WHO seeks clarity on global distribution of contaminated cough syrup after fatalities in India

WHO seeks clarity on global distribution of contaminated cough syrup after fatalities in India

At least 20 children in Madhya Pradesh have died, with five others in critical condition due to kidney infections caused by the consumption of the contaminated cough syrup. The syrup, which contained harmful substances like Diethylene Glycol (DEG) and Ethylene Glycol (EG), has been deemed unsafe for consumption.

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An advisory issued by the DCGI on October 7 revealed concerns raised during inspections of manufacturing facilities.An advisory issued by the DCGI on October 7 revealed concerns raised during inspections of manufacturing facilities.
Business Today Desk
  • Oct 9, 2025,
  • Updated Oct 9, 2025 3:59 PM IST

The World Health Organisation (WHO) has reached out to Indian authorities seeking clarification on whether a cough syrup, Coldrif, linked to recent child deaths in India, was exported to other countries.

According to sources, the global health body is considering issuing a 'Global Medical Products Alert' regarding the cough syrup, which would warn other nations about potential risks posed by substandard or contaminated medicines.

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At least 20 children in Madhya Pradesh have died, with five others in critical condition due to kidney infections caused by the consumption of the contaminated cough syrup. The syrup, which contained harmful substances like Diethylene Glycol (DEG) and Ethylene Glycol (EG), has been deemed unsafe for consumption. Additionally, three children in Rajasthan have reportedly died after using the same product.

WHO's inquiries & Ongoing investigations

On Wednesday, WHO requested confirmation from Indian officials about the potential export of the affected cough syrup to other countries as part of routine trade procedures. The agency typically issues such alerts when substandard or contaminated medical products are found in the market.

The Drugs Controller General of India (DCGI) has also responded to the situation, directing state and union territory drug controllers to ensure testing of raw materials and finished pharmaceutical products before they are released into the market. This directive follows the tragic deaths of children in Madhya Pradesh linked to the consumption of contaminated cough syrup.

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Regulatory measures & Safety concerns

An advisory issued by the DCGI on October 7 revealed concerns raised during inspections of manufacturing facilities. Investigations into drugs declared 'Not of Standard Quality' indicated that many manufacturers failed to adequately test each batch of excipients and active ingredients to ensure compliance with prescribed standards before use in product formulations.

The advisory urged all state and UT drug controllers to take measures to ensure that manufacturers conduct thorough testing of materials before production and distribution. The DCGI also emphasized the importance of a robust vendor qualification system to ensure that raw materials are sourced from reliable, approved vendors.

This incident follows a 2023 order from the Centre, mandating pharmaceutical companies to include warnings on the packaging of certain drugs, particularly those containing chlorpheniramine maleate and phenylephrine, advising against their use for children under four years of age.

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(With inputs from PTI)

The World Health Organisation (WHO) has reached out to Indian authorities seeking clarification on whether a cough syrup, Coldrif, linked to recent child deaths in India, was exported to other countries.

According to sources, the global health body is considering issuing a 'Global Medical Products Alert' regarding the cough syrup, which would warn other nations about potential risks posed by substandard or contaminated medicines.

Advertisement

At least 20 children in Madhya Pradesh have died, with five others in critical condition due to kidney infections caused by the consumption of the contaminated cough syrup. The syrup, which contained harmful substances like Diethylene Glycol (DEG) and Ethylene Glycol (EG), has been deemed unsafe for consumption. Additionally, three children in Rajasthan have reportedly died after using the same product.

WHO's inquiries & Ongoing investigations

On Wednesday, WHO requested confirmation from Indian officials about the potential export of the affected cough syrup to other countries as part of routine trade procedures. The agency typically issues such alerts when substandard or contaminated medical products are found in the market.

The Drugs Controller General of India (DCGI) has also responded to the situation, directing state and union territory drug controllers to ensure testing of raw materials and finished pharmaceutical products before they are released into the market. This directive follows the tragic deaths of children in Madhya Pradesh linked to the consumption of contaminated cough syrup.

Advertisement

Regulatory measures & Safety concerns

An advisory issued by the DCGI on October 7 revealed concerns raised during inspections of manufacturing facilities. Investigations into drugs declared 'Not of Standard Quality' indicated that many manufacturers failed to adequately test each batch of excipients and active ingredients to ensure compliance with prescribed standards before use in product formulations.

The advisory urged all state and UT drug controllers to take measures to ensure that manufacturers conduct thorough testing of materials before production and distribution. The DCGI also emphasized the importance of a robust vendor qualification system to ensure that raw materials are sourced from reliable, approved vendors.

This incident follows a 2023 order from the Centre, mandating pharmaceutical companies to include warnings on the packaging of certain drugs, particularly those containing chlorpheniramine maleate and phenylephrine, advising against their use for children under four years of age.

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(With inputs from PTI)

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