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 vaccine) and import license within three working days from the date of approval of restricted use in an 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.
Union Health Ministry Issues Regulatory Pathways for foreign-produced COVID-19 Vaccines
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Drug controller to speed up applications of foreign-made vaccines | India News
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Aditi Tandon
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).”