Proven vaccines no more need clinical trials in India

India’s drug regulator on Tuesday decided to waive off bridging clinical trials for well-established vaccines and did away with the requirement for testing every batch of shots to enable an easy supply of imported jabs in India.

The development comes against the backdrop of negotiations between the government and Pfizer over the import of its Covid-19 vaccine in India, which is likely to begin from July.

The decision has been taken following a recommendation by the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), the drug regulator said in a notice Tuesday.


According to a notice issued by the Drug Controller General of India (DCGI), vaccines that have been approved for restricted use by regulatory bodies in the US, EU, UK and Japan or by the WHO and which are well-established will be exempted from the requirement of conducting post-approval bridging clinical trials as well as the requirement of testing of every batch of vaccines by the Central Drugs Laboratory (CDL), Kasauli.

The batch will have to be certified by the national control laboratory of the country of origin.

CDL, Kasauli, will be required to review the safety outcomes in the first 100 beneficiaries for seven days before the vaccine is rolled out as part of the immunisation drive.

On April 13, in a statement on fast-tracking emergency approvals for foreign vaccines, the government had said permissions would be granted, “mandating the requirement of post-approval parallel bridging clinical trials in place of conduct of local clinical trials.”

“Further, the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country,” it had said.

Considering the extraordinary situation and the need to develop vaccines in a short timespan amid the pandemic, a decision has been taken to increase the basket of vaccines in India, a senior government official said.

Pfizer, AstraZeneca, Johnson & Johnson, Moderna and Sinopharm vaccines have so far been approved by the WHO for emergency use.