No clinical trials necessary for global vaccines in India

New Delhi: Covid-19 vaccines which are globally available can now be administered among the Indian populace without the post-approval clinical trials of every batch of Covid-19 vaccine.

In a notification, the Drugs Controller General of India (DGCA) has said the 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.

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.

Following this, the Union government is likely to grant indemnity to Pfizer and Moderna in India, sources said, adding that it will be along the lines of the approach taken by the USA and other countries that have rolled out the aforesaid vaccines. The pending indemnity clause is causing delays in the emergency nod to the vaccines.

With the current development, the foreign-made vaccines are expected to come to India soon. Dr VK Paul, who is also a NITI Aayog member, had earlier informed that Pfizer had requested indemnity against liability from all nations, including their country of origin, the United States. "They have requested indemnity against liability to all the nations, even the US. We are examining this request. We will take decision in the larger interest of people. It is under discussion but there is no decision as of now," he had added. The decision by the Drugs Controller General of India (DCGI) comes in the backdrop of Pfizer and Cipla putting forth similar demands during negotiations to supply imported vaccines to India.