Published: 15 Apr 2021 06:20 PM BdST
Updated: 15 Apr 2021 06:20 PM BdST Workers from Afghan health ministry unload boxes containing vials of COVISHIELD, a coronavirus disease (COVID-19) vaccine donated by Indian government in Kabul, Afghanistan February 7, 2021. REUTERS/Omar Sobhani/File Photo
India said on Friday its drugs regulator will decide on emergency-use applications for foreign COVID-19 vaccines within three working days from application, as it tries to attract Pfizer, Johnson & Johnson and Moderna to sell their shots. );
}
The regulator will process such applications for Restricted Use in Emergency Situation and its chief will consider and take a decision within 03 working days from date of submission of complete application by the applicant, the health ministry said in a statement.
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.
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
Health Ministry issues regulatory pathways for foreign-produced COVID-19 vaccines ANI | Updated: Apr 15, 2021 14:35 IST
New Delhi [India], April 15 (ANI): 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.