New Delhi: The World Health Organization on Wednesday issued a product alert where it flagged at least four cough syrups made in India as “substandard”. The apex global health body interlinked the death of 66 children in the Gambia by acute kidney injuries to these very cough syrups.
These syrups were manufactured, as per the WHO Chief Tedros Adhanom Ghebreyesus, by Haryana-based Maiden Pharmaceuticals. In a note-issuing, this product alert, WHO said that there were excessive amounts of contaminants in these products.
“The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup , and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India).
To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” WHO said adding that they are conducting inquiries with the company and the regulatory authorities in India.
It added that drug analysis carried out by it has revealed the presence of “unacceptable amounts of diethylene glycol and ethylene glycol”. WHO said that these very chemicals have various toxic effects on the human body when consumed and they may even lead to the death of one consuming them.
“Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death,” it said adding that all the batches of these very medicines should be considered as unsafe till the time they are reviewed by the National Regulatory Authorities
The global health body said that while it has identified the presence of such syrups in the Gambia, there may be more supply into the other countries through informal market. It added that it was very imperative for authorities to identify and remove these substandard products. It stressed on the need of increased surveillance within the supply chains in the informal or unregulated market as well.
“All medical products must be approved and obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional when in doubt,” WHO said.
Pertinently, even when WHO has flagged these four drugs as being responsible for killing 66 such children, there has been no warning from India’s Central Drugs Standard Control Organisation (CDSCO), Drugs Controller General of India (DCGI), or India’s health ministry. Since the company is India based, there is a high chance of these medicines having penetrated the Indian market as well.