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"I have never changed the sample," Maiden founder Naresh Kumar Goyal told Reuters. "There is no evidence and no proof against us. I have not given a bribe."
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While the World Health Organization (WHO) linked the syrups made by India's Maiden Pharmaceuticals to the deaths of 70 children in the African country last year, India's government says tests at an Indian government laboratory showed the syrups were not toxic.
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In September last year, three cough syrups supplied by Maiden Pharmaceuticals were linked to the deaths of nearly 80 children in Gambia, but later the Indian government said that in-country examination had found no contamination in the drugs supplied to the African nation.
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On December 27, Uzbekistan had said that 18 children may have died after consuming contaminated DOK-1 Max syrup by Marion Biotech. WHO issued a medical product alert for two substandard cough syrups by the Uttar Pradesh-based drug maker on February 12
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Experts point out that laxity on the part of regulators has resulted in substandard and adulterated drugs hitting markets in India and other countries with weak regulatory oversight.
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The move comes nearly a month after a detailed inspection at the drug manufacturing unit of Maiden Pharmaceuticals in Haryana found several Good Manufacturing Practices violations
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The plant was closed after the World Health Organization said in October that its investigators had found "unacceptable" levels of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury, in the products.
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Maiden Pharmaceuticals welcomed the government test lab reports and said that the drugs produced by the company weren’t adulterated.
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Officially, the government has maintained that there is nothing wrong with the drug-quality monitoring regime. But the move to set up a panel to create a repository of medicines licensed and marketed in India is being seen as an admission of loopholes in the system.
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A rigorous investigation needs to be conducted into the affairs of the Indian drug regulators
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Experts say that the detection of contaminants diethylene glycol and ethylene glycol in the India-made cough syrups by the WHO and Indian authorities themselves is strong enough evidence against the poor and unsafe quality of the cough syrups. 66 children are reported to have died in The Gambia after consuming the syrups.
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The authorities are trying to ensure that the ingredients used to make cough syrups conform to standards and are safe for consumption.
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In a five-page note accessed by Moneycontrol, Haryana drugs officials have listed out 12 contraventions which were detected during an inspection of the manufacturing facility in Sonepat.
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Trouble for the Haryana-based drugmaker, which is in soup for allegedly exporting adulterated cough syrups, may escalate as initial investigations by Indian authorities have found major violations on its part
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The recent incident of medicines from India purportedly leading to the death of 66 children in Gambia has once again brought the spotlight on loopholes with drug quality monitoring in the country
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Four cough syrups sold by the company in The Gambia have been blamed for the death of 66 children.
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The company will only be allowed to sell drugs again if the government authorities get satisfactory results after running quality checks on the available stock of medicines, Kerala state drug controller PM Jayan has told Moneycontrol
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All production activities at the factory have been stopped; staff have been told not to attend work till clarity emerges on the issue.
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The World Health Organisation (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.
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Haryana-based Maiden pharmaceuticals is in the eye of a storm for supplying adulterated cough syrups to Gambia. It has now emerged that the firm has been a habitual offender.
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At least three Indian states and one country had acted against Maiden Pharma for producing substandard products
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The ministry said in a statement that the cough syrups made by local manufacturer Maiden Pharmaceutical has permission to manufacture these products for export only.
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"Samples have been sent to a central pharmaceutical laboratory for testing," Anil Vij, the health minister of Haryana state where Maiden has its factories, told reporters. "Strict action will be taken if anything is found wrong."
