India gets tough on generics quality issues and cancer drug prices

Even as more blood pressure drugs are being recalled in the USA after being found to contain trace amounts of a potentially cancer-causing ingredient, India’s drug controller is putting stringent quality control measures in place aiming to boost public confidence in generic medicines, reports The Pharma Letter’s India correspondent.

As part of the move, generic drug manufacturers in India will now have to prove quality and safety equivalence with a reference product that has already been tested by the regulator.

A health ministry official explained: "It is part of the data collected under the bioavailability and bioequivalence study, wherein the reference product or the first brand will be given by the drug controller to be duly tested."