In an attempt to fast-track the import of foreign vaccines like Pfizer and Moderna, the Drug Controller General of India (DCGI) has finished the requirement of India-specific trials. The foreign vaccines approved by several countries and the WHO will not need bridging trials in India, the Drug Controller said.
Both Pfizer and Moderna had requested for waivers like indemnity and post-approval local trials from the Indian government. India has done away with the local trials but the government is yet to take decision on indemnity or liability from compensation for any serious side effects.
In its letter the DCGI has said that it has waived the requirement for foreign companies to carry out “post-launch bridging trials” and to test their stability and quality in India as they have approvals from many counties as well as the health bodies.
The DCGI chief, Dr. VG Somani has also said 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”.
“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,” he said in the letter.
Earlier, the vaccines that have completed their trails in other countries were required to carry out “bridging trials” or some clinical trials in India to know how those vaccines work on Indian population.
The Central government has decided to vaccinate whole population of India by this year end which will require massive vaccine stocks. Currently vaccination is on halt in many states due to shortage of vaccines. The government has planned to have 1 crore doses of vaccines everyday from July and foreign vaccines are going to a big part of it.
Presently only two vaccines are being used for vaccination in India that are Covidshield and Covaxin. While, Russia-based Sputnik V is the third vaccine that has been approved for use in India.