DRAP Issues Rapid Alert for Contaminated Batch of Propylene Glycol Used in Cough Syrups

In a significant development concerning public health, the Drug Regulatory Authority of Pakistan (DRAP) has issued a rapid alert and it has taken prompt action after the discovery of a contaminated batch of Propylene Glycol (PG) in the production of oral liquid preparations such as cough syrups. Customs at the airport pulled up the batch of Propylene Glycol (PG) with the label of Dow Chemical, Thailand, which was flagged after a test at Central Drug Laboratory in Karachi, which proved an alarming discovery of Ethylene Glycol (EG).

Problem Unveiled

Regulatory field force found that batch (C815N30R41) of Propylene Glycol was contaminated with an unsafe amount of Ethylene Glycol, which can cause serious health problems. Ethylene Glycol contamination in oral liquid preparations causes toxicity, affecting the central nervous system, heart, and kidneys, which may lead to fatal outcomes.

Regulatory Response

The Regulatory Field Force has started a comprehensive investigation into the matter and it is seizing products manufactured from the contaminated batch. Moreover, the manufacturer of therapeutic goods has been directed to recall all the finished products produced using the same lot of Propylene Glycol. At the same time, the field force has been directed to seize any oral preparations utilizing the tainted batch if found in the market

DRAP Directives to Industry

Furthermore, the manufacturers of therapeutic goods are directed to recall products associated with the contaminated batch, hold finished products from other lots of Propylene Glycol from Dow Chemical Thailand for testing, screen all materials for contamination, and test both materials and products for EG/DEG contamination. Harsh adherence to DRAP directives and a strict following of the pharmacopoeia monograph and WHO guidelines have been directed.

Ensuring Public Safety

DRAP emphasizes its concern about public safety and it is actively working with the industry to ensure stringent quality control measures are taken. The regulatory authority highlights the necessity of proper testing protocols to avoid any possible injuries as a result of tainted products.

Guidance for Healthcare Professionals

Healthcare professionals must keep up-to-date with advisories and recalls and counsel patients about risks of EG toxicity, manage patients taking the implicated products closely and report any adverse events promptly to pharmacovigilance centers.

Consumer Awareness

Consumers should keep themselves updated about DRAP advisories, should consult a doctor immediately if they have unusual symptoms post usage of oral liquid preparations like cough syrups and report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. Everyone should seek out therapeutic goods from licensed sources and make sure that the genuineness of the products is guaranteed.

This regulatory response is aimed at swiftly isolating and responding to the possible health risks associated with the polluted batch. DRAP continues to be dedicated to protecting public health and emphasizes a combined effort from product manufacturers, healthcare professionals, and consumers to maintain the highest standards in terms of safety and quality in therapeutic goods.