Swiss Regulator Writes Up Indian Firm for Multiple Violations

Switzerland’s drug agency Swissmedic rapped an Indian drugmaker for significant CGMP violations at a facility near Mumbai.

The Swiss investigators discovered five serious violations and numerous others at the Acharya Chemicals facility — including failing to control the risk of cross-contamination and not properly preparing before introducing a new chemical entity into the synthesis area.

Acharya failed to qualify or properly monitor its raw material storage area, posing a risk for the starting material metronidazole, Swissmedic said, in a report to the EU’s EudraGMDP inspection database.