Substandard Cough Syrups, other Drugs now in Markets – NAFDAC warns Nigerians

Substandard drugs

The National Agency for Food and Drug Administration and Control has warned against the use of two Indian cough syrups found in Uzbekistan.

The agency said the syrups, Ambronol syrup and DOK-1 Max syrup, are substandard.

Substandard medical products are products that fail to meet quality standards or specifications and are therefore out of specification.

The agency had taken action in October against the use of four India-made cough syrups linked to the deaths of 66 children in The Gambia.

The alert tagged “Public Alert No. 02/2023,” obtained by TENET on the agency’s Twitter and website on Monday, noted that 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.

It said the manufacturer of both products is Marion Biotech Private Limited, Uttar Pradesh, India.

The public alert read, “To date, the stated manufacturer has not provided guarantees to the World Health Organisation on the safety and quality of these products.

“Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhoea, the inability to pass urine, headaches, altered mental state, and acute kidney injury, which may lead to death.

“These substandard products are therefore unsafe, and their use, especially in children, may result in serious injury or death.”

NAFDAC also urged manufacturers of 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.

“Although the products are not in the NAFDAC database, importers, distributors, retailers, and consumers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the substandard (contaminated) syrups.

“All medical products must be obtained from authorised/licensed suppliers. The products’ authenticity and physical condition should be carefully checked,” it said.

NAFDAC also warned Nigerians who have the products to discontinue sale or use and submit stock to its office.

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