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India’s Health Ministry has launched an “urgent investigation” after the World Health Organization (WHO) issued a medical product alert for four contaminated medicines identified in Gambia that have been “potentially linked with acute kidney injuries and 66 deaths among children”.
The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited in India, preliminary investigations show.
Health Ministry officials told businessline, the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, MoHFW — the National Regulatory Authority in the country — has taken up the matter with the State Regulatory Authorities “immediately after receiving communication from WHO”.
WHO has also been requested “to share at the earliest with CDSCO” the report on the establishment of causal relation to death with the medical products in question, photographs of labels/products, etc. That report is awaited.
Contamination confirmed
Ministry sources said, WHO on September 29 had informed DCGI, the National Drug Regulator of India, that it is currently providing technical assistance and advice to Gambia, where children have been suspected to have died reportedly due to the use of medicines that may have been contaminated with diethylene glycol or ethylene glycol. The contamination has been confirmed in some of the samples by further analysis conducted by WHO.
Post this, the CDSCO launched a detailed investigation “to ascertain the facts/ details in the matter” in collaboration with the State Drugs Controller, Haryana — the concerned State Drug Control Authority.
Licensed manufacturer
From the preliminary enquiry, it was found that Maiden Pharmaceutical Limited of Sonepat in Haryana is a manufacturer licensed by the State Drug Controller for the products. The company has made and exported these products only to Gambia so far.
“It is a practice that the importing country tests these products on quality parameters, and satisfies itself as to the quality of the products before their release for usage in the country,” the Ministry source said, adding that as per the tentative results received by WHO, out of the 23 samples tested, four have been found to contain diethylene glycol/ethylene glycol as indicated.
The Ministry was also informed that “the certificate of analysis will be made available to WHO in near future” and WHO will share it with India.
“At the same time, the exact one-to-one causal relation of death has not yet been provided by WHO, nor have the details of Labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products,” the source added.
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