By Athar Parvaiz

NEW DELHI

Following a WHO warning about possible toxic ingredients in four cough syrups of Indian origin, the Indonesian government has ordered a temporary ban on all liquid medicines in the country over reported spike in children’s deaths linked to medical syrups.

The 19 October ban by Indonesia came two weeks after the WHO’s global medical product alert, in response to the deaths of 69 children in Gambia, a country in West Africa, from acute kidney failure.

In a series of tweets, Indonesia’s health ministry said that as of 18 October, 206 children in 20 provinces were reported to have suffered acute kidney failure and that 99 of them had died. That number have risen to 133 this week and is still expected to rise as the health ministry continues with its investigations into unregistered medical syrups sold in the country.

SciDev.Net reached out to the health ministry of Indonesia and the head of the Indonesian Pediatrician Association but none of them responded to queries about the connection with the Indian drugs which are supposedly not sold locally.

A WHO official said the global health organization had “issued an alert about sub-standard/contaminated pediatric medicines – mainly cough syrups – produced by a company in India and sold in Gambia”.

According to the WHO, as of 6 October, 81 cases of acute kidney injury had been reported, including 69 fatal ones. WHO named the products as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, manufactured by Maiden Pharmaceuticals Limited, Haryana state, India. The contaminated products contained “unacceptable amounts” of ethylene glycol and diethylene glycol.

SciDev.Net tried to reach the officials of Maiden Pharmaceuticals to comment on the controversy involving their products but all calls made were repeatedly ignored.

“Every batch of medicine that is shipped out from a factory carries a certificate of analysis, a legal document that tells the buyer that the pharmaceutical company had tested the batch being shipped. If the pharma company makes misrepresentations on this document, it must be held liable”

Dinesh S Thakur, public health activist

On Wednesday, the Philippines’ Food and Drug Administration issued its own advisory against the four drug products although it clarified that they are not registered locally.

Asserting that the quality of medical products is non-negotiable, the WHO, in an email to SciDev.Net said, it was collaborating with the Gambian government as well as with Indian regulatory authorities that are pursuing investigation to ensure that unsafe products are removed from circulation. “The deaths of children, potentially linked to contaminated medicines, is a tragedy beyond words,” the WHO statement said.

Dinesh S Thakur, a public health activist and who co-authored a book about the failings of India’s drug regulation, said, that the deaths children in the Gambia is a glaring example of the inadequate functioning of India’s drug regulatory agencies. “This has happened time and time again because India has a dysfunctional drug regulatory system … and there is no accountability of the drug regulators to the people,” Thakur told ScidDev.Net.

Said Thakur: “Every batch of medicine that is shipped out from a factory carries a certificate of analysis, a legal document that tells the buyer that the pharmaceutical company had tested the batch being shipped. If the pharma company makes misrepresentations on this document, it must be held liable.”

Queries sent to the Drug Controller General of India’s office on 20 October were acknowledged but not responded to. An official told SciDev.Net: “An investigation has been initiated and I can’t speak till the investigation gets completed.”

On 29 September India’s health ministry issued a statement saying that preliminary investigations had revealed that the products mentioned by WHO were indeed manufactured by Maiden Pharmaceutical Limited, a company based in Haryana state that had exported these products exclusively to Gambia.

“It is a usual practice that the importing country tests these imported products on quality parameters, and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country,” the statement said.

“As per the tentative results received by WHO, out of the 23 samples of the products under reference which were tested, 4 samples have been found to contain Diethylene Glycol/ Ethylene Glycol. It has also been informed by WHO that the certificate of analysis will be made available to WHO in near future and WHO will share it with the Indian Regulator which is yet to be done,” the government statement said. “The exact one-to-one causal relation of death has not yet been provided by WHO to CDSCO (Central Drugs Standard Control Organization).”

According to an article published by the National Library of Medicine of the US government, diethylene glycol is a toxic alcohol used in brake fluid, paint, and household cleaning products, and has been used illegally as a cheap substitute solvent in drug manufacturing.

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Courtesy: Sci. Dev. Net (Published on October 28, 2022) 

The post Indonesia bans cough syrups first appeared on Sindh Courier.

From Our Correspondent

KHAIRPUR

Shortage of the Corex-D Cough Syrup has been reported in the markets of Khairpur and Sukkur, and one of the main reasons is said to be its consumption as alcoholic drink by the addict population being easily available.

Such drugs are sold without check as generally the owners of the Medical Stores sell the medicines without the prescription of the qualified doctors.

It has been observed here that the people frequently use the Corex-D syrup in parties and other gatherings because it’s a cheapest drink than the other alcoholic drinks.

Meanwhile, eminent Physician Dr. Abdul Hayee Phulpoto said that 60 percent population of the Sukkur and Khairpur used self-medication, while the Medical Store Keepers do not demand from the people any prescription suggested by the doctors. “They are doing business without any fear of law providing harmful drugs like Corex-D syrups as well as injunctions like Diazepam and other tablets used as tranquilizer which are making the people drug addict,” he told.

He said that there exists a Health Care Commissions setup by the health department of Sindh government to keep check and prevent the Pharmacy houses from the sale of banned drugs and to verify the Licenses. “But the Drug Inspectors posted in the districts to keep check, never bother to perform duties. There was a no such practice witnessed, and that was a main reason that drug addicts’ number was increasing,” he remarked.

Dr. Phulpoto said that many deaths happened due to use of the alcoholic drugs being used without the prescription of the doctors.

He suggested to impose ban on selling all kinds of medicines without the prescription by the doctors and Health Care Commission should ensure the strict action against the unlicensed pharmacies and practice of the quacks to save the precious lives of the citizens.

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The post Youth consuming Corex-D Cough Syrup as alcoholic drink first appeared on Sindh Courier.