Foreign Covid vaccines approved by specific countries and WHO for emergency use will not need bridging trials in India, the Drug Controller General of India (DCGI) has said in an attempt to fast-track the import of doses needed to bolster vaccinations.
This will clear the way for the entry of vaccines like Pfizer and Moderna, who had requested the government for waivers like indemnity and for post-approval local trials.
The DCGI says it has waived the requirement for foreign companies to carry out post-launch bridging trials and test the quality and stability of their vaccines in India if they have approvals from specific countries or health bodies.
The DCGI chief, VG Somani, has said in a letter that the decision was taken “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”.
This was recommended by the National Expert Group on Vaccine Administration for COVID-19 or NEGVAC.
“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,” Dr Somani said in the letter.
Earlier, vaccines that had completed clinical studies outside the country were required to carry out “bridging trials” or limited clinical trials on the Indian population to know how the drug works on people of Indian origin, in the local context.