Pfizer becomes first company seeks approval in India

New Delhi, 6/12: Pfizer, the American pharmaceutical giant, sought approval from the Drugs Controller General of India(DCGI), for emergency use against the coronavirus, as reported by sources. The vaccine developed by Pfizer in partnership with German pharma, BioNTech, has already been approved for use in the UK and Bahrain. Pfizer is the first company to request for approval to the DCGI and has claimed efficacy well over 90% in its clinical trials. 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 reported.

For a vaccine to be allowed in the country, it must pass through the rigorous process of clinical trials in the country, and as per reports, neither Pfizer nor its partners had asked to hold such trials. The DCGI however has the discretionary power to waive localised clinical trials for a vaccine”, officials said. As of today, such power has never been exercised. Also, the vaccine developed by Pfizer requires advanced storage facilities which the country lacks severely. It is also not cheap, making it difficult for the general population of the country to get a dose.