69 Gambian Child Deaths: Indian Govt Halts Production of ‘Contaminated’ Cough Syrups by Maiden Pharmaceuticals Over 12 Violations Of Good Practices

Sonepat: Maiden Pharmaceuticals Limited factory in Sonepat district, Thursday, Oct. 6, 2022. A probe has been initiated by India's drug regulator after WHO issued an alert saying cough syrups manufactured by the Indian firm could potentially be linked to the death of children in Gambia. (PTI Photo)(PTI10_06_2022_000103B)

  • Haryana Health Minister, Anil Vij inspected a Maiden factory in the town of Sonepat in the state and found 12 violations of good practices. Production was ordered stopped, Vij said
  • Earlier on Monday, the Indian Pharma company had released a statement over the reports linking its cough syrups to the deaths of 66 children in Gambia

ew Delhi: Haryana government stopped the production of cough syrups by Maiden Pharmaceuticals Ltd after the WHO issued an alert over four India-made cough and cold syrups which are made by the pharmaceutical company and notified that the deaths of 69 children in Gambia could be linked to the cough and cold syrups.

The Haryana Home and Health Minister Anil Vij also said, “After the Central & Haryana State drug depts conducted a joint inspection, around 12 flaws were found, keeping which in mind, it’s been decided that the total production shall be stopped; notice given.”

A WHO Medical Product Alert had last week said that the four substandard products, reported to it in September, are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, all manufactured by the Maiden medical firm.

The information from WHO that cough syrups manufactured by an Indian pharma company caused the death of 66 children due to the presence of ethylene glycol is alarming. A probe has been initiated by India’s drug regulator after the WHO alert.

Earlier on Monday, the Indian Pharma company had released a statement over the reports linking its cough syrups to the deaths of 66 children in Gambia.

In an exclusive input to ANI, the pharma company said, “We are shocked to hear the media reports regarding the deaths and deeply saddened on this incident but we received the official information from our agent at the Gambia on October 5, 2022, and on the subsequent date, World Health Organisation alert was issued against us.”

In an official statement the company 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,” reads the statement.

He further said that they have valid drug approvals for the export of the products 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.

“The government agencies visited our factory on October 1 and October 3, October 6 and 7 October and the samples were drawn by the Central Drugs Standard Control Organisation(CDSCO) along with all relevant documents in question in presence of our directors,” Goyal said in the statement.

As per sources, from the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited, Sonipat, Haryana is a manufacturer licensed by the State Drug Controller for the products under reference, and holds manufacturing permission for these products.

The company has manufactured and exported these products only to the Gambia so far.

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