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Acting on the WHO Medical Product Alert that was issued for four "contaminated" medicines, India has launched a detailed investigation to ascertain the facts/ details in the matter. The cough and cold syrups manufactured by Sonepat-based Maiden Pharmaceuticals have been allegedly linked to the deaths of dozens of children in the west African nation of The Gambia.
According to the WHO alert issued on Wednesday, samples of the medicines exported to Gambia have been found to contain toxic chemicals such as diethylene glycol and ethylene glycol.
Now, a team of the Central Drugs Standard Control Organisation (CDSCO), the Drug Controller General of India (DCGI) and Haryana State Drugs Controller have collected the samples of the four medicines (from the same batch of the drugs in question) for investigation.
The samples have been sent for testing to Regional Drug Testing Lab, Chandigarh. The results will guide further course of action as well as bring clarity on the inputs received/ to be received from WHO, the Ministry of Health and Family Welfare said in a press note.
The products in question are Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. Preliminary enquiry of CDSCO has found that the Maiden Pharmaceutical Limited holds manufacturing permission for these products for export only and it has exported these products only to Gambia, the press note stated.
These drugs are not licensed for manufacture and sale in India. Hence, none of these four drugs is sold domestically in India, the Health Ministry added.
The ministry pointed out it is a usual practice for the importing country to test such imported medical products on quality parameters before releasing them for usage in the country.
It added, "As per the tentative results received by WHO, out of the 23 samples of the products under reference which were tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol."
The WHO has informed DCGI that it will share the certificate of analysis with the Indian Regulator when it is made available to the organization, which is yet to be done.
CDSCO has also requested WHO to share at the earliest the report on establishment of causal relation to death with the medical products in question.
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