By Krishna N. Das and Jennifer Rigby
NEW DELHI/LONDON (Reuters) -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.
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.”
The WHO’S Kuwana told Reuters his agency is still intent on finding out what happened with Maiden’s products. The WHO is also trying to find out more about the supply chains of two other Indian drugmakers who produced contaminated cough syrups sold in Uzbekistan and the Marshall Islands and Micronesia, according to alerts published by the agency. Both companies deny wrongdoing; Indian police arrested three employees of one of them in March.
Authorities in Uzbekistan arrested four people in January in relation to that case. Neither they nor the authorities in Micronesia responded immediately to requests for comment.
VIOLATIONS
Maiden has a track record of production issues. In February, an Indian court sentenced two of its executives, Managing Director Goyal and Technical Director M.K. Sharma, to two-and-half years in jail for exporting substandard drugs to Vietnam nearly a decade ago.
The court gave them a month to appeal; Reuters could not ascertain the status of the case. Goyal did not respond to requests for comment; neither Sharma nor his lawyer could be reached. The Maiden representative declined to comment.
Drug inspectors found a dozen violations at Maiden last October related to the production of the cough syrups sold to Gambia, a government document showed. Among these, some of the COAs of raw ingredients used in making the syrups, including propylene glycol, were missing batch numbers. Others lacked manufacturing and expiry dates.
Four industry and regulatory experts told Reuters this means that there could be no reliable record of where the ingredients came from.
The government inspectors also found Maiden had failed to test the PG used in the syrups. They cited discrepancies in the documentation of the finished products – the labels on the syrup bottles said they were made in December 2021 but batch manufacturing records pointed to later dates, between February and March in 2022.
This mismatch would make it difficult for government testers to be certain the medicines they were analysing were the same as those sent to Gambia, according to a former Indian health ministry official.
“There is complete discordance in the data in the labels and the batch records, which raises questions about the genuineness of the product,” said Kundan Lal Sharma, who was in charge of drug and food regulation in the health ministry between 2014 and 2017.
“This means something has been cooked up,” he said. “Nobody can guarantee anything unless proper documentation is there.”
India’s health ministry has declined to say how it verified that the syrups tested by its labs came from the same batches and Maiden has not responded to questions about the labeling or documentation.
Kuwana said the WHO was sure of its own cough syrup test results from two separate independent laboratories, both of which showed contamination.
He said the agency has not seen the full results of the tests conducted on the syrups by the Indian government, or the COAs for the raw materials or finished products sampled, despite repeated requests.
The agency says it is now reviewing its guidelines on how countries should police raw materials in medicines, based on the recent events.
Asked how it was possible that test results from the WHO and India did not match, Kuwana said that in past incidents of adulterated medicines, a manufacturer has substituted samples for testing that did not represent what was on the market. The WHO is not aware whether that happened in this case, he said.
“Normally when that happens, it is because we haven’t tested the same sample,” said Kuwana.
(Additional reporting by Edward McAllister in Senegal, Joyce Lee in Seoul, Devjyot Ghoshal in New Delhi, John Mair in Sydney; Edited by Sara Ledwith and Michele Gershberg)
