COVID-19 Vaccine: India’s DCGI waives post-approval bridging trials for Pfizer, Moderna
The Drug Controller General of India (DCGI) waives the requirement for foreign companies to conduct post-launch bridging trials here in the country. Read all you need to know.
The Drug Controller General of India (DCGI) on June 1, 2021, waived the requirement for foreign companies to conduct post-approval bridging trials here in the country if they have the use permissions from regulators or health bodies.
A notice issued by DCGI read that the requirement for foreign companies for conducting post-approval bridging trials of COVID-19 vaccines can be exempted if they have restricted use permissions from regulators like Japan’s PMDA (Pharmaceutical and Medical Devices Agency), UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), EMA (European Medicines Agency), USFDA, or those that have emergency use authorization from WHO.
The notice by DGCI on June 1 mentioned that the decision to waive post-launch bridging trials was taken on the recommendation of the National Expert Group on Vaccine Administration (NEGVAC) for COVID-19. The decision was taken to amid the ‘huge’ vaccination requirements in India and to meet the national requirements of imported vaccines.
The notice further stated that however, the safety outcomes assessment will still stay be conducted on the first 100 beneficiaries for seven days before the rollout of a vaccine for the larger population.
Companies will also be exempted from mandatory testing of each batch of their vaccine by the Central Drugs Laboratory (CDL) in Kasauli if that batch of vaccine has certified by the National Control Laboratory of the country of origin.
However, the certificate of analysis of the batches of vaccines and review of the summary lot protocol will be carried out by CDL before releasing vaccines to the larger population.
The procedures of filing applications and time requirements for processing them will stay in place, the notice further stated.
Both, Pfizer and Cipla in May 2021 had requested the Centre to exempt them from post-approval bridging trials for their vaccines in India. Cipla has been working on bringing Moderna’s single-dose mRNA booster vaccine to India.