BDR Pharma gets FDA nod to distribute Remdesivir to Maharashtra

Mumbai: In a bid to address the shortage of Remdesivir vials, the Food and Drugs Administration (FDA) in its order has allowed the BDR Pharmaceutical International to distribute Remdesivir injections under emergency and very high demanding situation for the state government supply and trade in Maharashtra only. The state FDA’s order dated April 16 came after its counterpart in Gujarat had released similar order on April 12 amid rising demand for the Remdesivir.

FDA Commissioner Abhimanyu Kale has issued the order under the Drugs and Cosmetics Act, 1940 and rules thereunder. The order came after the Centre banned Remdesivir exports in the wake of burgeoning demand for the vials in the country.

BDR Pharmaceutical International had produced Remdesivir vials for export purpose but with FDA’s order it has been permitted to distribute strictly for Maharashtra Government supply or trade in the state only.

A senior FDA officer told Free Press Journal, “In view of FDA Commissioner’s order, the state government can now purchase Remdesivir injections from BDR Pharmaceutical International through Haffkine Bio-Pharmaceutical Corporation and distribute them to the government district general hospitals. These vials will not be distributed to the private hospitals.”

FDA Commissioner order reads, “The approval of Remdesivir Act Pharmaceutical Ingredient used to manufacture Remdesivir injection 100 mg/vial (Lyophilized) and Remdesivir injection 100 mg/vial(liquid) manufactured by BDR Life Sciences, which are planned for export purpose, is hereby allowed to be distributed under emergency and very high demanding situation of Covid-19 pandemic for Maharashtra Government supply or trade in Maharashtra state only.’’ Further, the FDA asked the company to submit the details of production and distribution.

Earlier, Gujarat FDA on April 12 had issued similar order allowing BDR Lifesciences to distribute Remdesivir vials meant for export purpose for Gujarat government supply or trade in Gujarat only.

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