By Ishank Katyal
American pharmaceutical giant Pfizer has sought India’s approval for the authorization of corona vaccine supply from the country’s drug regulator DCGI (Drugs Controller General for India) as per the sources.
In its application submitted on December 4, Pfizer India has got the 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.
Official sources in DCGI told NDTV: “Pfizer’s CT-18 application for grant of permission to import new drug (Covid vaccine) for sale in India is under process. As per New Drugs and Clinical trials Rules 2019, the application has to be decided within 90 days.”
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. Till date, such discretionary power has not been used.
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 third stage of trials.
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.