U.S. FDA For Greater Freedom To Generic Company In Product Labelling

Washington: U.S. drug regulator FDA is planning to allow generic-drug makers, including those from India, to independently update product labelling when they discover new safety data, a move which can bring them at par with branded medicine manufacturers.

Generic manufacturers, which make cheaper but therapeutically equivalent versions of innovative drugs, would be required to inform the brand name manufacturer about the labelling change.

The U.S. market is home to generic drug spending of about $300 billion every year and India produces nearly 40 percent of generic and over-the-counter products, while its share in the finished dosage medicine segment is about 10 percent.

Under the new proposal, generic drug manufacturers would be able to independently update product labelling (also called prescribing information or package inserts) with newly- acquired safety information before the FDA's review of the change, in the same way brand drug manufacturers do today.

If the proposal goes ahead, then generic drug makers need not wait to update product safety information until the corresponding brand name product has received approval to update its safety information.

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