New Delhi, April 15
Amid a COVID spike and daily cases setting a new grim peak on Thursday, the Indian drug regulator said that it would process the applications from the makers of the already approved COVID vaccine.
The process would take place within three working days of submission of fast track job procurement and fast track process.
Detailing the regulatory pathway that would enable foreign-made vaccines to enter the Indian markets, the Central Drug Standards Control Organisation (CDSCO) said: “The CDSCO would process applications for Restricted Use in Emergency Situation and the Drug Controller General of India would consider, and make a decision within three working days from the date of submission of a complete application by the applicant. The application can be made by the foreign manufacturer through its Indian subsidiary or through its authorized agent in India (in case it does not have an Indian subsidiary).”
The pathway was published after the government agreed to waive off domestic clinical trial requirements before the grant of emergency use approval to vaccines made abroad and got cleared by credible regulators like, the USFDA, the European Medicines Agency, the UK and Japan regulators and the vaccines included in the WHO emergency use list.
The WHO list has three Chinese made jabs, including Sinovac.
The government has mandated, that the foreign applicants start bridging studies after the approval for restricted emergency use of their vaccines in India, and use the jab first on 100 people whose safety profile would be reviewed before the final rollout of the jab in the national COVID inoculation drive.
The CDSCO has prepared detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations and disseminated them widely.
Under the guidelines, the applications for grant of approval for Restricted Use in the Emergency may be submitted to CDSCO.
DCGI will issue permission for Restricted Use in the Emergency with the following conditions — Vaccine shall be used as per the guidelines prescribed under National Covid-19 Vaccination Programme; the first 100 beneficiaries of such vaccines shall be assessed for 7 days for safety outcomes before it is rolled out for further Vaccination programme; the applicant shall initiate conduct of post-approval bridging clinical trials within 30 days of such approval; applications for Restricted Use in the Emergency for such vaccines may be accompanied by bridging trial protocol, application for an import registration certificate and application for an import license.
The CDSCO said that it would process applications for Registration Certificate (registration of overseas manufacturing site and product for Covid vaccine) and Import License, within three working days from the date of approval of Restricted Use in Emergency Situation.
“As per the existing protocol of CDSCO for batch release of vaccines, 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.
The applicant will use the Covid vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to CDSCO after which the CDSCO will review the safety data submitted by the applicant, and once found satisfactory, will authorise the applicant to use the vaccine.
The CDSCO will approve the protocol for the bridging trial in consultation with the Subject Expert Committee (SEC) within seven days of the receipt of the proposal,” the guidelines said.
The regulator also said the applicant will conduct the bridging trial within the timelines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO.
After the receipt of the bridging trial results, the DCGI will review the permission granted for Restricted Use in an Emergency.