'We're not selling anything in domestic market. We've been obtaining raw materials from certified & reputed companies,' said Maiden Pharmaceuticals Ltd, the Haryana-based company that recently came under fire for DEG contamination in their cough syrups that allegedly caused the death of 66 children in the Gambia.
According to a statement put out by the company, the Central Drugs Standard Control Organisation (CDSCO) officials have taken samples (of the cough syrups in question) and they are awaiting the results, reported news agency ANI.
What Happened in the Gambia?
The World Health Organization (WHO) on Wednesday, 5 October, issued a warning alert against four cough and cold syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — manufactured by Indian pharmaceutical company, Maiden Pharmaceuticals, after 66 kids died in the Gambia over the last few months.
According to WHO the cough syrups have been linked to the deaths of the children who had developed acute kidney as a result of (Diethylene glycol) DEG poisoning.
All the four cough syrups were found to have unsafe levels of diethylene glycol and ethylene glycol. These chemicals are typically used as brakefluid, and lubricants for heavy machinery, and they are extremely harmful if ingested.
The WHO has said that they will be conducting an investigation, adding that 'to date, the stated manufacturer (Maiden Pharmaceuticals), has not provided guarantees to WHO on the safety and quality of these products.'
The incident in Gambia is not the first of it's kind. at least 5 episodes of children dying from DEG poisoning linked to contaminated medicines have been reported in India alone - the latest incident involving the death of 11 children in Jammu in 2020.
Maiden Pharmaceutical's Track Record
In the statement released by Maiden Pharmaceuticals, they say that they have been 'diligently following the protocols of health authorities, including the CDSCO, and the state drugs' controller of Haryana'.
The company's website says that they are a WHO-GMP & ISO 9001-2015 certified pharmaceutical company.
The WHO-GMP Certified Manufacturing Units for Certificate of Pharmaceutical Products (CoPP) list published by the CDSCO clearly has Maiden Pharmaceuticals on it.
The CoPP (Certificate of Pharmaceutical Product) is a stamp of assurance given by the central authority to buyers overseas that it has inspected and ensured that the exporting pharma company complies with WHO cGMP standards.
Despite these certification, the company has, on several occasions, been pulled up by various health authorities for their medicines allegedly not meeting safety standards.
In a Twitter thread, Public Health Activist Dinesh Thakur outlines the company's various run-ins with health authorities in the past.
According to Thakur, the company was prosecuted by a government health inspector for quality violations under the Drugs & Cosmetics Act, in 2018.
Before that, in 2017, BTW, a Magistrate Court in Kerala prosecuted the company fined this company Rs 1000 under the same Act.
The company was blacklisted by Bihar (2011) and Jammu and Kashmir (2019) for supplying sub-standard drugs.
The company was also blacklisted by Vietnam in 2014 for violation of Quality Control Regulation and Drug Regulation.
Since the incident, in press release, the Drugs Controller's Office has suggested that the approval for the drug manufacturing falls under the jurisdiction of the Haryana State Regulatory Authority.
CDSCO has also requested the WHO to share with it, the report linking the deaths in Gambia to the cough syrups, and assured that an investigation has been launched by them in collaboration with the Haryana state regulators.
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