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Govt issues regulatory pathway for Covid-19 foreign vaccines approved for restricted use

Regulatory pathway for foreign vaccines issued April 15, 2021 CDSCO will widely disseminate these guidelines to the concerned stakeholders The government, on Thursday, issued regulatory pathway related to 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). The Central Drugs Standards Control Organisation (CDSCO), headed by Drugs Controller General of India or DCGI, has laid out the pathway according to which the former will prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders. Applicants for grant of approval for restricted use in emergency situation may be submitted to CDSCO. Application can be made by the foreign manufacturer through its Indian subsidiary or through its authorised agent in India in case it does not hav

Foreign produced Covid-19 vaccines: Decision on emergency use applications to be taken in 3 days | India News

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.

Indian regulator to decide on foreign vaccine makers applications in 3 days : The Tribune India

1144 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).”

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