In a big move, India’s apex drug regulator DCGI (Drug Controller General of India) has announced the waiving off the requirement of conducting post-approval bridging trials in India.
‘Bridging trials’ are supplementary trials performed in a new region or country to get more clinical data on efficacy, safety, and dose regimen.
This was done to clear the way for foreign vaccines like Pfizer and Moderna from the requirement of India-specific trials.
The decision was taken in an attempt to fast-track the import of doses needed to bolster vaccinations.
However, the government has yet to take a decision on indemnity or liability from compensation for any severe side effects.
A DCGI letter says it has waived the requirement for foreign companies to carry out “post-launch bridging trials” and to 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, stated in the 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 (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,” the letter further stated.
Earlier, the Central government has pledged to vaccinate all of India by December. But, vaccinations have slowed down or are on pause in many states because of a shortage of doses. The government hopes to have one crore doses per day by July. Foreign vaccines are expected to play a big part in it.
— ANI (@ANI) May 28, 2021
Currently, Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin are being used in the vaccination drive that started in January. Russia’s Sputnik V is the third vaccine to be approved for use in India.