New Delhi: India’s drug regulator on Thursday gave regular marketing approval to the Covid-19 vaccines – Covishield and Covaxin- for use in the adult population, subject to certain conditions. Official sources gave this information. This approval has been given under the New Drugs and Clinical Trials Rules, 2019. Under the conditions, firms will have to submit data from ongoing clinical trials. Post-vaccination adverse effects will be monitored.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on 19 January accorded regular marketing approval to Covashield of Serum Institute of India (SII) and Covaccine of Bharat Biotech, subject to certain conditions. was recommended to do. After this, the Drug Controller General of India (DCGI) gave this approval. SII Director (Government and Regulatory Affairs) Prakash Kumar Singh had given an application in this regard to DCGI on October 25.
To this DCGI had sought more data and documents from the Pune-based company, following which Singh had recently submitted a reply with more data and information. The prevention of 19 in itself is a testament to the safety and effectiveness of the vaccine.”
In an application sent to DCGI, Hyderabad-based Bharat Biotech’s whole-time director V. Krishna Mohan, seeking regular marketing approval for Covaccine, provided complete information related to the vaccine.
Mohan had said in the application that Bharat Biotech International Limited (BBIL) had accepted the challenge of developing, producing, and clinically evaluating the vaccine (Covaccine) in India. Covaccine and Covishield were granted Emergency Use Authorization (EUA) on 3 January.
