On Tuesday, India’s apex drug regulator expressed the requirement to conduct post-launch bridging trials and test the quality and stability of their Covid-19 vaccines in India if they have approvals from particular countries or health bodies. This was waived specifically to the foreign companies.
As mentioned, there is an exemption to the companies for their “every batch” of vaccine to be tested by the Central Drugs Laboratory (CDL) in Kasauli, only if “the vaccine batch/lot has been certified and released by the National Control Laboratory of the country of origin.” The said scrutiny and review of the summary lot protocol and certificate of analysis of batches of these vaccines will still be undertaken by CDL to release them for use in the country, according to the notice.
As per PTI report dated May 25, 2021, Pfizer requested the centre to exempt them from the requirement of post-approval bridging trial for its vaccine which is developed together with BioNTech.
Another request for an exemption from bridging trials, has been put up by Cipla who wishes to commit $1 billion in order to bring Moderna’s single-dose mRNA booster vaccine to India. As per a PTI report on 31st May 2021.
On 15th April, an early notice that allowed foreign companies with approvals from the same regulatory authorities as mentioned in Tuesday’s order to skip the requirement for local clinical trials in their request for Emergency Use Authorization was modified by the exemptions of the latest DCGI.