India’s drug regulator on Tuesday waived the requirement to conduct post-launch bridging trials for foreign-made coronavirus vaccines, in a move that is expected to bolster the availability of shots. The Drugs Controller General of India has also done away with the mandatory testing of every batch of such vaccines at the Central Drugs Laboratory in Kasauli.
In a notice, Drug Controller General of India VG Somani said that the decisions were taken “in light of huge vaccination requirements in India”.
Under the altered regulations, post-approval bridging clinical trials can be exempted for Covid-19 vaccines with restricted use permissions from regulators of the United States, United Kingdom, European Union, Japan and the World Health Organisation.
The decisions came in the backdrop of pharmaceutical companies Pfizer and Cipla putting forth such demands during negotiations to supply imported vaccines to India, PTI reported. The notice, however, added that the existing norm of conducting a safety outcomes assessment on the first 100 beneficiaries for seven days before the vaccine is rolled out for larger public will continue to hold.
Last month, US-based Pfizer has sought fast-track approval for its vaccine from the government. It is in talks with the Centre to roll out five crore doses between July and October this year. Pfizer was the first company to seek emergency use authorisation for its vaccine in India late last year. But it withdrew its application in February after the drugs regulator asked for a local safety study for the vaccine.
Russia’s Sputnik V is the third vaccine to receive emergency-use authorisation in India after the Serum Institute’s Covishield and Bharat Biotech’s Covaxin. The Centre has repeatedly said that vaccines from more manufacturers are in the pipeline and that it expects to inoculate the country’s entire population by the end of 2020. However, several states have been hit with shortages of vaccine and only a little over 4% of the population have been fully inoculated so far.