India's Drug Regulator Proposes Guidelines on High-Risk Solvents Following Pediatric Deaths
Drug regulator drafts guidelines on high-risk solvents after tainted syrup deaths in kids
The Economic TimesImage: The Economic Times
India's drug regulatory authority is drafting guidelines for high-risk solvents like Propylene Glycol, Diethylene Glycol (DEG), and Ethylene Glycol (EG) used in pediatric medicines. This comes after multiple incidents of contaminated cough syrups resulted in child fatalities, prompting urgent regulatory action to ensure safety.
- 01India's drug regulator is addressing safety concerns over high-risk solvents in pediatric medicines.
- 02Contaminated cough syrups have led to child fatalities, raising alarm among health authorities.
- 03The Drugs Consultative Committee (DCC) is assessing current formulations using these solvents.
- 04There is a push for alternative excipients and safer formulation methods.
- 05Last year, at least 23 children died after consuming cough syrup with dangerously high levels of DEG.
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In response to growing concerns over the safety of pediatric medicines, India's drug regulatory authority is drafting guidelines to regulate the use of high-risk solvents such as Propylene Glycol, Diethylene Glycol (DEG), and Ethylene Glycol (EG). This initiative follows several tragic incidents where contaminated cough syrups led to the deaths of children. The Drugs Consultative Committee (DCC) highlighted that many oral liquid formulations are currently manufactured with these solvents, which pose significant safety risks due to potential contamination. At its 67th meeting, the DCC suggested that the Central Drugs Standard Control Organization (CDSCO) engage with stakeholders to evaluate the situation and gather information on existing formulations. The urgency of this action is underscored by incidents involving cough syrups made in India, where at least 23 children died after consuming Coldrif syrup, which was found to contain DEG at levels exceeding permissible limits by 500 times. The DCC is also exploring the feasibility of using safer formulation alternatives.
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These guidelines aim to enhance the safety of pediatric medicines, potentially preventing future tragedies involving contaminated products.
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