An unnamed middleman in Mumbai provided a crucial raw material used in Indian-made cough syrups that have been linked to the deaths of more than 70 children in Gambia, a chemicals trader involved in the supply chain told Reuters.
The World Health Organization said last year the syrups, made by Indian manufacturer Maiden Pharmaceuticals Ltd, contained lethal toxins ethylene glycol (EG) and diethylene glycol (DEG) – used in car brake fluid.
These ingredients can be used by unscrupulous actors as a substitute for propylene glycol (PG), which is a key base of syrupy medicines – because they can cost less than half the price, as Reuters reported in March.
The children who died were mostly under age 5 and 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 Co Ltd 011790.KS.
Sharad Goel, whose eponymously named 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, speaking out for the first time.
“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.” He said his business was “just a trader and we pass on sealed barrels that we get. We can do nothing with them.”
Reuters could not independently confirm Goel’s assertion. He said that after the Gambia poisonings, his company had stopped selling PG but continued to supply other products such as starch, and that he generally buys most of his products from 8-10 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 they had not seen it opening in 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 labeled, according to a notice it sent to Maiden seen by Reuters.
It has not made clear how, in light of that, it can be sure it tested the correct batch.
India’s health ministry did not respond to questions about the alleged intermediary or about any of the other issues raised in this story.
Asked to comment on the claim there was a middleman in the supply chain, the WHO’s lead investigator said inquiries have reached a “dead end” due to a lack of information from the Indian authorities and the drugmaker.
“If you ask and you don’t get informed, it’s a dead end,” Rutendo Kuwana, the WHO’s team lead for incidents with substandard and falsified medicines, told Reuters in an interview on March 31.
A WHO spokesperson said this week that the information it has received from Indian authorities so far is only that Goel bought propylene glycol from SKC, but that no evidence of the trades was provided. The WHO said it also has not been able to confirm that transaction with the Korean regulator. The Korean regulator did not respond to a request for comment.
India’s regulator said its information on the raw materials came from certificates of analysis (COAs) – 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.”
As well as denying that Maiden’s syrups are connected to the deaths in Gambia, India’s health ministry has told the WHO that its allegations “adversely impacted the image” of the country’s $41 billion pharmaceutical industry.
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. A Maiden representative in its New Delhi headquarters also declined to comment.
Gambia’s Medicines Control Agency also said it had not received any information from Maiden or the Indian authorities “despite our request for information after the discovery of the tainted products.”
(REUTERS)