Govt fast-tracks emergency approvals of foreign COVID jabs, cuts approval time for vaccine

New Delhi, April 15: Boosting the availability of COVID vaccines in the country, the centre is going to fast-track emergency approvals for all foreign COVID -19 jabs that have been given a similar nod by the WHO, or regulators in the United States, Europe, Britain, or Japan. With that decision, government cuts approval time for foreign Covid-19 vaccines.

 

Now, govt will process applications for registration certificates and import licenses of foreign-made Covid-19 vaccines in 3 days after being given emergency-use approval. Union Health Ministry announced the decision amid the surge in COVID-19 cases.

 

The union health ministry on Thursday said, "CDSCO (Central Drugs Standard Control Organisation) will process applications for Registration Certificate (registration of oversees manufacturing site and product: in this case Covid vaccine) and Import License, within 3 working days from the date of approval of Restricted Use in Emergency Situation."

 

 

 

The government said Covid-19 vaccines cleared for use in the US, the UK, the European Union, and Japan will get fast-track approval in India. The government had also waived the requirement for vaccines that have been cleared by the World Health Organisation (WHO).

The CDSCO headed by the Drugs Controller General of India (DCGI) will issue a detailed guideline specifying the regulatory pathway for such approvals based on recommendations from the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC),

 

 

The CDSCO will approve the protocol for the bridging trial in consultation with the Subject Expert Committee (SEC) within 7 days of the receipt of the proposal. The government will also ask the applicant to conduct the bridging trial within the timelines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO. Based on the bridging trial result DCGI will issue permission for restricted use in emergencies with the condition that the vaccine shall be used as per guidelines prescribed under the National COVID-19 Vaccination Programme.

 

 

 

This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill, and finish capacity. As per the new norms, such vaccines will have to rather undergo a parallel bridging trial upon launch in India.

 

 

The first 100 beneficiaries of such vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further vaccination. The applicant shall initiate conduct of post-approval bridging clinical trials within 30 days of such approval, the ministry further said.

On April 13, the Centre had approved the streamlining and fast-tracking of the regulatory system for COVID-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL). Yesterday, the centre has approved the transfer of Covaxin technology from Bharat Biotech to Hufkin Institute.

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