Counterfeit drugs: Cofepris Detects Batches of Adulterated Trastuzumab While Legislature Advances in Regulations
31 julio 2019

MEXICO

Following a complaint filed by Roche Laboratories, the Federal Commission for Protection against Sanitary Risks (Cofepris) on July 23 published the results of an investigation into the falsification of the product HERCEPTIN (Trastuzumab). The Commission identified the batches of the counterfeit product and informed the actions it would take to strengthen surveillance and control delivery and courier services. At the same time, the deputies’ Justice Committee passed an initiative to prohibit the sale of apocryphal medicines and step up penalties for public officers found stealing medicines.  It is likely that this initiative will be discussed at the plenary session in early September, when Congress resumes its activities.

After concluding its investigation into the products, Cofepris revealed that it had detected five counterfeit batches: N7101B03 B3018; N7086B02 B3016; N3818B02 B3048; N3834B01 B3053; N3839B01 B3055. It also announced measures to prevent future cases, such as deepening surveillance actions by suspending or closing establishments found to be distributing adulterated products. Cofepris will also introduce stricter controls of national and international package and courier services involved in the supply and delivery chain and may impose administrative sanctions.

Meanwhile, the Mexican Congress’s Justice Committee on July 27 passed an initiative to prohibit the sale, marketing, distribution and illegal supply of medicines of apocryphal origin which are past their expiry date.  The initiative also modifies the Federal Criminal Code including a special penalty for medicine theft by a public servant from the health sector, which will range from suspension or removal from office to twenty years in prison.

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