The Centre is likely to grant indemnity to foreign drugmakers like Pfizer and Moderna, along the lines of the approach adopted by the US and other countries that have rolled out their COVID-19 vaccines.
Like other nations, the Indian government is also expected to grant indemnity to these companies if they seek drug regulator’s nod for the Emergency Use Authorisation (EUA).
“It is expected to grant indemnity against legal proceedings along the lines of what has been granted in other countries for Pfizer and Moderna vaccine companies,” ANI quoted government sources as saying.
According indemnity is like granting a concessional request of legal defence from any claims associated with the use of the foreign companies’ COVID-19 vaccines in India. The Centre has thus far not provided indemnity to any COVID vaccine maker.
Meanwhile, in another development that would bolster the availability of vaccines, the Drug Controller General of India (DCGI) has waived the requirement of testing every batch of foreign-made COVID-19 vaccines by the Central Drugs Laboratory, Kasauli and post-launch bridging trials for such firms.
The decision, taken by India’s apex drug regulator, comes in the backdrop of Pfizer and Cipla putting forth similar demands during negotiations to supply imported vaccines to India.
These exemptions have been made in 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 to meet national requirements, according to DCGI.
“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 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 of testing every batch of vaccine by 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 issued on June 1.
“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 added.
Earlier, vaccines that had concluded clinical trials outside the country were required by manufacturers to conduct bridging tests on the Indian population.
