New Delhi: Maiden Pharmaceuticals Limited, the Sonepat-based medical firm has been found to have committed multiple violations. The Indian pharma company is currently under scanner for four “substandard” and “contaminated” cough syrups potentially linked to the deaths of 66 children in the Gambia. As per reports, the company did not perform quality testing of a raw material used in the manufacture of one of the medicines, read a notice sent after an official inspection.Also Read – Haryana Stops Production of 'Contaminated' Cough Syrups by Maiden Pharmaceuticals
A preliminary report stated that it has been found that the company has not done quality testing of propylene glycol for diethylene glycol and ethylene glycol. Also Read – 4 Indian Cough Syrups Banned by WHO Contain This Toxic Chemical. Here's Why Is It Dangerous
Earlier this week, Maiden Pharmaceuticals had expressed shock over the media reports regarding the deaths of 66 children in the Gambia after consuming cough syrup manufactured by them. 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.
The drug regulators have collected the samples of cold and cough syrup from the manufacturing facility of Haryana-based Maiden Pharmaceutical in Sonipat, after WHO issued a medical alert and results are expected to come soon.
“The samples have been drawn by the CDSCO officials and we are awaiting the results and since the matter is already pending investigation and subjudice, we cannot comment on any other issues and shall update you in future as and when we receive the information,” he added.
WHO on Wednesday issued an alert over four India-made cough and cold syrups which are made by Maiden Pharmaceuticals in India. WHO has also notified that the same cough and cold syrups could be linked to the deaths of 66 children in Gambia.
As per sources, from the preliminary enquiry, 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.