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A team of drug inspectors from the Centre and Uttar Pradesh government visited the Noida manufacturing facility of a company whose cough syrup Uzbekistan said caused the deaths of 18 children in the Central Asian country.
Union Health Minister Mansukh Mandaviya said on Twitter that the Central Drug Standard Control Organisation (CDSCO) has been in contact with Uzbekistan’s drug regulator since December 27 concerning “contaminated” cough syrups made by Noida-based Marion Biotech.
“Immediately on receipt of the information, a joint inspection of Marion Biotech’s Noida facility was carried out by UP Drug Control and the CDSCO team. Further action as appropriate would be initiated based on the inspection report,” Mandaviya said, adding that the samples of the cough syrup have been sent to Regional Drugs Testing Laboratory in Chandigarh.
The Health Ministry said that there have been reports from Uzbekistan concerning contaminated cough syrup Dok1 Max made by Marion Biotech.
A World Health Organization (WHO) spokesperson told ‘Business Standard’ that the agency is “in contact with health authorities in Uzbekistan and is ready to assist in further investigations.”
According to news agency ANI, Marion Biotech has halted production of the cough syrup under the scanner. “We regret the deaths. The government is conducting an enquiry. We’ll take action as per the report,” Hasan Harris, a legal representative of Marion Biotech, told the agency.
Uzbekistan’s Health Ministry has said that samples of Dok-1 Max Syrup, produced by Marion Biotech, contained Ethylene Glycol. Dok-1 Max Syrup and tablets are used as anti-cold medication.
Ethylene Glycol is toxic if found in medicines. This chemical is found in industrial-grade glycerine, and is not permitted for medicinal purposes. Consuming ethylene glycol can lead to convulsions, renal failure; affect the circulatory system, vomiting etc.
Marion Biotech holds a licence for manufacturing of Dok1 Max Syrup and tablets for exports allowed by Uttar Pradesh’s drugs controller.
Uzbekistan’s allegation comes within months of a controversy in Gambia where the WHO said that cough syrups manufactured by Haryana-based Maiden Pharmaceuticals were contaminated, leading to the deaths of 70 children.
Indian regulators stopped production at Maiden Pharma’s Sonipat site and collected samples. Earlier this month, the Drugs Controller General of India (DCGI) said that the samples were found not to be contaminated and wrote a strongly letter to the WHO saying that the international agency drew a “premature” link for the deaths.
The WHO stood by its action and said that its contracted laboratories in Ghana and Switzerland tested the suspected cough syrups products from Gambia and confirmed excess levels of ethyleneglycol and diethylene glycol.
Maiden Pharma’s plant is yet to resume operations as it was found to be in non-compliance with good manufacturing practices (GMP) by the Indian drug regulator.
The CDSCO has started conducting inspections of identified drug manufacturing units jointly with state authorities across India. The idea of the joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country, said Health Ministry on Tuesday.
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