Drug regulator drafts guidelines on high-risk solvents after tainted syrup deaths in kids

New Delhi: India's drug regulator is working on regulatory guidelines governing the use of high-risk solvents in the wake of mounting concerns over the use of Propylene Glycol and its toxic impurities Diethylene Glycol (DEG) and Ethylene Glycol (EG) in oral liquid medicines, particularly syrups and drops intended for paediatric use.

Earlier multiple incidents of contaminated cough syrups leading to children's death had come forward.

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The experts committee under the drug regulatory authority had also flagged that several oral liquid formulations are currently being manufactured using such high-risk solvents, which pose potential safety risks due to possible contamination with DEG and EG. The Drugs Consultative Committee (DCC), at its 67th meeting held on November last year, opined that CDSCO should undertake consultations with stakeholders to assess the current situation and collate details of formulations being manufactured using such high-risk solvents, before taking further appropriate regulatory action.

The committee flagged that several oral liquid formulations are currently being manufactured using such high-risk solvents, which pose potential safety risks due to possible contamination with DEG and EG. The DCC also deliberated on the feasibility of switching to alternative excipients and safer formulation approaches.

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The urgency behind the move gains significance as many u fortunate incidents of deaths in children came forward in India and abroad due to made in India cough syrups in the past.

Last year dozens of young children in Madhya Pradesh and Rajasthan fell ill and many died after consuming locally sold cough medicines. At least 23 children died after consuming Coldrif syrup with one batch found to contain over 48% DEG -500 times the permissible limit.