WHO warns against contaminated cough syrup made by Punjab-based pharma co

The World Health Organisation (WHO) on Tuesday said a cough syrup made by a Punjab-based company has been found to be contaminated and that these were being sold in the Marshall Islands and Micronesia.

The contaminated syrup, Guaifenesin Syrup TG Syrup, which is an expectorant used to relieve chest congestion and the symptoms of cough, was reported to the WHO on April 6, 2023.

As per the WHO, the Guaifenesin syrup samples collected from the Marshall Islands were analysed by the quality control laboratories of the Therapeutic Goods Administration (TGA) of Australia. It found the product contained "unacceptable amounts of diethylene glycol and ethylene glycol as contaminants". Diethylene glycol and ethylene glycol are considered toxic to humans when consumed and can prove fatal.

Health experts say such substandard products are unsafe and their use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury, which may lead to death.

The WHO has said to date, the manufacturers of the product, QP Pharmachem Ltd (Punjab, India) and marketer Trillium Pharma (Haryana, India), have not provided guarantees on the safety and quality of these products.

"The product referenced in this alert may have marketing authorisations in other countries in the Western Pacific region. It may have also been distributed, through informal markets, to other countries or regions," warned the global health body.

The WHO has advised against using this product and called for immediate medical advice if anyone may have used the affected product, or suffered an adverse reaction. It has also requested increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products.

In January 2023, the WHO issued an alert advisory, saying certain cough syrups made by Noida-based Marion Biotech Pvt Ltd were “substandard”, and that their use, especially in children, may result in “serious injury or death”.

"The two products are AMBRONOL syrup and DOK-1 Max syrup. The stated manufacturer of both products is MARION BIOTECH (Uttar Pradesh, India). Laboratory analysis found both products contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants," the WHO said in its global advisory.

Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan, also found that both products contained "unacceptable amounts of diethylene glycol and ethylene glycol" as contaminants.

Before that, the national pharmaceutical regulatory body Central Drugs Standards Control Organisation (CDSCO) had flagged five cough syrup samples produced by Maiden Pharmaceuticals at its Baddi plant in Himachal Pradesh as "not of standard quality" or spurious".

The syrup batches flagged by the government body were cough syrups for throat and chesty coughs, manufactured in August 2021 and they will expire in July 2024. The reasons for failing the quality standard were mentioned as the assay of codeine phosphate & menthol; assay of codeine phosphate, among others.