Foreign produced COVID-19 vaccines: Decision on emergency use applications to be taken in 3 days

India will decide on the emergency use authorisation of foreign vaccines within three working days of receiving an application, according to the guidelines issued by the health ministry on Thursday.

The regulatory pathway offers a liberalised approval process to be followed by the Central Drugs Standards Control Organisation (CDSCO) under the Drugs Controller General of India (DCGI). CDSCO will accept applications for Covid-19 vaccines approved for restricted use by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (UK MHRA), Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and those on the emergency use list of the World Health Organisation.

The government had on Tuesday decided to allow Covid-19 vaccines developed and granted emergency use approval in other countries for use in India without clinical or bridging trials to increase availability as it battles a deadly second wave amid a shortage of supplies.

Application via Indian Arm or Authorised Agent
The vaccine application can be made by a foreign manufacturer through its Indian subsidiary or authorised agent if it doesn’t have one.


"CDSCO will process such applications for Restricted Use in Emergency Situation and DCGI will consider and take a decision within three working days from date of submission of complete application by the applicant," the health ministry said in a statement. The company has to initiate bridging trials within 30 days of approval.

The agency will process applications for registration certificates and import licences within three working days from the date of approval for restricted use. Every vaccine batch will be released by the Central Drugs Laboratory (CDL), Kasauli. The first batch will be used to inoculate 100 beneficiaries, who will be assessed for a week and their outcome data analysed by CDSCO. Once cleared, CDSCO will authorise use of the vaccine in the immunisation programme.

CDSCO will approve the bridging trial protocol in consultation with the Subject Expert Committee (SEC) within seven days of the receipt of the proposal. Applicants will conduct bridging trial within the timelines specified in the protocol and submit the data generated to CDSCO. After getting the bridging trial results, the DCGI will review the permission granted for restricted use. The bridging trial will be distinct from the week-long check with the 100 beneficiaries.