Centre issues guidelines for approval of foreign-produced COVID-19 vaccines

The Central Drugs Standards Control Organization (CDSCO) on 15 April has prepared detailed guidelines specifying regulatory pathway for approval of foreign-approved COVID-19 vaccines based on NEGVAC recommendations.

By Newsmeter Network  Published on  15 April 2021 10:20 AM GMT
Centre issues guidelines for approval of foreign-produced COVID-19 vaccines

New Delhi: The Central Drugs Standards Control Organization (CDSCO) on 15 April has prepared detailed guidelines specifying regulatory pathway for approval of foreign-approved COVID-19 vaccines based on NEGVAC recommendations.

The CDSCO has posted the guidelines on its website and said it will take steps to widely disseminate these guidelines to the concerned stakeholders. Applications for grant of approval for restricted use in an emergency situation may be submitted to CDSCO.

An 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. CDSCO will process such applications for restricted use in an emergency situation and the Drugs Controller General of India (DCGI) will consider and take a decision within three working days from the date of submission of the complete application.

DCGI will issue permission for restricted use but with three conditions - vaccine shall be used as per the guidelines prescribed under National COVID-19 vaccination programme, first 100 beneficiaries of such vaccines shall be assessed for seven days for safety outcomes before it is rolled out, and applicants shall initiate conduct of post approval bridging clinical trials within 30 days of such approval.

Applications for restricted use in emergency situation for such vaccines may be accompanied by bridging trial protocol, application for import registration certificate, and application for import license.

CDSCO said it will process applications for registration certificate (registration of oversees manufacturing site and product: in this case COVID-19 vaccine) and import license within three working days from the date of approval of restricted use.

Existing protocol for vaccine use

As per the existing CDSO protocol for batch release of vaccines, each batch of the vaccine will be released by the Central Drugs Laboratory (CDL), Kasauli, before it can be used as per the guidelines prescribed under the national vaccination programme. The applicant will use the vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to CDSCO.

CDSCO will review the safety data submitted by the applicant, and once found satisfactory, will authorize the applicant to use the vaccine. The organization 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 applicant will conduct the bridging trial within the time 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 emergency situation.

On Tuesday, the Union government had recommended that foreign-made vaccines that had been granted emergency approval for restricted use by global regulators like the WHO be granted emergency approval in India. The move was intended to facilitate quicker access to foreign vaccines and encourage imports which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country.

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