WHO Flags Indian Syrup As Unsafe, Warns Usage Could Cause Even Death

In the latest case of an Indian medicine to be found unsafe abroad, the World Health Organization (WHO) on Tuesday warned that a syrup could cause serious injury or death.

The WHO Medical Product Alert refers to a batch of contaminated Guaifenesin syrup TG identified in the Marshall Islands and Micronesia and reported to WHO on April 6, 2023. Its manufactured by Punjab-based QP Pharmachem Ltd and is marketed by Haryana-based Trillium Pharma. 

To date, neither the stated manufacturer nor the marketer have provided guarantees to WHO on the safety and quality of these products.

This is the latest Indian medicine to raise safety concerns abroad. Earlier, Indian syrups have been linked to deaths in Gambia and Uzbekistan. In the United States, eye drops made by an Indian company are behind an ongoing wave of bacterial infections that have casued death and loss of vision. 

What we know of the latest WHO alert?

The World Health Organisation on Tuesday issued a product alert over contaminated syrup made by Punjab-based QP Pharmachem and marketed by Haryana-based Trillium Pharma.

The WHO warned that the syrup is unsafe for use, especially in children, and may result in serious injury or death.

"The substandard product referenced in this Alert is unsafe and its 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 alert said.

There was no immediate comment from the manufacturer on the WHO alert.

Guaifenesin is an expectorant used to relieve chest congestion and the symptoms of cough.

Samples of the Guaifenesin syrup TG syrup from the Marshall Islands were analysed by quality control laboratories of the Therapeutic Goods Administration (TGA) of Australia. The analysis found that the product contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

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, the alert by the global health agency said.

The alert said that Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.

What did WHO advise?

Who advised that if people have the affected product, they should not use it.

WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised. National regulatory authorities/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country.

Manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, sorbitol, and/or glycerin/glycerol, are urged to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.

Healthcare professionals should report any suspicious cases of adverse events linked to the use of these contaminated medicines to the National Regulatory Authorities/ National Pharmacovigilance Centre, it said.

Latest Indian medicine in question abroad

This is the latest in the line of Indian drugs found unsafe abroad. Earlier, Indian syrups have been linked to deaths in Gambia and Uzbekistan. In the United States, eye drops made by an Indian company are behind an ongoing wave of bacterial infections that have casued death and loss of vision. 

In Gambia and Uzbekistan too, the same ethylene glycol was found to have contaminated the syrups. It is an industrial compound and is toxic to humans.

"Ethylene glycol and its toxic byproducts first affect the central nervous system (CNS), then the heart, and finally the kidneys. Ingesting enough can cause death. Ethylene glycol is odorless," says US Centers for Disease Control and Prevention (CDC).

In Gambia, the syrup was made by Maiden Pharmaceuticals and the syrup in question in Uzbekistan was made by Uttar Pradesh's Noida-based Marion Biotech.

Besides these two episodes, eye drops made by Chennai-based Global Pharma Healthcare are linked to an ongoing wave of infections in the United States that have caused dozens of infections and even deaths and loss of vision in people. 

Moreover, several Indian companies have also been forced to recall products in the United States over poor quality in recent time. 

In February, Indian drug-maker Lupin Limited recalled 5,720 tubes of a skin medicine over quality issues, according to US Food and Drug Administration (FDA). The skin cream is used in the treatment of various skin conditions, such as dermatitis, eczema, and psoriasis.

The February recall was the latest recall by Lupin, which had to make a series of recalls over quality issues over the past one year.

In January 2023, Lupin recalled 16,056 bottles of Rifampin Capsules used in the treatment of all forms of tuberculosis. The recall was observed after impurities were detected and the drug failed stability test. 

In December 2022, Lupin recalled blood pressure medicine Quinapril over impurities in the tablets. The prolonged use of the impurity detected can cause cancer, WebMD quoted FDA as saying.

In September 2022, Lupin recalled 7,872 bottles of same Rifampin Capsules which were also recalled last month. The recall was for manufacturing lapses. 

In January 2022, Lupin recalled 50,832 bottles of anti-bacterial medicine Gatifloxacin Ophthalmic Solution. It's used in eye treatment. The recall was ordered after failing stability tests. 

In January 2022, it was also reported that Lupin was recalling 23,965 bottles of Oxycodone Hydrochloride tablets. The tablets are used for the treatment of moderate to severe pain.

(With PTI inputs)