The Drugs Controller General of India (DCGI), Dr VG Soman on Wednesday announced that vaccines against the coronavirus disease (Covid-19) approved by specific countries and the World Health Organisation (WHO) no longer require post-approval bridging trials and batch testing in India. If the vaccine has been certified and released by the national control laboratory of certain countries or if it is listed in the WHO Emergency Use Listing (EUL), it can be exempted from the aforementioned requirement, stated a letter issued by the Central Drugs Standard Control Organisation (CDSCO).
‘Bridging trials’, so called because they “bridge” the gap between studies conducted in several regions, are localised clinical trials that generate data in an India-specific context, thereby assessing the efficacy of a certain vaccine in Indian participants. This is important since certain pharmaceutical products react differently to Indian genetic makeup than how they might in American or European populations.
The decision, it was said, had been taken because of the “huge vaccination requirements in India in the wake of the recent surge in Covid-19 cases”. The drug regulatory body noted that although the “domestic manufacturing of Covid-19 vaccines is getting augmented”, the earlier order was being partially modified “to meet the national requirements”.
