Stricter checks for generic medicines in India

To boost public confidence in generic medicines, India’s drug controller is putting stringent quality control measures in place.

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

“It is part of the data collected under the BA/BE (bioavailability and bioequivalence) study, wherein the reference product or the first brand will be given by the drug controller that is duly tested,” said Dr R Chandrashekhar, deputy Drug Controller, Central Drugs Standard Control Organization (CDSCO).

“The onus will lie on the generic manufacturer to prove that the quality of their drug is similar to the branded one,” he said during the 70th Indian Pharmaceutical Congress held in the Amity University campus.

Even though the government has been widely promoting generic medicines, these have not gained popularity because of quality concerns.