WHO red flags Punjab made cough syrup in fresh medical alert

In yet another case of contaminated cough syrup supplied by an Indian manufacturer, the World Health Organisation (WHO) on Tuesday issued a global product alert over the manufacturing and marketing of contaminated cough syrup by QP Pharmachem Ltd and Trillium Pharma.

The cough syrup, manufactured in Punjab and marketed by the Haryana firm had toxic contaminants, the WHO said on Tuesday, flagging a fresh instance of substandard drugs from India.

The latest medical product alert refers to a batch of substandard (contaminated) Guaifenesin syrup TG syrup identified in the Marshall Islands and Micronesia. It was reported to WHO on April 6, 2023.

As per the analysis of the product samples of the cough syrups, there were “unacceptable amounts of diethylene glycol and ethylene glycol” as contaminants, chemicals toxic to humans that can prove fatal when consumed, said WHO in the medical alert.

“The analysis found that the product contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. The stated manufacturer of the affected product is QP Pharmachem (Punjab, India). The stated marketer of the product is Trillium Pharma (Haryana, India),” the world body said.

“To date, neither the stated manufacturer nor the marketer has provided guarantees to WHO on the safety and quality of these products,” it said.

According to WHO, it had identified the product in its Western Pacific Region and said that the product may have also been distributed through informal markets to other countries or regions.

Samples of the syrup from the Marshall Islands were analysed by quality control laboratories of the Therapeutics Goods Administration, Australia’s drug regulatory authority. The TGA analysis found the product to contain the two contaminants.

The syrup contains a compound called guaifenesin, an expectorant used to relieve chest congestion and symptoms of cough.

The WHO stated that the product is unsafe for use, especially in children, and may result in serious injury or death. The toxic effects can include abdominal pain, vomiting, diarrhoea, headache, and acute kidney injury that may lead to death.

Manufacturers producing liquid dosage forms, especially syrups, are advised to test for the presence of contaminants such as ethylene glycol and diethylene glycol. This is the fourth red flag involving Indian-made drugs.

WHO had issued a medical alert in October last year, allegedly linking the death of over 66 Gambian children to cold and cough formulations made by Sonepat-based Maidan Pharma.

In December last year, Uzbekistan health ministry reported 18 child deaths allegedly from consuming a cough syrup made by Noida-based Marion Biotech and most recently in April 2023, the USFDA linked Chennai-based Global Pharma-made eye drops to three deaths and blindness in the US.

The global health body has also advised not to use the syrup. “If you have the affected product, WHO recommends that you do not use it. If you, or someone you know, has or may have used the affected product, or suffered an adverse reaction or unexpected side-effect after use, you are advised to seek immediate medical advice from a healthcare professional.”

WHO asked member states for increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products.

The union health ministry is yet to respond.