India's Drug Regulator to Review High-Risk Solvents in Cough Syrups After Child Fatalities
Drug Regulator To Meet Pharma Industry To Review High-Risk Solvents In Cough Syrups
News 18
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Following the tragic deaths of 24 children linked to Coldrif cough syrup, India's Central Drugs Standard Control Organisation (CDSCO) is convening a meeting with the pharmaceutical industry to review the use of high-risk solvents in pediatric oral liquid formulations. This includes assessing potential contamination risks from solvents like propylene glycol.
- 01CDSCO is addressing safety concerns after the Coldrif cough syrup tragedy.
- 02The review focuses on high-risk solvents such as propylene glycol and its impurities.
- 03A meeting with industry stakeholders is scheduled for May 21, 2026.
- 04The Coldrif incident highlighted severe contamination risks in cough syrups.
- 05Regulatory actions may include reformulating or restricting the use of these solvents.
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In response to the Coldrif cough syrup tragedy that resulted in the deaths of 24 children in Madhya Pradesh, the Central Drugs Standard Control Organisation (CDSCO) is set to meet with the pharmaceutical industry to discuss the safety of high-risk solvents used in pediatric formulations. The Drugs Controller General of India, Dr. Rajeev Singh Raghuvanshi, raised concerns regarding solvents like propylene glycol and its impurities, which have been linked to contamination risks in oral liquid formulations. The memorandum issued on May 11, 2026, highlights the urgent need for consultations with stakeholders to assess current manufacturing practices and consider alternative excipients. The tragic incident involved Coldrif syrup, produced by Sresan Pharmaceuticals, which contained 48.6% diethylene glycol, far exceeding the permissible limit. Following this, the WHO issued a global alert, and significant regulatory actions were taken, including the permanent revocation of Sresan Pharma's license and the arrest of its owner for culpable homicide. The upcoming meeting aims to ensure the safety of pediatric medications and prevent future tragedies.
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This review could lead to stricter regulations on cough syrups, ensuring safer formulations for children, which is crucial for protecting public health.
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