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Three required things — new drug permission from the drug controller under the New Drugs and Clinical Trials Rules 2019; import licence and registration licence
Updated At: May 06, 2021 06:54 AM (IST)
Vials of the Pfizer-BioNTech vaccine are pictured in a vaccination centre. Reuters photo
Tribune News Service
New Delhi, May 5
The Drug Controller General of India on Wednesday issued guidelines for state governments and private corporate and other entities to import Covid vaccines not authorised or licensed in India but authorised by the regulators of the US, UK, EU and for vaccines on WHO emergency use list.
The guidelines would enable industry bodies, private entities and states to directly import Pfizer, Moderna, Johnson and Johnson among other foreign approved vaccines directly after getting the necessary clearances.
Anyone wanting to import such licences would need to get three things—new drug permission from the drug controller under the New Drugs and Clinical Trials Rules 2019; import licence and registration licence.
No such permission is needed to import Sputnik V which has been approved by the Indian regulator for emergency use apart from Covaxin and Covishield.
Under the new vaccine policy applicable from May 1, states and private entities can negotiate and procure foreign approved vaccines.
New guidelines facilitate the imports and say, “After obtaining the import licence, the importer or the authorized agent of the vaccine maker can import the vaccine and procure it.”
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Remembering Sardar Dyal Singh Majithia
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