The Drugs Controller General of India (DCGI) has exempted the need for specific trials of Covid-19 vaccines if they are approved by other international regulatory bodies or the National Control Laboratory of the Country of Origin.
This means foreign made vaccines of Pfizer and Moderna are likely to be a step closer to entering the Indian markets.
DCGI Chief VG Somani said that this would be applicable for vaccines approved for restricted use by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA) Japan or listed for Emergency Use by the World Health Organisation as per a report in Times of India.
"In light of the huge vaccination requirements and the need for increased availability of imported vaccines,... it has been decided that for approval of COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for restricted use by [international regulatories] or which are listed in WHO Emergency Use listing," Somani said in his letter.
"The scrutiny and review of their Summary Lot Protocol and Certificate of the analysis of Batch/Lot Shall be undertaken by Central Drugs Laboratory (CDL) Kasauli for batch release as per standard procedures and the requirement of assessment of the first 100 beneficiaries for 7 days for [safety outcomes] as laid down in the notice dated 15.04.21 shall remain the same." Dr Somani added.
Before this decision, foreign vaccines manufacturers needed to carry out "bridging trials" or limited clinical trials on the Indian population to know how the drug's working and its side effects.