The World Health Organization (WHO) has requested clarification from Indian authorities on whether the toxic Coldrif cough syrup, linked to the deaths of at least 22 children, was exported to other countries.
The WHO will decide on issuing a Global Medical Products Alert once it receives an official response.
Cough Syrup Linked to Child Deaths
The syrup, found to contain Diethylene Glycol (DEG) and Ethylene Glycol (EG) — both toxic substances — has caused widespread concern. So far, 22 children in Madhya Pradesh have died after consuming the syrup, and five others are critically ill with kidney infections. Additionally, three deaths have been reported in Rajasthan.
DCGI Strengthens Safety Checks
In response, the Drugs Controller General of India (DCGI) issued an advisory on October 7, directing all state and Union Territory drug controllers to enforce strict quality checks on raw materials and finished pharmaceutical products.
The advisory highlighted serious lapses in manufacturer compliance:
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Many companies do not test every batch of excipients and active ingredients before using them in formulations.
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State and UT authorities have been instructed to ensure strict monitoring during inspections, sensitize manufacturers, and verify robust vendor qualification systems.
Concerns Over Pharmaceutical Quality
The deaths in Madhya Pradesh’s Chhindwara district have renewed concerns about drug quality in India. This is not the first instance of scrutiny; in 2023, the government mandated warnings on cough syrup labels for children below four years.
The WHO’s inquiry reflects global concern about the safety of Indian pharmaceutical exports, emphasizing the need for stringent manufacturing standards to prevent further tragedies.
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