The rule applies to vaccines approved for restricted use by the FDA, EMA, MHRA and PMDA, and under WHO’s Emergency Use Listing.

COVID-19 vaccine being drawn out of the vial using a syringeImage for representation
Coronavirus Covid-19 Vaccine Wednesday, June 02, 2021 - 15:51

Globally available COVID-19 vaccines can now be launched in India without the requirement of bridging trials and testing every batch of the vaccine, the Drug Controller General of India (DGCI) has announced. In a notification,the DGCI has said that post-approved clinical trials and testing of every batch by the Central Drugs Laboratory (CDL) can be exempt if they are approved for restricted use by US FDA, EMA, UK’s MHRA and PMDA Japan, and under the WHO Emergency Use Listing (EUL) and where millions of individuals have been vaccinated, if the vaccine batch has been certified and released by National Control Laboratory of the country of origin. 

However, scrutiny and review of their summary lot protocol and certificate of analysis of the batch shall be undertaken by CDL, Kasauli for batch release, as per standard procedures. The requirement of assessment of the first 100 beneficiaries of the vaccines for the first seven days for safety outcomes, before the vaccine is rolled out for further immunisation programmes, and other procedures for applications will remain the same. However, it is not clear whether this rule will apply to the China-made Sinovac- Coronavac vaccine, which was approved for emergency use by WHO on Wednesday, June 2.

This nod is likely to apply first to Pfizer and Moderna vaccines. AstraZeneca's Covishield and Russia's Sputnik have already been approved for restricted emergency use in India. The DGCI’s announcement to launch globally available COVID-19 vaccines without the requirement of bridging trials and testing of every batch, comes when states have been floating global tenders to vaccine manufacturers. On Tuesday, June 1, a consignment of 56.6 tonnes of Russian-made Sputnik V vaccines reached the GMR Hyderabad Air Cargo from Russia, making it the largest import shipment of COVID-19 vaccines to be handled in India so far.

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