DCGI extends shelf life of Covishield from 6 to 9 months
India’s drug regulator DCGI has prolonged the shelf life of Covishield, the Oxford-AstraZeneca COVID-19 vaccine, from six to 9 months from its manufacturing date.
In a letter to the Serum Institute of India, Drugs Controller General of India V G Somani stated the SII is permitted to apply the shelf life of 9 months to unlabelled vials obtainable readily available. Shelf life is the size of time for which an merchandise stays match to be used.
The DCGI stated it has no objection in respect of ‘Extension of Shelf Life of Covishield Vaccine’ in multi-dose glass vial (10 dose-5ml) from six months to 9 months.
“You are permitted to apply the shelf life of nine months to unlabelled vials available on hand, subject to the condition that the details of such stock, batch-wise, shall be submitted to this office and Central Drugs Laboratory, Kasauli,” Somani stated within the letter.
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