Possible new lead in the case of the elusive Indian cough syrup middleman.
An intermediary supplied an essential ingredient for cough syrups made in India that have been connected to the deaths of 70 children in Gambia.
A chemicals merchant involved in the supply chain told Reuters that an unnamed intermediary in Mumbai supplied a key raw material used in Indian-made cough syrups that have been connected to the deaths of more than 70 children in Gambia.
Ethylene glycol (EG) and diethylene glycol (DEG) — found in automotive brake fluid — were identified as carcinogens by the World Health Organization last year in syrups produced by the Indian company Maiden Pharmaceuticals Ltd. According to a Reuters article from March, these substances can be utilized as a cheaper alternative to propylene glycol (PG), the main ingredient in syrupy medicines.
Most of the victims were younger than five years old, and they all died from severe renal impairment, some just days after ingesting the syrups.
In December, India’s medicines authority informed the WHO that the syrups’ propylene glycol originated from Delhi-based pharma-supplies company Goel Pharma Chem and was “recorded to have been imported” from South Korean producer SKC Co Ltd.
North Delhi-based businessman Sharad Goel, whose company bears his name, claimed to have purchased the component in sealed barrels, though not from SKC.
“We bought the propylene glycol from an importer in Mumbai who bought it from SKC,” Goel revealed to Reuters for the first time in February.
As for the supplier, Goel stated, “I can’t name the supplier – we have business links that we need to keep,” adding that his firm “not done anything wrong.” “We’re just a trader,” he summed up his company’s operations. Nothing can be done with them.
Reuters was unable to verify Goel’s claim on its own. He stated that his firm had ceased selling PG after the Gambia poisonings but that it still supplied other things like starch, adding that he typically purchases most of his supplies from 8-10 importers.
After that, Goel stopped returning phone calls, and the door to his office was closed both times a reporter tried to visit in April. Employees at a nearby factory reported not seeing it open in recent weeks or months.
SKC informed Reuters that it had never given Goel or Maiden any PG.
If Goel’s assertion is correct, it would provide crucial information that has been lacking from the investigations conducted by Gambia, India, and the WHO into the tainted goods. The World Health Organization and the government of Gambia have both reported that a lack of information from India has hampered their investigation for the source of the outbreak.
While the Indian drugs watchdog said in December that it had conducted its own tests and found no toxins in the syrups, a notice sent to Maiden by the watchdog and seen by Reuters indicated that factory inspectors had previously found that batches of medicine may have been incorrectly labeled.
It has not explained how it knows it tested the right batch in light of this.
The Indian health ministry did not address any of the problems or concerns mentioned in this article, including the purported intermediary.
When asked about allegations of a middleman in the drug’s distribution chain, the WHO’s top investigator stated the organization had hit a “dead end” due to a lack of cooperation from the Indian government and the manufacturer.
“If you ask and you don’t get informed, it’s a dead end,” Rutendo Kuwana, the WHO’s team head for incidents with defective and fraudulent medications, said in an interview with Reuters on March 31.
The World Health Organization (WHO) has only been told by Indian authorities that Goel purchased propylene glycol from SKC, according to a WHO representative this week. The WHO also stated that it was unable to verify the deal with the Korean government. The Korean government agency that was asked for comment did not provide one.
Certificates of analysis (COAs) are routine paperwork used to trace each ingredient throughout a medicine supply chain, and the Indian regulator said that this is where they obtained their data on the raw materials. During an October 2018 earnings call, Maiden claimed that it sourced its raw materials from “certified and reputed companies.”
India’s health ministry told the WHO that the accusations “adversely impacted the image” of India’s $41 billion pharmaceutical industry and that they also denied that Maiden’s syrups were linked to the deaths in Gambia.
CEO Naresh Kumar Goyal assured Reuters in December that his company had done nothing improper, but he declined to answer any further questions for this article. A Maiden official in New Delhi also denied providing any further information.
The Gambia’s Medicines Control Agency also said that it had heard nothing from Maiden or Indian officials “despite our request for information after the discovery of the tainted products.”
WHO official Kuwana told Reuters that they are still investigating the situation with Maiden’s goods. According to notifications, the WHO is also investigating the supply chains of two other Indian drugmakers that manufactured tainted cough syrups exported to Uzbekistan and the Marshall Islands and Micronesia. Although three employees of one of the companies were arrested in India in March, both companies insist they did nothing wrong.
In January, Uzbek authorities detained four people in connection with the investigation. They did not immediately respond to calls for comment, and neither did Micronesian authorities.
Violations
There have been previous production problems with Maiden. An Indian court jailed the company’s Managing Director Goyal and Technical Director MK Sharma to two and a half years in prison in February for shipping fake pharmaceuticals to Vietnam over ten years ago.
They have a month to file an appeal, but Reuters has been unable to learn how far along that process is. Neither Goyal nor Sharma nor their attorney could be reached for comment. The Maiden representative was unwilling to elaborate.
A government document revealed that in October of last year, drug inspectors detected a dozen infractions at Maiden linked to the production of the cough syrups exported to Gambia. Some of the COAs for the raw materials used to make the syrups, such as propylene glycol, lacked batch numbers. Some products lacked production or expiration dates.
According to Reuters’ interviews with four professionals in the business and the regulatory body, this might suggest that there is no solid documentation of where the substances came from.
The PG used in the syrups was also untested, according to government inspectors. They claimed inconsistencies in batch manufacturing records and product labels, claiming that the syrup bottles’ labels claimed they were created in December 2021 but in fact the dates were in fact between February and March of 2022.
According to a former official in the Indian health ministry, this discrepancy would make it difficult for government testers to be sure the drugs they were analyzing were the same as those shipped to Gambia.
From 2014 to 2017, Kundan Lal Sharma oversaw medication and food regulation at the health ministry, and he claims that “there is complete discordance in the data in the labels and the batch records,” calling into question the authenticity of the product.
He concluded that this indicated that a plot had been hatched. Without the right paperwork, “no one can guarantee anything.”
Maiden has not answered to inquiries regarding the labeling or documentation, and the Indian health ministry has not said how it confirmed that the syrups tested by its labs originated from the same batches.
Kuwana stated that the WHO was confident in its own testing results showing contamination in the cough medication.
He claimed that the agency had not received the COAs for the raw ingredients or final goods that were sampled, despite repeated requests. He also claimed that the agency had not seen the entire results of the tests conducted on the syrups by the Indian government.
The agency has stated that, in light of recent developments, it is currently revisiting its rules on how countries should control raw ingredients in medications.
When asked how it was possible that the results of tests conducted by the WHO and India did not match, Kuwana responded that in previous cases of contaminated pharmaceuticals, a producer changed samples for testing that did not represent what was on the market. He stated the WHO was in the dark about whether or not that occurred.
It’s usually because we haven’t evaluated the same sample, Kuwana explained.
