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.
In its application submitted on December 4, Pfizer India has sought approval 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.
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 over 90 per cent.
For a vaccine to be allowed in India it must clear clinical trials here, and sources had earlier told NDTV neither Pfizer nor its partner companies had asked to hold such trials. However, the Drugs Controller General of India has “discretionary power to waive localised clinical trials for a vaccine”, officials added.
A day after UK’s go-ahead marked a “historic” moment, Pfizer said it remains “committed to engaging with the Government of India and explore opportunities” to make its vaccine against coronavirus available in the country.
Prime Minister Narendra Modi on Friday said “three indigenous vaccines are already in the final stages of trial. “Vaccines for COVID are likely to be ready within few weeks. Indian health agencies and manufacturers are working in tandem with global agencies. We are fully prepared for the roll out,” he said after an all-party meeting.
(With inputs from PTI)