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Fresh WHO alert on 'contaminated' Indian cough syrup

Nidhi Suresh
August 8, 2023

The UN's health body warned that the contaminated mixture could result in "serious injury or death." This is the fifth such warning against medicine produced by an Indian manufacturer.

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Medical employees packing drugs at the Serum Institute of India in Pune
It's the latest in a series of warnings against products made by India's major pharma sectorImage: Rafiq Maqboo/AP Photo/picture alliance

The World Health Organization (WHO) on Monday issued a global alert regarding an Indian-made cough syrup called "Cold Out," which is being sold in Iraq. The medication was found to be contaminated with toxins.

"The substandard batch of the product is unsafe and its use, especially in children, may result in serious injury or death," the alert warned.

This is the fifth such warning being issued against an Indian pharmaceutical manufacturer in the past 10 months.

Alert on toxins and its effects

The syrup was manufactured by Fourrts (India) Laboratories for Dabilife Pharma and it contained contaminants higher than the acceptable level, said the WHO.

However, Bala Surendran, the vice president of the company, told Bloomberg news last month that the production of the medicine had been subcontracted to another company and that his company had not found any toxins in a sample they had reviewed.

Cough syrup parents in India demand answers

The batch of syrup found on the Iraqi market had 0.25% of diethylene glycol and 2.1% of ethylene glycol. The acceptable safety limit for both is up to 0.10%, the WHO said.

The agency added that the manufacturer and marketer have not provided guarantees to the WHO on the safety and quality of the product.

The WHO listed the "toxic effects" of the syrup as "abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death."

The Ministry of Health in India announced that after the medicine failed separate tests conducted in Iraq, products were now being confiscated from the market, reported Bloomberg.

India faces series of medical alerts

Last year, cough syrups made by Maiden Pharmaceuticals in India were linked to the death of at least 89 children in Gambia and Uzbekistan.

Indian authorities also found toxins in a cough syrup made by Riemann Labs which were linked to deaths in children in Cameroon.

Families of the Gambian children hold candles
A cough syrup made in India was linked to the death of at least 89 children last year in Gambia and UzbekistanImage: Omar Wally/DW

In March, Marion Biotech, which exported syrups to Uzbekistan, lost its license and some of its employees were arrested after 18 children died from the product.

This year India mandated testing of cough syrups before exports to prevent such instances, reported the Indian Express.

This article was written in part with material from Reuters news agency.