DCGI exempts post approval bridging trials, CDL testing for imported vaccines approved by select regulators

Drug Controller General of India (DCGI) on June 1 waived the requirement of conducting post approval briding clinical trials and testing every batch of COVID-19 vaccine by the Central Drugs Laboratory (CDL), Kasauli for foreign made vaccines.

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) and which are well established vaccine from the stand point that millions of individuals have already been vaccinated with the said vaccines.

The requirement of assessment on the first 100 beneficiaries for 7 days for safety outcomes before the vaccine is rolled out for further immunization programme along with other procedures for filing of applications and timelines for processing of the applications, etc. as laid down in the notice on April 15 will remain.

The government earlier required local clinical trials or bridging studies that involves testing the vaccine in Indian participants to assess the safety and immunogencity in the local population for vaccines developed overseas.

DCGI also said the imported vaccine batches will have to be certified and released by National Control Laboratory of Country of Origin.

CDL will review their Summary Lot Protocol and Certificate of analysis of batch or lot shall for release as per the standard procedures.

VG Somani, DCGI said the exemptions were given based on recommendation of the National Expert Group on Vaccine Administration for Covid-19 (​NEGVAC).

"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 the national requirements," Somani said.