DCGI exempts foreign-made COVID vaccines from post-approval bridging trials

In light of India's massive vaccination requirements, the drug regulatory body modified guidelines for the approval of COVID-19 Vaccines in India for restricted use in emergency situations that have already been approved for restricted use by the US.F A. EMA, UK MHRA, PMDA, Japan, or are listed in WHO Emergency Use Listing (EUL).

The move came 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.

The drug regulator highlighted that although the domestic manufacturing of COVID- 19 vaccines is getting augmented, the Government of India, Directorate General of Health Services, has decided to modify partially the earlier notice dated 15.04.21, regarding the regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations.

Earlier, the Medical Dialogues Team had reported that the Central Drugs Standards Control Organisation (CDSCO) headed by the Drugs Controller General of India (DCGI) had prepared detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations. According to the above-mentioned guidelines, in order to get authorization for Restricted Use in an Emergency Situation, the applicant must commence post-approval bridging clinical trials within 30 days of such approval.

'Bridging trials', so-called because they "bridge" the gap between studies conducted in several regions, are localised clinical trials that generate data in an India-specific context, thereby assessing the efficacy of a certain vaccine in Indian participants. This is important since certain pharmaceutical products react differently to Indian genetic makeup than how they might in American or European populations.

In addition, each batch of the vaccine will be released by Central Drugs Laboratory (CDL), Kasauli, before it can be used as per the guidelines prescribed under the National Covid-19 vaccination programme and the applicant, will only use the Covid vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to CDSCO.

Now through the latest notice, CDSCO has partially modified the earlier guidelines regarding the regulatory pathway for approval of foreign approved Covid vaccines, stating,

"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 of 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."

However, it has also been mentioned that 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 immunization programme, along with other procedures for the filing of applications and timelines for processing of the applications, etc. as laid down in the notice dated15.04.21 shall remain the same.