Will ensure Sonepat firm's drugs are off shelves in other nations too: World Health Organisation

Tribune News Service

Bhartesh Singh Thakur

Chandigarh, October 9

The World Health Organisation (WHO) has said the contaminated cough syrups produced by Sonepat-based Maiden Pharmaceuticals Ltd have been taken off shelves in Gambia and it has asked other countries to follow suit.

“The quality of medical products is non-negotiable,” said a WHO spokesperson, in response to an email from The Tribune. “The WHO is working to ensure that any remaining contaminated medicines are taken off shelves in Gambia and any other country importing these before any further harm is caused.”

Quality non-negotiable

The WHO is working to ensure any remaining contaminated drugs be removed from circulation in Gambia or any other country without delay. Spokesperson, WHO

Report awaited

We are awaiting the lab tests of the drugs in question. Anil Vij, Health Minister

On October 5, the WHO flagged four medicines — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — suspected to be behind the death of 66 children in Gambia. Maiden Pharmaceuticals had produced 10,000 bottles each of these syrups.

The Central Drugs Standard Control Organisation (CDSCO) and the Food and Drug Administration (FDA), Haryana, have maintained the WHO is yet to share laboratory report related to these drugs. Also, the report of tests conducted by the Central and state drug authorities is still awaited.

The WHO spokesperson claimed, “These products, which have been tested in two separate and authorised laboratories, have been found containing unacceptable levels of diethylene glycol and ethylene glycol. The WHO has issued alert so that other nations can identify the drugs in question and take immediate action.” Propylene Glycol is used as a solvent in pharmaceutical drugs like syrups, injectables and even topical formulations. If contaminated with diethylene glycol and ethylene glycol, the syrups can cause abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, leading to the death of patients.

“The WHO, at the global, national and regional levels, is collaborating closely with the Gambian government as well as with the Indian regulatory authorities to ensure these unsafe products are removed from circulation without further delay,” said the spokesperson. Meanwhile, Kerala has banned the sale of all drugs manufactured by Maiden Pharmaceuticals. Also, the FDA, Haryana, has issued a show-cause notice to the firm for gross contraventions related to propylene glycol, seeking explanation why its licence should not be suspended or cancelled.

“We are awaiting the lab tests of the drugs in question. However, following an inspection of the firm’s records by a joint team of the CDSCO and the FDA, a show-cause notice has been issued,” said Haryana Health Minister Anil Vij.

High contamination

• WHO claims Maiden Pharmaceuticals’ four cough syrups found containing high levels of diethylene glycol, ethylene glycol
• Such drugs can cause acute health issues, including kidney injury, leading to death of patient, say experts

Show-cause notice

• Food and Drug Administration, Haryana, issued show-cause notice to firm over drug contamination
• Health Minister Anil Vij said laboratory test results of the drugs in question awaited, won’t spare the guilty

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