Days after the Indian drug regulator asked Noida-based Marion Biotech Pvt Ltd to stop all manufacturing activities over the death of 18 children due to respiratory diseases in Uzbekistan, the World Health Organisation (WHO) has issued an alert advisory, saying these cough syrups should not be used for kids.
"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 advisory.
Calling these two cough syrups "substandard (contaminated) products", the WHO said to date, the manufacturer has not provided guarantees to the WHO on the safety and quality of these products. It said both of these products may have marketing authorisations in other countries in the region. Also, they may have been distributed, through informal markets, to other countries or regions, it said, warning people to not use these "substandard products".
Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
Highlighting the risks associated with the products, the WHO said "diethylene glycol and ethylene glycol", found in the cough syrups, are toxic to humans when consumed and can prove fatal. "The substandard products referenced in this alert 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."
In its advice to regulatory authorities and the public, the WHO said it is essential to detect and remove these substandard products from circulation to prevent harm to patients. "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."
The WHO said anyone who has used them or suffered any adverse reaction must seek "immediate medical advice" from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre.
On December 30, 2022, the health ministry's Central Drugs Standard Control Organisation (CDSCO) stopped all manufacturing activities of Marion Biotech until the probe is undergoing. Health minister Mansukh Mandaviya also said the Indian drug regulatory agency was in touch with the national drug regulator of Uzbekistan on the issue.
The health ministry of Uzbekistan on December 27 had said that an internal inquiry conducted by its regulatory agencies found that the deceased children, before admission to hospital treatment, took Dok-1 Max syrup manufactured by Marion Biotech for 2-7 days 3-4 times a day, 2.5-5 ml, which exceeds the standard dose of the drug for children. It also mentioned the preliminary laboratory studies conducted by them found the particular series of Dok-1 Max syrup contained ethylene glycol, a substance that is toxic.