NEW DELHI (Reuters) – An unnamed broker in Mumbai has provided key ingredients for an Indian-made cough syrup linked to the deaths of more than 70 children in The Gambia, it said. A chemical vendor involved in the shipment told Reuters. .
The World Health Organization last year produced a syrup containing ethylene glycol (EG) and diethylene glycol (DEG), deadly toxins used in car brake fluids by Indian manufacturer Maiden Pharmaceuticals Ltd. Reuters reported in March that these ingredients could be used by bad actors as a replacement for propylene glycol (PG), a key ingredient in syrupy drugs.
Most of the children who died were under the age of five and died of acute kidney injury within days of ingesting the syrup.
The Medicines Agency of India told WHO in December that the propylene glycol used in the syrup was manufactured by Delhi-based pharmaceutical company Goel Pharma Chem and South Korean manufacturer SKC Co Ltd. 011790.KS). Sharad Goel, whose eponymous company is based in North Delhi, purchased ingredients in sealed barrels rather than directly from SKC.
“We purchased propylene glycol from an importer in Mumbai that we purchased from SKC,” Goel told Reuters in February, making the statement for the first time.
“I can’t name the supplier. We have a business relationship that needs to be maintained,” said Goel, adding that the company “has done nothing wrong.” He said his business was “just a trader and we hand over the sealed barrels we get. We can’t do anything with them.”
India’s Medicines Agency said in December that its own tests had found no toxins in the syrup, but factory inspectors had previously found batches of medicines may have been mislabeled. A memo sent to Maiden and reviewed by Reuters revealed that they had found it.
Given this, it’s not disclosed how you can be sure you’ve tested the correct batch. India’s Ministry of Health did not respond to questions regarding the alleged intermediary or other issues raised in this article.
When asked to comment on allegations that there were middlemen in the supply chain, the WHO’s lead investigator said the investigation had reached a “stalemate” due to lack of information from Indian authorities and pharmaceutical companies. .
Rutendo Kwana, WHO’s team leader for substandard and counterfeit medicine cases, told Reuters in an interview on March 31, “If you ask and you’re not told, it’s a dead end.
A WHO spokesman said this week that the only information he received from Indian authorities was that Goel had purchased propylene glycol from SKC, but that no evidence of the transaction was provided. It said it could not confirm the deal with authorities. South Korean regulators did not respond to requests for comment.
Indian regulators said information about raw materials came from Certificates of Analysis (COAs), the standard paper used to track all ingredients in the pharmaceutical supply chain. Maiden said last October that it sources raw materials from “certified and reputable companies.”
