Union Health Ministry Issues Regulatory Pathways for foreign-produced COVID-19 Vaccines india.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from india.com Daily Mail and Mail on Sunday newspapers.
Amid record spike in daily coronavirus infections, India s drug regulator will take a decision on applications seeking approval for restricted emergency use of foreign produced vaccineswithin three working days from the date of submission, the government said on Thursday. The CentralDrug 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 emergency situation. The CDSCO issued detailed guidelines specifying regulatory pathway for approval of foreign approved COVID-19 vaccines after thecentral 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.
Drug controller to speed up applications of foreign-made vaccines | India News indiatimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from indiatimes.com Daily Mail and Mail on Sunday newspapers.
Health Ministry issues regulatory steps to approve foreign made COVID-19 vaccines
Health Ministry issues regulatory steps to approve foreign made COVID-19 vaccines
15 April 2021 | News DCGI will consider and take a decision within three working days from the date of submission of the complete application
Image credit- shutterstock.com
The Union Health Ministry has issued the Regulatory Pathway in India 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).
CDSCO shall prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) recommendations.
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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).”