The WHO warned that four 'contaminated' and 'substandard' cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation.
The Indian government has started a probe into the manufacturing of cough syrup by a Haryana-based pharmaceutical firm after the World Health Organisation (WHO) warned that they could be linked to the deaths of 66 children in The Gambia, West Africa.
The WHO on Wednesday warned that four "contaminated" and "substandard" cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation.
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
According to reports, WHO had alerted the Drugs Controller General of India (DCGI) on September 29 about the potentially harmful effects of the medicine, following which DCGI took up the matter with the Haryana regulatory authority and launched a detailed investigation, the health ministry said.
WHO Director-General Tedros Adhanom Ghebreyesus said, "The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited in India. WHO is conducting further investigation with the company and regulatory authorities in India." Further, he added that the loss of young lives due to the products is "beyond heart-breaking for their families".
The manufacturer of these products “to date, has not provided guarantees to WHO on the safety and quality of these products”, it added.
The WHO has warned that the syrups may have been distributed outside the West African country and global exposure is "possible".
The health regulatory body further said that the syrup has been "potentially linked" with acute kidney injuries and 66 deaths among children in The Gambia.
The WHO has not yet provided details on when these deaths took place.
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The four cough syrups were found to have unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
WHO said that Diethylene Glycol (DEG) or ethylene glycol is toxic to humans when consumed and can prove fatal. The contents are known to cause kidney and neurological toxicity and have been associated with several cases of mass poisoning when consumed via drugs.
The chemical is also used to make brake fluids, cosmetics, and lubricants and consumption can also cause renal failure leading to death and coma.
The toxic effect of the chemicals, which taste sweet and is water-soluble, include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury.
The sources from the government said the exact "one-to-one causal relation of death" has neither been provided by the United Nations Health Agency nor the details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.
The WHO has not yet provided details on when these deaths took place.
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"The company has manufactured and exported these products only to The Gambia so far," the source said. It is a practice that the importing country tests the products for quality before sanctioning their usage there.
Samples of the four cough syrups, sources said, will now be tested in central and regional laboratories and results will come in within two days. The sources said that as per protocol, any drug exported from India is tested by the recipient country. The question is why was the contamination not detected during testing in The Gambia, the sources said. They also said that the WHO has not informed whether the drugs were used in the west African country without testing.
The Centre said none of the four is sold in India. In a press release, the Union Health Ministry said, "The State Drug Controller had given licenses to the said Company only for export of these four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. Further all these 04 drugs manufactured only for exports by M/s. Maiden Pharmaceuticals Limited are not licensed for manufacture and sale in India. In effect, none of these four drugs of M/s. Maiden Pharmaceuticals is sold domestically in India."
Haryana Health Minister Anil Vij said samples of four cough syrups manufactured by the firm have been sent to the Central Drugs Laboratory in Kolkata for examination. The minister too said the cough syrups manufactured by Maiden Pharmaceuticals were approved for export. "It is not available for sale or marketing in the country."