Roche found responsible for faulty production of HIV drug

BASEL, Switzerland Roche has been found at fault for the production of its HIV medication Viracept. The drug was discovered to have impurities and that led to its removal from the market in June.

According to a regulator’s report, the manufacturers’ employees did not clean a holding tank that stored the material for the drug and then allowed the ingredients to mix with ethanol that was used to clean the vat. This, in turn, created a toxic compound later discovered in the drug distributed to patients.

Patients on the drug complained of a strange smell and one complainant reported an incidence of nausea and vomiting.

The investigators provided a conclusion on the matter: “A more general root cause identified by the inspectors was the lack of knowledge and understanding with regard to the manufacturing process” and suggested that this was because the production process was originally purchased from another company.