“Two cough syrups made by India’s Marion Biotech should not be used for children after the products were linked to 19 deaths in Uzbekistan,” the WHO said on Wednesday. The products are AMBRONOL syrup and DOK-1 Max syrup.
On December 27 Uzbekistan health ministry had said that 18 children had died allegedly after consuming the cough syrups.
The Drugs Controller General of India has initiated a probe in connection with the incident. Earlier Union health minister Mansukh Mandaviya said further action would be taken based on an inspection of Marion Biotech’s facilities in Noida, Uttar Pradesh. However, ministry and the regulatory body is yet to take further steps.
“To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” the WHO said.
Substandard medical products are products that fail to meet quality standards or specifications and are therefore “out of specification”.
According to the WHO, 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 /or ethylene glycol as contaminants.
The UN agency said that the products are “unsafe and their use, especially in children, is likely to 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,” it said.
Following this, the WHO has advised the regulatory authorities and the public at large to detect and remove these substandard products from circulation to prevent harm to patients. It also asked for increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products.
It also asked them to notify the WHO if the substandard products are discovered in their country.
The WHO has urged the manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, polyethylene glycol, sorbitol, and/or glycerin/glycerol, to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.
A few months ago, Gambia reported a similar incident wherein 70 children died due to the ingestion of a cough syrup allegedly manufactured by Sonipat-based Maiden Pharmaceuticals, following which its unit was shut for violating manufacturing standards.