Hospitals and clinics can now purchase Covid-19 vaccines — Covishield and Covaxin but these will not be available at medical stores for general public, as per the condition put by the India's drug regulator, Drugs Controller General of India (DCGI), on Thursday which granted regular market approval for the jabs for use in adult population.
Vaccination data has to be submitted to the DCGI every six months and updated on the CoWIN app.
Under the said conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting. Monitoring of adverse events following immunization will be continued.
“"The CDSCO has now upgraded the permission for Covaxin and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions," Union health minister Mansukh Mandaviya tweeted on Thursday.
The DCGI approval was granted under the New Drugs and Clinical Trials Rules, 2019.
The DCGI's approval came after the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on January 19 recommended granting regular market approval to the Serum Institute of India's (SII's) Covishield and Bharat Biotech's Covaxin for use in adult population subject to certain conditions.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had submitted an application to the DCGI on October 25, seeking regular market authorisation for Covishield. The 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. "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, 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.
