Another batch of contaminated Indian-made cough syrup has been found, with the WHO saying the tested samples of Guaifenesin TG syrup showed “unacceptable amounts of diethylene glycol and ethylene glycol”, toxic substances used in car brake fluid.
Both compounds could be fatal if consumed, and have previously been linked to other Indian-made cough syrups associated with child deaths in The Gambia and Uzbekistan, reports the BBC. They are sometimes used as a substitute for propylene glycol (PG), a key base of syrupy medicines, because they cost less than half the price.
Sudhir Pathak, managing director of QP Pharmachem which manufactures the cough syrup, said the company had exported the batch of 18 346 bottles to Cambodia after getting all due regulatory permissions. He didn’t know how the product had reached the Marshall Islands and Micronesia, where the latest incidents were recorded.
“We did not send these bottles to the Pacific region, and they were not certified for use there,” he said, adding that his company has sent a legal notice to the firm that exported the batch of medicines to Cambodia.
The syrup was marketed by Trillium Pharma, based in Haryana state. The BBC couldn’t reach a Trillium representative and the Indian Government has not reacted to the latest alert.
Why Indian drugs spark concern
India is the world’s largest exporter of generic drugs, meeting many of the medical needs of developing countries.
But in the past few months, a number of local firms have come under scrutiny for the quality of their drugs, with experts raising concerns about the manufacturing practices used to make these medicines.
Meanwhile, Reuters reports that an unnamed middleman in Mumbai has been blamed for providing a crucial raw material used in the Indian-made cough syrups linked to the deaths of the 70 children in The Gambia.
The WHO said last year that the syrups made by Maiden Pharmaceuticals had contained the lethal toxins ethylene glycol and diethylene glycol.
The children, mostly under five, died of acute kidney injury, some within days of taking the syrups.
India’s drugs regulator told the WHO in December that the propylene glycol used in the syrups came from Goel Pharma Chem, a Delhi-based pharma-supplies company, and was “recorded to have been imported” from South Korean manufacturer SKC.
Sharad Goel, whose company is based in north Delhi, said he had bought the ingredient in sealed barrels, but not directly from SKC.
“We bought the propylene glycol from an importer in Mumbai who bought it from SKC,” Goel told Reuters in February.
“I can’t name the supplier. We have business links that we need to keep,” said Goel, adding his company had “not done anything wrong”. “We are just a trader and we pass on sealed barrels that we get.”
Reuters could not independently confirm Goel’s assertion. He said that after the Gambian poisonings, his company had stopped selling PG but continued to supply other products such as starch, and that he generally buys from about eight or 10 importers.
Goel subsequently stopped answering calls and when a reporter called at his business twice in April, it was locked. Workers at a neighbouring factory said it had been closed for the past few months.
SKC told Reuters it had never supplied any PG either to Goel or to Maiden.
If true, Goel’s claim would point to a missing link in investigations by Gambia, India and the WHO into the contaminated products. The clue comes as the WHO and Gambia’s government say the search for a culprit has been stymied by a lack of information from India.
India’s drugs regulator said in December its own tests found no toxins in the syrups, but its factory inspectors did earlier find that batches of medicine may have been incorrectly labelled.
A WHO spokesperson said this week that the information it has received from Indian authorities so far was only that Goel bought propylene glycol from SKC, but that no evidence of the trades was provided.
India’s regulator said its information on the raw materials came from certificates of analysis – standard paperwork used to track each ingredient in a drug supply chain. Maiden said last October that it had obtained raw materials from “certified and reputed companies”.
Maiden’s boss, Naresh Kumar Goyal, told Reuters in December his company did nothing wrong, and did not respond to further questions for this story.
The WHO is still intent on finding out what happened with Maiden’s products and about the supply chains of two other Indian drugmakers who produced the other contaminated cough syrups sold in Uzbekistan and the Marshall Islands and Micronesia,
Both companies deny wrongdoing.
Reuters article – Indian cough syrup: mystery middleman may be new clue (Open access)
BBC News article – Guaifenesin: WHO issues alert over another India-made cough syrup (Open access)
See more from MedicalBrief archives:
Probe into Indian cough syrup link to Gambian children’s deaths
India cancels licence of company linked to deadly cough syrups
India issues product ban after cough syrup deaths