'No issue in granting Indemnity to Pfizer and Moderna: Govt

New Delhi, June 02: The Central government has said that there is no issue in granting Indemnity to Pfizer and Moderna in India.

"If these companies have applied for Emergency Use Authorisation in India, then we are ready to give them indemnity," ANI reported quoting sources.

The exemption will, however, be limited to COVID-19 vaccines approved in India for restricted use in emergency situation which are already approved for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or listed in WHO Emergency Use Listing (EUL).

Pfizer, which has immunity in countries like the US had in talks with the government stressed on indemnity, sharing efficacy trials and approvals for its vaccine in various countries and by WHO.

Notably, India has so far not given any manufacturer indemnity against the costs of compensation for any severe side effects.

In another key waiver, India's apex drug regulator has waived the requirement of testing every batch of foreign-made COVID-19 vaccines.

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," it said.

However, scrutiny of their summary lot protocol and certificate of analysis of batch or lot shall be undertaken by CDL, Kasauli for release as per standard procedures and requirement of assessment on the first 100 beneficiaries for seven days for safety outcomes before the vaccine is rolled out for further immunization programme, the DCGI said in a notice issued on June 1.