Uzbekistan says 18 children died due to cough syrup made by Indian firm Marion Biotech

The Uzbekistan health ministry on Tuesday said that 18 children in the country have died because of side effects of a cough syrup produced by an Indian pharmaceutical firm.

In a statement, the health ministry said the children who died had consumed the Dok 1 Max Syrup produced by Noida-based Marion Biotech Limited. Dok 1 Max Syrup and tablets are anti-cold medication.

“Since the main component of the drug is paracetamol, Dok 1 Max Syrup was incorrectly used by parents as an anti-cold remedy on their own or on the recommendation of pharmacy sellers,” the statement said. “And this was the reason for the deterioration of the condition of patients.”

Preliminary investigation showed the cough syrup contains ethylene glycol, which is a toxic substance, the statement added.

Syrups are ideally not supposed to contain even traces of ethylene glycol, which is found in industrial grade of glycerine that is not permitted for medicinal purposes. For medical use, Glycerine IP, or Indian Pharmacopoeia, grade must be used in the making of a syrup.

Ethylene glycol and diethylene glycol can cause vomiting, convulsions, affect the circulatory system and cause acute renal failure.

Drug Controller General of India VG Somani, spokesperson for India’s health ministry and Marion Biotech did not respond to phone calls from Scroll.in. This article will be updated if they respond.

In its statement, the Uzbekistan health ministry said that the children who died, took 2.5 millilitres to 5 milliliters of the cough syrup at home for three to four times a day, which was higher than the standard dose of the drug.

After the deaths, tablets and cough syrups of Dok 1 have been withdrawn from sale in all pharmacies of the country, the statement said.

Seven employees have been dismissed for not analysing child mortality in a timely manner and failing to take necessary measures. A number of specialists are also facing disciplinary action.

Marion Biotech also exports drugs to United Kingdom, Georgia, Nigeria, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Azerbaijan, Kenya, Ethiopia, Sri Lanka, Myanmar, Laos and Vietnam.

The Gambia deaths and Indian manufacturing

The development in Uzbekistan came two months after the World Health Organization in October issued a global alert for four cough syrups made by Haryana-based Maiden pharmaceuticals.

The move came after authorities in The Gambia linked 66 deaths, most of them due to acute kidney failure, to the cough syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.

However, the Drugs Controller General of India on December 13 wrote to the global health body, saying that it had drawn a premature link between the deaths of the children and the cough syrups. The authority said that samples of the syrups were tested in a government laboratory and found to be complying with specifications.

Last week, a parliamentary report submitted by The Gambia’s government confirmed that Maiden’s syrups were linked with acute kidney failure in children.

“Efforts have been made in contacting the Maiden Pharmaceuticals Limited company in India, but they have not been answering to their emails and calls,” the committee report said.

The report added that the committee collected 10 syrups, and four were found contaminated. These were Makoff Baby, Kofexmalin, MaGrip Cold, Paracetamol Syrup and Promethazine Syrup.

Nepal’s Department of Drug Administration has also barred imports of medicines manufactured by 16 Indian companies. The authority said that the firms did not adhere to the World Health Organization’s good manufacturing practices.

The World Health Organization’s good manufacturing practice system is aimed at ensuring that products are “consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation”.