COVID-19 Vaccine India: India’s drug regulator will decide on the application to approve the banned emergency use of the vaccine produced abroad, within three working days of the date of submission. The government gave this information on Thursday. The Central Drug Authority will process applications for the CDSCO registration certificate and import the license within three working days from the date of approval of restricted use in the event of an emergency.
CDSCO released guidelines
CDSCO has released detailed guidelines showing the regulatory route for the approval of the approved COVID-19 vaccine abroad. The central government had earlier on Tuesday decided to expedite emergency approval for all Corona virus vaccines, which have received similar approval from WHO or regulators in the US, Europe, UK or Japan.
The Union Health Ministry on Thursday released regulatory avenues for COVID-19 vaccine produced abroad, according to which CDSCO has prepared detailed guidelines for regulatory approval for the approval of COVID-19 vaccine approved abroad. On April 13, the government approved streamlining and fast tracking of regulatory systems for COVID-19 vaccines that have been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA, Japan, or the Emergency Use Listing (EUL) Is listed in
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The Ministry said that this decision will give early access to such foreign vaccine by India and will encourage import which includes import of bulk drug material. With this, the entire consumption and capacity of domestic fill will also be encouraged. According to the ministry, this will also encourage the manufacture of vaccines within the country and the availability of total vaccines.