The decision on applications for restricted emergency use authorization of foreign-made vaccines will be made within three working days from the date of filing, the government said.
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The Indian Medicines Agency will make a decision on applications for approval of restricted emergency use of foreign-made vaccines within three working days from the date of filing, the government said Thursday.
The Central Drug Authority (CDSCO) will process applications for registration of certificates (registration of manufacturing facility and product overseas; in this case, COVID vaccine) and import license within three working days from the date of authorization of restricted use in emergency situations.
The CDSCO issued detailed guidelines setting out the path of approval for overseas approved Covid-19 vaccines after the central government decided on Tuesday to speed up emergency approvals for any coronavirus jabs approved by the WHO or regulators in the USA, Europe, UK or Japan received a similar nod.
The Union’s Ministry of Health on Thursday issued regulatory pathways for overseas-made Covid-19 vaccines, according to which the CDSCO has set detailed guidelines for the approval of overseas-approved Covid-19 vaccines.
The government had on April 13th Approved streamlining and rapid follow-up of the regulatory regime for Covid-19 vaccines approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed on the WHO Emergency Use List (EUL) are.
This decision will allow India to have faster access to such foreign vaccines and encourage imports, including bulk drug imports, making the most of domestic filling and final capacity, which in turn will improve vaccine manufacturing capacity and overall vaccine availability in the country, said the Ministry.
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