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India s drug regulator on Thursday granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, official sources said. The approval was granted under the New Drugs and Clinical Trials Rules, 2019. Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting. Adverse event following immunisation will continue to be monitored. The Drugs Controller ....
The lifting of emergency use authorisation makes availability of the vaccines easier and provides an opportunity for their entry into the distribution channels. ....
An expert panel of India's central drug authority today recommended granting regular market approval to Covishield and Covaxin, which are currently only authorised for emergency use in the country, subject to certain conditions, official sources said ....