Govt expert panel recommends regular market approval for Covishield Covaxin
New Delhi Jan 19 PTI An expert panel of Indias central drug authority on Wednesday recommended granting regular market approval to Covid vaccines Covishield and Covaxin for use in adult population subject to certain conditions official sources saidPharma companies Serum Institute of India SII and Bharat Biotech had submitted applications to the Drugs Controller General of India DCGI seeking regular market authorisation for their respective COVID-19 vaccines Covishield and Covaxin which are currently only authorised for emergency use in the countryPrakash Kumar Singh director government and regulatory affairs at SII had submitted an application to the DCGI on October 25 on this matterOn 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 informationIn addition to the successful completion of phase 23 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 responseSuch 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 saidIn an application sent to the DCGI a couple of weeks ago V Krishna Mohan whole-time director at the Hyderabad-based company submitted complete information regarding chemistry manufacturing and controls along with the pre-clinical and clinical data while seeking regular market authorisation for CovaxinBharat 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 applicationCovaxin and Covishield were granted Emergency Use Authorisation EUA on January 3The Subject Expert Committee SEC on COVID-19 of the Central Drugs Standard Control Organisation CDSCO which reviewed SII and Bharat Biotechs application for the second time on Wednesday has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions an official source saidThe recommendations will be sent to DCGI for final approvalLater in a tweet CDSCO said SEC of CDSCO has recommended for upgrade of covishield and covaxin status from restricted use in emergency situations to grant of new drug permission with conditions in adult population DCGI will evaluate the recommendations and give its decision During last weeks meeting the SEC had sought more data and information from the two companies PTI PLB ZMN
New Delhi Jan 19 PTI An expert panel of Indias central drug authority on Wednesday recommended granting regular market approval to Covid vaccines Covishield and Covaxin for use in adult population subject to certain conditions official sources saidPharma companies Serum Institute of India SII and Bharat Biotech had submitted applications to the Drugs Controller General of India DCGI seeking regular market authorisation for their respective COVID-19 vaccines Covishield and Covaxin which are currently only authorised for emergency use in the countryPrakash Kumar Singh director government and regulatory affairs at SII had submitted an application to the DCGI on October 25 on this matterOn 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 informationIn addition to the successful completion of phase 23 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 responseSuch 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 saidIn an application sent to the DCGI a couple of weeks ago V Krishna Mohan whole-time director at the Hyderabad-based company submitted complete information regarding chemistry manufacturing and controls along with the pre-clinical and clinical data while seeking regular market authorisation for CovaxinBharat 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 applicationCovaxin and Covishield were granted Emergency Use Authorisation EUA on January 3The Subject Expert Committee SEC on COVID-19 of the Central Drugs Standard Control Organisation CDSCO which reviewed SII and Bharat Biotechs application for the second time on Wednesday has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions an official source saidThe recommendations will be sent to DCGI for final approvalLater in a tweet CDSCO said SEC of CDSCO has recommended for upgrade of covishield and covaxin status from restricted use in emergency situations to grant of new drug permission with conditions in adult population DCGI will evaluate the recommendations and give its decision During last weeks meeting the SEC had sought more data and information from the two companies PTI PLB ZMN
