SWITZERLAND — Pharmaceutical experts are raising concerns over Sandoz’s refusal to reveal the name of the European contract manufacturing organization (CMO) responsible for the contamination of the antibiotic Dicillin.

The antibiotic Dicillin Sandoz 500 mg capsules have been at the center of a scandal involving bacterial contamination and the ensuing health risks.

Patients who have been prescribed this medication have been instructed to return it to a pharmacy and have it replaced with another antibiotic to continue their treatment.

The Danish Medicines Agency has reported that a small number of patients treated with Dicillin 500 mg have been infected with multi-resistant CPO bacteria, which may have originated from the medication.

Over the past four months, nine confirmed cases of the bacteria have been found in unrelated patients, with the contamination suspected to have come from a single batch of Dicillin manufactured in September 2022.

In response to the scandal, Sandoz has recalled all Dicillin packages and placed them in quarantine. It is still under investigation whether only one batch or a larger selection of Dicillin has been contaminated.

The name of the CMO that made the drug is a trade secret, Sandoz claims. Sandoz considers itself obligated to keep information related to partners’ identities secret.

The situation has raised concerns about the safety and efficacy of pharmaceutical quality control, and the need for increased transparency and accountability in the industry.

Despite repeated requests from regulators and industry experts, Sandoz has refused to disclose the identity of the CMO responsible for the tainted batches.

This lack of transparency has sparked criticism, with some experts arguing that it is essential to hold the responsible party accountable and prevent similar incidents from occurring in the future.

Sandoz, a division of the pharmaceutical giant Novartis, has defended its position, stating that it has already taken the necessary corrective measures and that the identity of the CMO is confidential information.

Sandoz marketed the antibiotic product that has now been withdrawn from the Danish and Icelandic markets.

The latest development in the case involves the Danish Serum Institute (SSI), which has reported two new cases of bacteria linked to Dicillin treatment, as well as traces of the Carbapenemase-producing bacteria in 12 additional individuals.

The SSI’s findings have raised alarms about the safety and efficacy of Dicillin, which is prescribed to treat bacterial infections.

Carbapenemase-producing organisms (CPO) are a type of bacteria that are resistant to multiple antibiotics, making them challenging to treat, according to information from the Danish Health Authority.

While healthy individuals are at low risk of becoming seriously ill due to CPO, those who are already ill or vulnerable are at increased risk.

In addition to the health risks, infection with multiresistant bacteria such as CPO can also result in all future hospital treatments being given in isolated rooms to prevent the spread of the bacteria to other patients.

In October of last year, the Danish Serum Institute (SSI) first detected a specific type of CPO that it had not seen before.

Initially, the source of the bacteria was suspected to be hospitals or overseas travel before being linked to the antibiotic medication Dicillin in February.

The contamination appears to be the result of a manufacturing issue, with the exact cause still under investigation.

The implications of this scandal are significant, as it calls into question the effectiveness of pharmaceutical quality control and the potential risks to public health.

The recall of tainted Dicillin batches, as well as the SSI’s findings, highlight the need for increased transparency and accountability in the pharmaceutical industry.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.