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Four of the 19 cough syrup samples tested following the recent deaths of children were found to be ‘not of standard quality’, with one formulation showing dangerously high levels of diethylene glycol (DEG), the Health Ministry informed Parliament.
According to the ministry, “Chemical analysis of these 19 samples revealed that 15 samples were of standard quality, while 4 samples were declared not of standard quality.”
The syrup Coldrif, manufactured by Sreesan Pharmaceutical in Kanchipuram, Tamil Nadu, and allegedly consumed by the dead children, was found to have DEG content of 46.28% w/v, which is much higher than the permissible limit.
An inspection of Srison Pharmaceutical’s premises “revealed several significant and flagrant good manufacturing practices (GMP) violations, including unsanitary storage conditions.” The ministry said that CDSCO has taken up the matter of criminal action with the Tamil Nadu government.
The health ministry said over 700 cough syrup manufacturers have undergone intensive audit in coordination with state authorities, along with enhanced market surveillance by central and state drug regulators.
This update comes amid reports in early November Center is considering comprehensive regulatory changesThat includes ending over-the-counter access to cough syrup and making prescriptions mandatory. As per News 18 report, a proposal before the Drugs Consultative Committee has sought removal of these formulations from Schedule K citing “recent incidents due to contaminated cough syrups”.
Several states have started investigating the deaths. Committees were formed in Madhya Pradesh and Rajasthan This follows several deaths allegedly linked to contaminated syrups and medicines in the last 15 days. At least nine children in Madhya Pradesh’s Chhindwara died due to kidney failure allegedly caused by the contaminated formulation. According to News18, three child deaths were recorded in Rajasthan, including two in Sikar and one in Bharatpur under similar circumstances.
The ministry reiterated its stand that the recent measures are aimed at ensuring “timely regulatory action and strong quality monitoring” in the cough syrup manufacturing ecosystem.
(edited by : Shoma Bhattacharjee,