The Indian unit of drug maker Pfizer has applied to the Drug Controller General of India (DCGI) for formal approval for emergency use of the Covid-19 vaccine developed by it. Pfizer made this request after its Covid-19 vaccine was approved in the UK and Bahrain.
Official sources said that in its application filed to the drug regulator, the company has requested approval for import and distribution of the vaccine in the country. Apart from this, under the special provisions of the Drugs and Clinical Trials Rules, 2019, the population of India is also requested to be exempted from clinical trials.
The source said that Pfizer India has applied to the DGCI on December 4 for approval for the emergency use of its Covid-19 vaccine in India. The UK on Wednesday granted temporary approval for Pfizer’s Covid-19 vaccine for emergency use.
Bahrain became the second country in the world after Britain to formally approve the emergency use of the Covid-19 vaccine developed by pharmaceutical manufacturer Pfizer and its German partner Bioentech. The pharmaceutical company has already applied for such approval in the US.