WHO issues global alert after DRAP detects falsified cough syrup raw materials in Pakistan

ISLAMABAD: Following the discovery of ‘toxic impurities’ in imported raw materials for cough syrup production in Pakistan earlier this year, the World Health Organization (WHO) issued an advisory on Monday, urging manufacturers worldwide to acquire raw materials from qualified and approved suppliers.

The advisory comes after revelations that used containers of the multinational company were employed to supply ‘falsified’ pharmaceutical raw materials.

“Manufacturers of oral liquid medications, particularly cough syrups containing ingredients susceptible to contamination with ethylene glycol (EG) and/or diethylene glycol (DEG), such as propylene glycol, sorbitol, and/or glycerin/glycerol, must strictly adhere to WHO good manufacturing practice requirements,” the WHO emphasized in its latest medical product alert.

In January 2024, the Drug Regulatory Authority of Pakistan (DRAP) launched a nationwide investigation to identify and recall propylene glycol used in cough syrup production after “toxic impurities” were detected during testing at the Central Drug Testing Laboratory (CDL) in Karachi.

DRAP investigators suspect that local vendors used emptied containers from a multinational pharmaceutical raw materials manufacturer based in Thailand, to supply “falsified” and contaminated propylene glycol containing EG and DEG.

Experts explain that propylene glycol is a common excipient, an inactive pharmaceutical ingredient, used in syrups, especially cough syrups. However, some companies attempt to cut corners by utilizing industrial-grade propylene glycol, which is unsafe for human consumption due to its dangerously high levels of ethylene glycol and diethylene glycol.

Tragically, hundreds of children in various countries have lost their lives after consuming cough syrups containing poisonous impurities like EG and DEG exported by some Indian companies. Additionally, the WHO recently identified cough syrups manufactured by a Lahore-based company circulating in Maldives and other countries.

WHO medical alert highlighted DRAP’s investigation into potential contamination of oral liquid medicines. The investigation led to the identification of suspicious propylene glycol drums, which were subsequently tested by Pakistan’s Central Drugs Laboratory.

“Analyses revealed unacceptable levels of ethylene glycol contamination, ranging from 0.76 percent to 100 percent. Between January and March 2024, DRAP issued three rapid alerts regarding five contaminated batches,” the WHO stated in its latest medical product alert.

The WHO further confirmed with the firm that the raw materials identified in the DRAP alerts and the WHO alert were not manufactured or supplied by them. Consequently, the quality and safety of these excipients could not be guaranteed.

The WHO medical product alert strongly warns that the propylene glycol materials identified are likely deliberately and fraudulently mislabeled. “They contain high levels of ethylene glycol, which can be toxic if ingested,” the alert emphasizes.

These contaminated raw materials may have been distributed to other countries, potentially through informal or unregulated markets. Manufacturers of oral liquid medicines may have unknowingly purchased these materials, which could still be present in their storage facilities.

The falsified raw materials referenced in the alert should be considered unsafe, and their use in medical products may result in serious injury or death, particularly in children. Symptoms of poisoning can include abdominal pain, vomiting, diarrhoea, difficulty urinating, headache, altered mental state and acute kidney injury, which can be fatal, the WHO alert warns.