2 Requirements Done Away With for COVID Vaccine Approval in India

The two requirements include conducting post-approval bridging trials & testing of every batch by CDL, Kasauli.

Delhi Chief Minister Arvind Kejriwal on Monday, 24 May, claimed that vaccine makers Pfizer and Moderna had both refused to sell the COVID-19 jabs directly to the Delhi government.

(Photo: iStock)

The Drugs Controller General of India (DCGI) has done away with two requirements for the approval and availability of certain COVID-19 vaccines in the country, which is facing an acute shortage of doses amid the devastating second wave of the pandemic.

The two requirements that have been waived include conducting post-approval bridging trials and testing of every batch of the vaccine by Central Drugs Laboratory, Kasauli, DCGI VG Somani said in a notice dated Tuesday, 1 June.

What Did the Notice Say?

"In light of the huge vaccination requirements in India in the wake of the recent surge of COVID-19 and the need for increased availability of imported vaccines to meet the national requirements even though the domestic manufacturing of COVID-19 vaccines is getting augmented... 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 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 [sic]," the notice read.

"However, scrutiny and review of their Summary Lot Protocol & Certificate of analysis of Batch/Lot shall be undertaken by CDL Kasauli for Batch release as per the standard procedures and the requirement of assessment on the first 100 beneficiaries for 7 days for safety outcomes before the vaccine is rolled out for further immunisation programme. along with other procedures for filing of applications and timelines for processing of the applications, etc... shall remain the same," it added.

The Indemnity Question

The DCGI's notice comes when India is looking to get the vaccines by Pfizer and Moderna, along with others, for use in its inoculation drive, which has failed to pick up momentum so far. Currently, three vaccines have been approved in the country – Serum Institute of India's Covishield, Bharat Biotech's Covaxin, and Russia's Sputnik V vaccine.

More than 21.85 crore vaccine doses have been administered since India’s inoculation drive began in January

Firms like Pfizer and Moderna have also asked for exemptions pertaining to indemnity, but no official decision has been taken in that regard.

However, government sources cited by news agency ANI said companies like Pfizer and Moderna can be expected to be granted indemnity against legal proceedings along the lines of what has been granted in other countries.