Drug Controller General of India DCGI, cleared path for foreign vaccines like Pfizer, Moderna, Cipla after relaxing the Indian specific clinical trial requirements, to cushion the Indian vaccination drive. Foreign COVID-19 vaccines with approval from specific countries regulators like the USFDA, EMA (European Medicines Agency), the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), Japan’s PMDA (Pharmaceutical and Medical Devices Agency) or those with a WHO Emergency Use Listing, can be exempted from post-approval bridging clinical trials.
In the notice released by DCGI chief Dr VG Somani on 1st June, stated, “in the 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.”
It further added, “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 US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL) and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of Country of Origin.”
Pzifer and Moderna are two top vaccine manufacturers, that demanded waiver from government like indemnity and for post-approval local trials, amongst some other vaccine manufacturers. However, a condition for approval of the vaccine to be rolled out for larger immunisation is, that for 7 days safety assessment outcomes to be conducted on first 100 beneficiaries.
The following decisions were taken after recommendations of NEGVAC (the National Expert Group on Vaccine Administration for Covid-19).
The notice even states that the decisions were taken in light of “huge” vaccination requirements in India and “the need for increased availability of imported vaccines to meet the national requirements”, added.