Moderna, Pfizer a step closer to boost India's COVID vaccination drive as DCGI waives post-approval bridging trials
New Delhi | Jagran News Desk: In a bid to fast-track the import of more COVID-19 vaccines in India, the Drugs Controller General of India (DCGI) on Wednesday said that the foreign COVID-19 vaccines, developed and approved by specific countries and WHO for emergency use, will not need to conduct bridging trials in India to test the quality of the jab.
The DCGI said that the requirement for foreign manufacturers to conduct the post-launch bridging trials to test the quality and stability of their vaccines in India has been waived off. However, the DCGI said that the waiver will only imply if the manufacturers have the approvals from the health bodies of the specific countries and the WHO.
The waiver by the DCGI will clear the way in India for foreign vaccines like Moderna and Pfizer, who had already requested the government to provide them waivers like indemnity and post-approval local trials during negotiations to supply imported vaccines to the country. The waiver was recommended by the National Expert Group on Vaccine Administration for COVID-19 or NEGVAC.
DCGI Chief, V G Somani, in a letter, stated that the landmark decision was taken to cater for the huge requirement of vaccines in India and the need for increased availability of the imported vaccines against COVID-19. However, the letter further stated that a safety outcomes assessment should be conducted on the first 100 beneficiaries for seven days before rolling out the vaccine.
"It has been decided that for approval of COVID-19 Vaccines in India for restricted use in an 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 standpoint 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," DCGI chief, VG Somani said in the letter.
"However, scrutiny and review of the summary lot protocol and certificate of analysis of batches of these vaccines will still be undertaken by CDL to release them for use in the country. Other procedures for the filing of applications and timelines for processing them will still have to be followed", the letter stated.
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.
Posted By: Talibuddin Khan