Haryana minister Anil Vij says Maiden Pharmaceuticals asked to shut production of cough syrups after WHO alert

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The Haryana government has shut down the production of cough syrups in Sonipat-based company Maiden Pharmaceuticals Limited’s plants.

The action was taken days after the World Health Organisation (WHO) flagged the deaths of over 60 children in Africa’s The Gambia allegedly after drinking the syrup made by the company.

Health Minister Anil Vij said the samples of the three syrups have been sent for chemical analysis at the Central Drug Laboratory in Kolkata. He said the central and state governments found 12 grave violations in the company’s manufacturing units after which they have been asked to halt production of the drugs. Notices have been sent to the company regarding this.

The pharma company had come under scanner following the death of 66 children who had allegedly consumed the cough syrup in The Gambia.

The World Health Organization (WHO) issued a medical product alert over four India-made cough and cold syrups manufactured by Maiden Pharmaceuticals on October 5.

“This WHO Medical Product Alert refers to four substandard products, identified in The Gambia and reported to WHO in September 2022. Substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore “out of specification,” the WHO said.

The four cough syrups linked to the deaths in The Gambia are — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.

The company was issued a show cause notice on October 7 after a joint inspection with the Central Drugs Standard Control Organisation. The pharma company has to reply to the notice by October 14, failing which action may be taken against it.

In an official statement the company`s Director, Vivek Goyal said, “We are in the field of medicines for over three decades and have been diligently following the protocols of the health authorities including Drugs Controller General (India) and the State Drugs Controllers, Haryana.”

He further said that they have valid drug approvals for the export of the products and his company is not selling anything in the domestic market. He also added that his company is obtaining raw materials from certified and reputed companies.

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