Two more Indian drugmakers under scanner for contaminated medicines

The Nigerian health agency has flagged off two drugs — oral paracetamol and another cough medicine — manufactured 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) found a batch of oral paracetamol suspension manufactured by Mumbai-based SyneCare containing toxins, it said in a notification dated June 12. “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 said in an alert notification on its website.

Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal, it added. The effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury that might even prove fatal.

Paracetamol suspension is used for treating mild to moderate aches, such as headache, migraine, neuralgia, toothache, sore throat, menstrual pains, etc. It is also used in cases of fever and for cold and flu.

The Nigerian health agency further noted that the product was manufactured by SyneCare in Mumbai and imported by BVM Pharmaceutical, Liberia. The batch number of the suspension is L220008. In another notification dated June 13, it said a batch of sub-standard or contaminated Guaigenesin syrup was identified in Marshall Islands and Federated States of Micronesia, and was reported to the WHO on April 6, 2023. Samples of the syrup from Marshall Islands were analysed by quality control laboratories of the Therapeutic Goods Administration (TGA) of Australia. The analysis found that the product contained unacceptable amounts of diethylene glycol and ethylene 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 is an expectorant used to relieve chest congestion and the symptoms of cough. It works by thinning and loosening mucus in the airways, clearing congestion, making breathing easier.

The contaminated Guaifenesin syrup is unsafe and its use, especially among children, may result in serious injury or death, it said.

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.

While QP Pharmachem could not be reached for comment, no one at the SyneCare office responded to calls.

There have been multiple reports of contaminated and substandard medicines made in India and exported to semi-regulated countries since the end of last year.

Earlier this month, the Central Drugs Standard Control Organisation (CDSCO) was investigating a complaint raised by Sri Lanka that Gujarat-based Indiana Ophthalmics’ eye drops are linked to infections in more than 30 people. Since October last year, Indian exporters have been under fire and several cases of sub-standard or contaminated drugs made in India and supplied to Gambia, Uzbekistan, Marshall Islands, Micronesia were reported.