drugs Controller General of India (DCGI) to Serum Institute of India's (SII) Covishield and Bharat Biotech's Covaxin is expected soon after price fixation which is still underway, official sources told news agency ANI.
Earlier, news agency PTI had reported that an expert panel of DCGI had recommended granting regular market approval to COVID-19 vaccines Covishield and Covaxin for use in adult population subject to certain conditions.
Pharma companies Serum Institute of India (SII) and Bharat Biotech had earlier submitted applications to the DCGI seeking regular market authorisation for their respective COVID-19 vaccines Covishield and Covaxin, which are currently only authorised for emergency use in the country.
Prakash Kumar Singh, director (government and regulatory affairs) at SII, had submitted an application to the DCGI on October 25 on this matter.
On that DCGI had sought more data and documents from the Pune-based company following which Singh recently had submitted a response along with more data and information.
In addition to the successful completion of phase 2/3 clinical study in India, till now, more than 100 crore doses of Covishield vaccine have been administered to the people in this country and worldwide, Singh is learnt to have stated in the response.
"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.
Meanwhile, in an application sent to the DCGI, V Krishna Mohan, whole-time 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.
Bharat Biotech International Limited (BBIL) took up the challenge to develop, produce and clinically evaluate a vaccine (Covaxin), from the SARS-CoV-2 strains isolated from COVID-19 patients in India, Mohan had said in the application.
(With PTI inputs)
