After its parent company received such clearance in the UK and Bahrain, Pfizer India became the first pharmaceutical company to apply to the Drugs Controller General of India (DCGI) for an emergency use permit for its COVID-19 vaccine in the world. The company has requested approval for the import and distribution of vaccines in India in its application to DCGI.
This is the first such request received by the DCGI in the center of the race to find a deadly virus vaccine that in India has infected over 96 lakh people. In its application submitted , 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," sources have been quoted as saying by news agency PTI.
Experts also raised questions about the logistical difficulties associated with the delivery of the vaccine, which should be kept at a temperature of minus 70 degrees Celsius. It is possible to store most vaccines in India at temperatures between 2 and 8 degrees.
Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial.