No clinical trials required in India for global Covid-19 vaccines: Globally available Covid 19 vaccines can now be launched in India without the requirement of post approval clinical trials and testing every batch of the vaccine.
The Drugs Controller General of India in a notification has said that vaccines which have been approved for restricted use by US FDA, EMA, UK MHRA and PMDA Japan and under the WHO Emergency Use Listing (EUL) and where millions of individuals have been vaccinated, the requirement of conducting post approval clinical trials and the requirement of testing every batch of the vaccine by Central Drugs Laboratory (CDL), Kasauli can be exempted if the vaccine batch has been certified and released by National Control Laboratory of 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 and the requirement of assessment of the first 100 beneficiaries for first 7 days for safety outcomes before the vaccine rolled out for further immunisation programme and other procedures for applications will remain the same.
This nod is likely to apply first to Pfizer and Moderna vaccines. AstraZeneca’s Covishield and Russia’s Sputnik have already been approved. It is not clear whether the Chinese vaccines will come under this ambit or they will apply in India.
This is being done to augment the increased availability of imported vaccines for meeting the national requirements even though the domestic manufacturing is being lifted.