Nigeria's NAFDAC - National Agency for Food and Drugs Administration and Control - has put two Indian drugs under scanner -- a cough syrup (Guaifenesin) and an oral paracetamol. The Nigerian health agency has flagged drug makers from Punjab and Mumbai for making 'substandard and toxic' medicines, reported Business Standard.
Toxins were discovered in a batch of paracetamol produced by the Mumbai-based SyneCare, according to a June 12 notification from NAFDAC. “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,” the NAFDAC stated on its website.
Ethylene glycol and diethylene glycol are considered toxic for human consumption. It's side-effects can cause headache, diarrhoea, vomiting, abdominal pain, inability to pass urine,
and altered mental condition. It can also result in acute kidney injury, which can even be fatal.
Paracetamol is a commonly used drug to treat flu, fever, mild bodyache, headache, sore throat, menstrual cramps etc.
NAFDAC also stated that the drug was manufactured by SyneCare and imported by Liberia-based BVM Pharmacueticals with batch number L220008. NAFDAC, in another notification on June 13, said that in Federated States of Micronesia and Marshall Islands, a batch of contaminated Guaifenesin syrup was identified. WHO was informed about it on April 6, 2023. The samples from the Marshall Islands were found to contain impermissible amount of ethylene and diethylene glycol.
“The stated manufacturer of the affected product is QP Pharmachem Ltd (Punjab, India). The stated marketer of the product is Trillium Pharma (Haryana, India). To date, neither the
stated manufacturer nor the marketer has provided guarantees to WHO on the safety and quality of these products,” NAFDAC stated.
Guaifenesin syrup is used to relieve cough and chest congestion. NAFDAC said that the use of contaminated Guaifenesin is harmful, especially for children and can also prove fatal.
Since 2022, various reports of Indian pharma companies supplying sub-standard contaminated medicines to semi-regulated countries, especially African, have been surfacing.
In June 2023, Sri Lanka raised a complaint against Indiana Opthalmics, a Gujarat-based firm specialising in eye drops, for supplying low-quality products. The Lankan government accused that the eye drops infected more than 30 people.
The Indian drugmakers are under fire since October 2022 for supplying questionable or contaminated drugs to countries like Micronesia, Uzbekistan, Marshall Islands, Gambia etc.