APPROVAL FOR FOREIGN VACCINES IN 3 DAYS AFTER SUBMISSION: GOVT
The CDA will process applications for registration certificates
NEW DELHI: India’s drug regulator will take a decision on applications seeking approval for restricted emergency use of foreign produced vaccines within three working days from the date of submission, the government said on Thursday.
The Central Drug Authority, CDSCO, will process applications for registration certificates and import license within three working days from the date of approval of restricted use in emergency situation. An application can be made by a foreign manufacturer through its Indian subsidiary. It can also be filed through an authorised agent in India in case a company does not have an Indian subsidiary.
The CDSCO issued detailed guidelines specifying regulatory pathway for approval of foreign approved Covid-19 vaccines after the Centre on Tuesday decided to fast-track emergency approvals for all coronavirus jabs that have been given a nod by major regulators across the world.
NEW DELHI: India’s drug regulator will take a decision on applications seeking approval for restricted emergency use of foreign produced vaccines within three working days from the date of submission, the government said on Thursday.
The Central Drug Authority, CDSCO, will process applications for registration certificates (registration of overseas 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 in emergency situation.
The CDSCO issued detailed guidelines specifying regulatory pathway for approval of foreign approved COVID-19 vaccines after the central government on Tuesday decided to fast-track emergency approvals for all coronavirus jabs that have been given a similar nod by the WHO or regulators in the United States, Europe, Britain or Japan. The Union health ministry on Thursday issued regulatory pathways for foreign produced COVID vaccines according to which the CDSCO has prepared detailed guidelines specifying regulatory pathway for approval of foreign approved vaccines.