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India’s apex drug regulator has waived the requirement of testing every batch of foreign-made Covid-19 vaccines by the Central Drugs Laboratory, Kasauli, and post-launch bridging trials for such firms, a move that will bolster the availability of vaccines.
The decision by the Drugs Controller General of India (DCGI) comes from the backdrop of Pfizer and Cipla putting forth similar demands during negotiations to supply imported vaccines to India.
These exemptions have been made in light of the huge vaccination requirements in India in the wake of the recent surge of Covid-19 cases and the need for increased availability of imported vaccines to meet national requirements, according to DCGI.
“It has been decided that for approval of Covid-19 vaccines in India for restricted use in an emergency situation which is already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing and which are well-established vaccines from the standpoint that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post-approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of the country of origin,” it said.
However, scrutiny of their summary lot protocol and certificate of analysis of batch or lot shall be undertaken by CDL, Kasauli for release as per standard procedures and requirement of assessment on the first 100 beneficiaries for seven days for safety outcomes before the vaccine is rolled out for further immunization programme, the DCGI said in a notice issued on June 1.