New Delhi: The Nigerian drug control agency has issued public announcements against two drugs – oral paracetamol and a cough medicine – manufactured in India, by companies based in Mumbai and Punjab, for being “sub-standard or found to be containing toxins”.
Nigeria’s National Agency for Food and Drugs Administration and Control (NAFDAC) said on June 12 a batch of oral paracetamol suspension manufactured by Mumbai-based SyneCare contained toxins. “Laboratory analysis of the sample confirms that the product contains toxic ethylene glycol, a toxic substance that is not expected in product formulations. The product also failed the requirement for acute oral toxicity with five deaths of the laboratory animals recorded,” NAFDAC said.
“Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. 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 continued.
This drug was manufactured by SyneCare in Mumbai and imported by BVM Pharmaceutical, Liberia.
In another notification a day later, NAFDAC said Guaifenesin, a cough syrup manufactured in Punjab, “contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants” when analysed by quality control laboratories in Australia.
“To date, neither the stated manufacturer nor the marketer [in Haryana] have provided guarantees to WHO on the safety and quality of these products,” it continued.
The substandard batch of this drug were identified in the Marshall Islands and Federated States of Micronesia, and reported to WHO on 6 April 2023, NAFDAC.
“The contaminated Guaifenesin syrup 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 Nigerian authority said. “…Members of the public in possession of the above-mentioned product are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.”
On April 25 this year, the WHO had issued an alert against Guaifenesin TG Syrup, saying was found to have diethylene glycol (DEG) and ethylene glycol (EG) – two contaminants which were also found in medicines exported by Indian makers to Uzbekistan and Gambia earlier. However, the manufacturer has told The Wire that while this syrup is sold in India, the allegations have been levelled against a counterfeit product.