Monday, July 26, 2021

DCGI relaxes provision of post approval bridging trials & batch testing of imported COVID vaccines

Drug Controller General of India, DCGI has relaxed provision of post approval bridging trials and batch testing of imported COVID vaccines in a bid to further expedite its availability in the country. The Central drug regulator has said that major relaxations are already in place to aid quick and seamless vaccine import.

It added that as per the recommendations of the National Expert Group of Vaccine Administration for Covid- 19, NEGVAC, the requirement of conducting post approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli will be exempted.

The exemption has been given to vaccines which have already been approved by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL) and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with it. However, the DCGI has informed that scrutiny and review of the Summary Lot Protocol & Certificate of analysis of the Vaccine Batch will still be undertaken by CDL Kasauli.

It added that the requirement of assessment of the vaccines on the first 100 beneficiaries for 7 days for safety outcomes along with other procedures for filing of applications and timelines will also remain unchanged as was laid down earlier in the month of April this year.

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