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India's drug regulator clears the way for import of Covid-19 vaccines into India

India’s drug regulator clears the way for import of Covid-19 vaccines into India
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With import licence, vaccine can be imported for supply to state governments and private entities, the regulator has said in a set of guidance released for import of vaccines by private sector and state governments.
According to the drug regulator any private entity can procure the vaccine from the importer for its use if the vaccine to be imported is approved by the drug regulatory authority and import license has been obtained from it.
If the vaccine is not yet approved or licensed, the importer or the authorised agent of the manufacture of the vaccine will have to obtain permission license from the regulatory authority which includes the New Drug Permission under New Drugs & clinical Trials Rules, 2019, import registration under Drugs Rules, 1945 and Import licence under Drugs Rules, 1945. ....

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Zimbabwe's delicate trade/industry balance – The Zimbabwe Mail

Zimbabwe's delicate trade/industry balance – The Zimbabwe Mail
thezimbabwemail.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thezimbabwemail.com Daily Mail and Mail on Sunday newspapers.

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J&J Seeks Permission for Phase-3 Trial of Its Single-Shot Covid Vaccine in India, Import Licence

J&J Seeks Permission for Phase-3 Trial of Its Single-Shot Covid Vaccine in India, Import Licence
News18
2 hours ago
News18
Multinational pharma giant Johnson & Johnson has applied to India’s drug regulator seeking permission to conduct phase-3 clinical trial of its single-dose Covid-19 vaccine in India as well as import licence, sources said.
© Provided by News18
J&J Seeks Permission for Phase-3 Trial of Its Single-Shot Covid Vaccine in India, Import Licence
They said the company has sought an early meeting of the subject expert committee on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) to take a decision on its application. ....

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Just 3 days! India cuts approval time for foreign Covid-19 vaccines

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. ....

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Govt issues regulatory pathway for Covid-19 foreign vaccines approved for restricted use

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 ....

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