Quality Concerns Hits APAC

India is not alone in witnessing adverse events of various drugs. Several countries such as Japan, China, Malaysia, Indonesia and many more have experienced challenges such as contamination, efficacy, and safety issues (with serious adverse events), resulting in drug recalls in the past few years. As with any incident, an in-depth look will bring forth the root of the problem. Let's explore.

- Sanjiv Das

In February 2023, the Drug Regulatory Authority of Pakistan (DRAP) recalled seven products manufactured by Islamabad-based Davis Pharmaceutical Laboratories in Pakistan because of the discovery of ethylene glycol at unacceptable levels.

The likely cause for contamination for KOF Relief Syrup and six other products were due to the using of the same sources of glycerin and propylene glycol. Four of the products, including KOF Relief Syrup, were manufactured for export.

DRAP was expected to take action against the syrup manufacturer, potentially by cancelling its production license and by subsequent arrests.

In June 2023, Pakistan published changes to its drug pricing policy. The revisions cover the definition of the term essential drugs and biologicals, which officials have expanded to cover all strengths of a medicine.

In March 2023, Malaysia’s Drug Control Authority (DCA) also recalled pholcodine-containing cough and cold medicines, citing the risk of anaphylaxis in surgery.

Australia’s Therapeutic Goods Administration (TGA) published a safety alert in February 2023 about Abbott’s FreeStyle LibreLink Android app. The alert describes a fault that could prevent users from receiving information they need to manage their blood sugar levels. According to TGA, users may experience extended periods of signal loss and during this time they won’t receive high or low glucose alarms.

Abbott has taken steps and has released the latest version of the FreeStyle LibreLink app (version 2.8.4), and has recommended Android 13 OS users of the FreeStyle Libre 2 to update their app to this latest version. Abbott has also released the latest version of the FreeStyle Libre 3 app (version 3.4.2).