Pfizer, the US-based pharma giant, has sought approval from India’s drug regulator – the DCGI (Drugs Controller General of India) – for emergency use authorisation of its coronavirus vaccine. 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 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,” according to a news agency.
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.
The DCGI has “discretionary power to waive localised clinical trials for a vaccine”, officials say. Till date, such discretionary power has not been used.
