Indian Cough Syrups Killed More Than 70 Children In Gambia – WHO Alert

(CTN News) – According to a chemicals merchant participating in the supply chain, an unnamed intermediary in Mumbai delivered a critical raw material used in Indian cough syrups that were related to the deaths of more than 70 children in the Gambia.

Indian Cough Syrups Produced By

The syrups, produced by the Indian company Maiden Pharmaceuticals Ltd., were found to contain the deadly poisons ethylene glycol (EG) and diethylene glycol (DEG), which are also found in brake fluid.

Because they can cost less than half as much, these ingredients can be used by dishonest actors as a substitute for propylene glycol (PG), a crucial base of syrupy medicines, according to a March report from Reuters.

Most of the dead kids were under five years old and suffered from severe kidney injury; some of them passed away just days after taking the syrups.

The propylene glycol used in the syrups came from Goel Pharma Chem, a pharma-supplies company with headquarters in Delhi.

And was “recorded to have been imported” from South Korean producer SKC Co Ltd (011790.KS), according to information sent to the WHO by India’s medicines regulator in December.

Sharad Goel, whose north Delhi-based company bears his name, claimed to have purchased the material in sealed barrels, though not from SKC.

For the first time, Goel spoke up to Reuters in February.

Goel stated, “I can’t name the supplier – we have business links that we need to keep,” adding that his business had “not done anything wrong.”

He said that his company was “just a trader, passing on sealed barrels that we receive.” We have no control over them.

Reuters was unable to independently corroborate Goel’s claim.

He claimed that his business had ceased selling PG following the poisonings in the Gambia but had continued to supply other goods, such flour, and that he typically purchases the majority of his goods from 8–10 importers.

After that, Goel stopped returning phone calls, and when a reporter called twice in April, his office was shut. Workers at a nearby facility reported that they had not seen it open in the recent months.

SKC Told That it had Never Supplied any PG either to Goel or to Maiden

If correct, Goel’s assertion would identify a gap in the investigations into the contaminated products conducted by the WHO, India, and the Gambia.

The WHO and the Gambia’s government claim that the paucity of information coming from India has hindered their efforts to identify the perpetrator.

According to a letter it gave to Maiden that was obtained by Reuters, India’s pharmaceuticals regulator stated in December that its own tests had revealed no contaminants in the syrups.

But factory inspectors had earlier discovered that some batches of medication may have been mislabeled.

In light of that, it has not made it apparent how it can be certain that it tested the right batch.

Inquiries about the purported intermediary or any other issues brought up in this narrative were not answered by India’s health ministry.

The WHO’s main investigator indicated that enquiries have come to a “dead end” due to a lack of information from the Indian authorities and the manufacturer when questioned about the allegation that there was a middleman in the supply chain.

“If you ask and you don’t get informed, it’s a dead end,” said Rutendo Kuwana, the WHO’s team head for events involving substandard and counterfeit medications, in an interview with Reuters on March 31.

This week, a WHO representative stated that the only information the organisation has so far from Indian authorities is that Goel purchased propylene glycol from SKC.

However, no documentation of the transactions was given. The WHO claimed that it had likewise been unsuccessful in getting the Korean authority to validate that transaction.

An inquiry for comments was not answered by the Korean regulatory body.

The Indian regulatory body claimed that it obtained its knowledge of the raw materials from certificates of analysis (COAs), which are the common documents used to trace each component in a drug supply chain.

Maiden said purchased raw ingredients from “certified and reputable companies.”

India’s health ministry has informed the WHO that the charges against Maiden’s syrups “adversely impacted the image” of the $41 billion pharmaceutical sector in the nation and that it does not accept responsibility for the deaths in Gambia.

Naresh Kumar Goyal, the CEO of Maiden, told Reuters in December that his company had done nothing illegal and declined to comment more for this article.

Also declining to comment was a Maiden representative in the company’s New Delhi headquarters.

The Gambia’s Medicines Control Agency added that despite its request for information following the discovery of the contaminated items, neither Maiden nor the Indian authorities had responded.

Kuwana of the WHO told Reuters that his organisation is still determined to learn what transpired with Maiden’s products.

According to notifications issued by the organisation, the WHO is also attempting to learn more about the supply chains of two further Indian pharmaceutical companies that created tainted cough syrups that were distributed in Uzbekistan, the Marshall Islands, and Micronesia.

Both businesses deny wrongdoing; however, three employees of one of them were detained by Indian police in March.

In connection with that investigation, Uzbek authorities detained four individuals in January. Requests for comment from them and the Micronesian authorities received no immediate response.

Indian Cough Syrups Violation

Maiden has a history of having production problems.

Two of its executives—Managing Director Goyal and Technical Director M.K. Sharma—were given prison terms of two and a half years in February by an Indian court for the almost ten-year-old narcotics export to Vietnam.

The court gave them one month to file an appeal; Reuters was unable to learn the case’s status.

Requests for comment from Goyal went unanswered, and neither Sharma nor his lawyer could be reached. The spokesman for Maiden chose not to respond.

According to a government document, drug inspectors discovered 12 infractions at Maiden in October relating to the manufacturing of the cough syrups shipped to Gambia.

Propylene glycol COAs and other raw materials utilised in the syrup production, among others, lacked batch numbers. Some products lacked production and expiration dates.

This implies that there may not be a trustworthy record of where the materials came from, according to four industry and regulatory experts who spoke to Reuters.

Inspectors from the authorities discovered Maiden had neglected to examine the PG used in the syrups

The labels on the syrup bottles said they were created in December 2021, while batch manufacturing records indicated later dates, between February and March in 2022.

They identified inconsistencies in the paperwork of the finished products.

According to a former Indian health ministry official, this discrepancy would make it difficult for government testers to confirm that the medications they were evaluating were the same as those shipped to Gambia.

The information on the labels and the batch records are completely at odds, which raises concerns about the product’s authenticity, according to Kundan Lal Sharma, who oversaw medicine and food regulation for the Health Ministry from 2014 to 2017.

This indicates that something has been concocted, he said. Nobody can make a guarantee without the necessary paperwork.

In addition, Maiden has not responded to inquiries concerning the labelling or documentation, and India’s health ministry has neglected to explain how it determined that the syrups examined by its labs originated from the same batches.

The WHO’s own tests on cough syrup from two different independent laboratories, both of which revealed contamination, Kuwana claimed, were conclusive.

He said that despite repeated requests, the agency has not been given access to the complete results of the tests the Indian government conducted on the syrups or the certificates of analysis for the raw ingredients or final goods sampled.

Based on the recent events, the agency claims it is currently evaluating its recommendations for how nations should regulate the raw materials used to make medications.

When questioned about how it was possible for test findings from the WHO and India to differ, Kuwana responded that in previous cases of tainted medications.

A producer had swapped samples for testing that did not reflect what was available on the market. He claimed that the WHO was unaware of whether it had occurred in this instance.

Kuwana explained that typically when that occurs, it is because we haven’t tested the same sample.