Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine in the country, after its parent company secured permission in the UK and Bahrain.
Official sources said, the firm, in its application submitted to the drug regulator, has sought after permission to import the vaccine for sale and supply in the country, besides waiver of clinical trials on Indian population accordance with the special provisions under the New Drug and Clinical Trials Rules, 2019.
“Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its COVID-19 vaccine in India,” a source said.
The UK became the first country to grant permission to Pfizer/BioNTech. The pharma company has already applied to the US FDA seeking EUA for the vaccine.
“The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s COVID-19 mRNA vaccine BNT162b2 in the country,” the source said, citing the application.
The extreme low temperature of minus 70 degrees Celsius required for storing the vaccine presents as a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, top government officials have said.
When contacted, Pfizer said it remains loyal to engaging with the Government of India and exploring opportunities to make this vaccine available for use in the country.
Five vaccines are in advanced phase of clinical trials in India with the Serum Institute of India performing phase-3 trial of the of the Oxford-Astrazeneca COVID-19 vaccine, which the indigenously developed vaccine by Bharat Biotech in association with ICMR has already started the phase-3 clinical trial.
“During this pandemic phase, Pfizer will supply this vaccine only through Government contracts based on agreements with respective government authorities and following regulatory authorisation or approval,” the global pharma major said in statement.
Drug firm Zydus Cadila has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed anti coronavirus vaccine.
Dr. Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) have announced that they commenced adaptive phase 2 and 3 clinical trials for COVID-19 vaccine Sputnik V in India, Also, Biological E. Ltd has started early phase 1 and 2 human trials of its COVID-19 vaccine candidate