American pharma giant Pfizer has sought approval from the country’s drug regulator – the DCGI (Drugs Controller General of India) – for emergency use authorisation of its coronavirus vaccine, say sources. The vaccine is ready to be rolled out in the United Kingdom and Bahrain. This is the first such request received by the DCGI amid the race to find a vaccine for the deadly virus, which has affected over 96 lakh people in India.
The drug regulator may give emergency approval if it is satisfied by the results of the trials conducted outside India, sources have added.
On Wednesday, the United Kingdom became the first western country to clear the Covid-19 shot developed jointly by Pfizer and German biotechnology partner BioNTech, which has reported an efficiency of 95 per cent in the third stage of trials.
In its application submitted on Friday, Pfizer India sought permission to “import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019,” sources have been quoted as saying by news agency PTI.