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The regulatory mechanism has been modified to save time in special situations like this pandemic Representational photo
Foreign-made vaccines will be able to able to bypass India’s infamous bureaucratic red tape and obtain import license and registration clearances in just three working days after being given emergency-use approval, said the Union health ministry on Thursday (April 15).
To accelerate the availability of vaccines in India witnessing a severe second surge in the pandemic, the government is pushing to fast-track the use of Covid-19 vaccines that are cleared by regulatory authorities in the US, the UK, the European Union, and Japan. A statement issued by the health ministry and reported by
The development comes after DCGI (Drugs Controller General of India) gave its nod to foreign-made and approved COVID-19 vaccines following a massive spike in coronavirus cases
Just 3 days! India cuts approval time for foreign Covid-19 vaccines
India will provide approvals to COVID-19 vaccines approved by health regulators like US FDA within 3 days; detailled guidelines to come soon
Joe C Mathew | April 15, 2021 | Updated 15:05 IST
India will take only three working days to clear the applications to import and supply 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 country s drug regulator Central Drugs Standards Control Organization (CDSCO) headed by the Drugs Controller General of India (DCGI) will issue a detailed guideline specifying the regulatory pathway for such approvals on the basis of recommendations from the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), headed by Niti Aayog member (health) Dr VK Paul soon.
NEW DELHI: The Central government on Thursday 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), said the Union health ministry. The Central Drugs Standards Control Organisation (CDSCO) headed by Drugs Controller General of India (DCGI) has explained that it prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations. These guidelines have since been prepared and posted by CDSCO on its website. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders, the ministry said.