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.
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.”
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.
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.
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.
Also, vaccine experts in the country have been raising concerns about the logistical issues linked to the distribution of the Pfizer vaccine, which needs to be stored at a temperature of minus 70 degrees Celsius. Most vaccines in India can be stored at temperatures between 2 and 8 degrees.
Dr Gagandeep Kang, a vaccine expert, had earlier stated on Twitter, “This RNA vaccine needs ultracold storage. Not sure of BioNTech price, but Moderna is 37$ a dose. Which makes these vaccines a stretch for less resourced countries that will find them hard to deliver and expensive.”
In November, NITI Aayog member (Health) Dr VK Paul, who also heads the National Task Force on COVID-19, said sufficient doses of the Pfizer vaccine, as required for the Indian population, will not be available, but the government is looking at the possibilities and will work out a strategy for its procurement and distribution in case it gets the regulatory approvals.