In view of the second wave of covid and the threat of rising cases, the government is only focusing on increasing the vaccination boom. In such a situation, more and more vaccine companies need to be in India. Therefore, DCGI has taken a major decision to increase the pace of vaccination.

No separate local trials: It has been revealed that the Indian pharmaceutical regulator, the DCGI, has now completely removed all conditions for separate trials to bring Pfizer and Moderna company to India at the earliest. In simple terms, vaccines that have been approved for emergency use by the US FDA and the World Health Organization will not have to undergo a separate trial process in India.  Not only that, till now, any foreign company had to conduct a bridging trial before introducing an anti-covid virus vaccine in India. It tested the effectiveness and safety of vaccines on a limited number of local volunteers, which has now exempted companies.

Notice issued by drug regulator: It is also being said that DCGI Chairman VG Somani has issued a notice informing about the same. It has also been learnt that Pfizer and Moderna are foreign vaccine companies which have appealed to the government for compensation and exemption for separate trials in India. Though the Government of India has not given any decision on compensation, it has accepted that there is no separate trial.

DCGI chief VG Somani issued notice over Guidance for approval COVID19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA & other countries or which are listed in WHO Emergency Use Listing (EUL) pic.twitter.com/aGOOSdK9jU

? ANI (@ANI) June 2, 2021

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