The World Health Organization (WHO), which recently issued a medical health warning against cough syrups manufactured by the Indian company Maiden Pharmaceuticals following the deaths of 66 children in The Gambia, informed the Drug Controller General of India (DGCI) on October 29 that it 23 samples of drug references for further investigation and four samples were found to be contaminated with diethylene glycol/ethylene glycol – an ingredient that may have contributed to the deaths of the children.
New Delhi,UPDATED: 13 Oct 2022 00:25 IST
The WHO warned that the four lower-quality products contain diethylene glycol/ethylene glycol which is toxic and potentially fatal. (Representative image)
By Sneha Mordanic: The World Health Organization (WHO), which recently issued a medical health warning against cough syrups manufactured by the Indian company Maiden Pharmaceuticals after the deaths of 66 children in The Gambia, informed the Drug Controller General of India (DGCI) on October 29 that the technical provide assistance and advice to The Gambia.
The WHO also said it had collected 23 samples of the drugs under investigation for further testing and that four samples were contaminated with diethylene glycol/ethylene glycol, an ingredient that may have contributed to the deaths of the children.
Here’s What Happened After WHO Notified India’s Drug Controller General About the Death of the Gambia’s Children
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The CDSCO immediately took the matter up with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of M/s Maiden Pharmaceutical Limited, Sonepat, is located. The CDSCO launched a detailed investigation to establish the facts/details in the case in conjunction with State Drugs Controller, Haryana.
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CDSCO’s preliminary investigation has revealed that M/s Maiden Pharmaceutical Limited, Sonepat, Haryana is a manufacturer under license from the State Drug Controller of the products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup under reference, and is authorized to manufacture these products for export only. The company has only manufactured and exported these products to The Gambia.
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It is common practice for the importing country to test such imported drugs for quality parameters and satisfy itself with the quality of the products before the importing country decides to release such products for use in the country. In the present case, it is not yet clear whether these medicines were tested in The Gambia before they were put on the market.
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The WHO informed that according to the preliminary results it received, of the 23 samples of the products under investigation that were tested, four samples contained diethylene glycol/ethylene glycol. The WHO has not yet made a Certificate of Analysis available and has indicated that such a certificate will be available in the near future.
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The exact one-to-one causation of death has not yet been provided by WHO to CDSCO, despite the latter requesting WHO twice in this regard.
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The State Drug Controller had only licensed the said company to export four drugs, namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. All four drugs manufactured for export only by M/s. Maiden Pharmaceuticals Limited is not licensed for manufacture and sale in India. In fact, none of these four drugs are from M/s. Maiden Pharmaceuticals is sold in India.
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The samples (controlled samples of the same batch manufactured by M/s. Maiden Pharmaceuticals Limited for all four drugs in question) have been taken and sent for testing to the Regional Drug Testing Lab, Chandigarh and the results are awaited.
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The CDSCO and the state drug controller Haryana have stopped all production activities of M/s. Maiden Pharmaceuticals Limited in Sonepat on October 11 due to deficiencies identified during local inspection.
Meanwhile, a committee of technical experts has been formed which, after reviewing and analyzing the adverse event reports, causality and all related details shared by WHO, will properly advise and recommend the DCGI on further steps. The Committee may co-opt any other technical expert if deemed necessary.
Dr.YK Gupta, Vice-Chairman of the Standing National Committee on Medicines (Chairman), Dr.Pragya D Yadav, of the National Institute of Virology, Pune, Dr. Arti Bahl of the Department of Epidemiology, National Center for Disease Control (NCDC ), New Delhi and AK Pradhan, JDC(I), of the Central Drugs Standard Control Organization (CDSCO) are the technical experts included in the committee.
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