NEW DELHI: A chemicals trader told Reuters that an unnamed Mumbai middleman supplied a crucial raw material used in Indian-made cough syrups linked to over 70 Gambia child deaths.
The syrups from Indian manufacturer Maiden Pharmaceuticals Ltd. contained lethal ethylene glycol (EG) and diethylene glycol (DEG), used in car brake fluid. These ingredients cost half as much as propylene glycol (PG), a syrupy medicine base, according to Reuters.
Acute kidney injury killed most under-5s within days of taking the syrups.
In December, India’s drugs regulator informed the WHO that the syrups’ propylene glycol came from Delhi-based pharma-supplies company Goel Pharma Chem and was “recorded to have been imported” from SKC Co Ltd.
Sharad Goel’s north Delhi company bought the ingredient from sealed barrels, not 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,” Goel said, adding that his company “not done anything wrong. “We just trade sealed barrels,” he said. They’re useless.”
Reuters couldn’t verify Goel’s claim. He buys most of his products from 8-10 importers and sold starch but not PG after the Gambia poisonings.
Goel closed his business after a reporter called twice in April. Factory workers claimed it hadn’t opened in months.
Moreover, SKC denied giving Reuters Goel or Maiden PG.
While, Goel’s claim suggests gaps in Gambia, India, and WHO contaminated product investigations. The WHO and Gambia’s government say India’s lack of information slowed the investigation.
Moreover, India’s drugs regulator informed Maiden that factory inspectors found mislabeled medicine batches.
How did it test the right batch?
Indian Health Ministry
India’s health ministry ignored the intermediary and other issues.
The WHO’s lead investigator called the supply chain middleman claim a “dead end” due to Indian authorities and drugmaker lack of information.
“If you ask and don’t get informed, it’s a dead end,” WHO team lead for substandard and falsified medicines Rutendo Kuwana told Reuters on March 31.
This week, a WHO spokesperson said Indian authorities only told them Goel bought propylene glycol from SKC, but no evidence of the trades. WHO and Korean regulator have not confirmed that transaction. Korean regulators were silent.
COAs tracked drug ingredients for India’s regulator. Last October, Maiden said it bought raw materials from “certified and reputed companies.”
While, India’s health ministry told the WHO that Maiden’s syrups did not kill Gambia and “adversely impacted the image” of its $41 billion pharmaceutical industry.
Maiden CEO Naresh Kumar Goyal told Reuters his company did nothing wrong in December. Delhi maiden declined comment.
Gambia’s Medicines Control Agency said Maiden and Indian authorities hadn’t responded “despite our request for information after the discovery of the tainted products.”
Kuwana told Reuters the WHO is investigating Maiden’s products. According to WHO alerts, the agency is also investigating the supply chains of two other Indian drugmakers that sold contaminated cough syrups in Uzbekistan and the Marshall Islands and Micronesia. Both companies deny wrongdoing; Indian police arrested three employees of one in March.
Moreover, In January, Uzbekistan arrested four for that. They and Micronesia officials declined comment.
