NEW DELHI: The Central Drugs Standard Control Organisation , the national regulatory authority on quality of drugs, issued an urgent alert to states and union territories on Wednesday after children's deaths were linked to contaminated cough syrups .
The regulator asked state and UT drug controllers to ensure that manufacturers comply with drug-testing rules, monitor production during inspections, and sensitise manufacturers through circulars. States and union territories were also asked to acknowledge the alert and report the measures taken to prevent further risks to children’s health.
"All the State/ UT Drug Controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc. Further, it shall also be ensured that the manufacturers have robust vendor qualification system in place and use raw materials including excipients from reliable approved vendors only. You are requested to acknowledge the receipt of this letter and intimate the action taken in this regard," the statement read.
CDSCO also instructed that companies maintain robust vendor qualification systems and source raw materials only from reliable, approved suppliers.
The regulator further emphasised that, as per the Drugs Rules, manufacturers must test every batch of raw material and final product either in their own laboratory or in a lab approved by the licensing authority. It also said that detailed records of these tests must also be maintained.
Also read: Cough syrup deaths: 'Release doctor immediately,' demands FAIMA; advises Centre on safety measures
The alert comes in the wake of reports from Chhindwara, Madhya Pradesh, where several child deaths were allegedly connected to poor-quality cough syrups.
CDSCO said inspections at manufacturing facilities and investigations into drugs declared “Not of standard quality” revealed that manufacturers were not testing each batch of raw materials, including active and inactive ingredients, before using them in production.
Meanwhile, the World Health Organisation (WHO) on Wednesday sought clarification from Indian authorities on the export of Coldrif. Reuters reported that the WHO wanted to know if the syrup had been shipped abroad. Based on responses from Indian health officials, the global body said it would assess whether a Global Medical Products Alert on Coldrif syrup was needed.
The regulator asked state and UT drug controllers to ensure that manufacturers comply with drug-testing rules, monitor production during inspections, and sensitise manufacturers through circulars. States and union territories were also asked to acknowledge the alert and report the measures taken to prevent further risks to children’s health.
"All the State/ UT Drug Controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc. Further, it shall also be ensured that the manufacturers have robust vendor qualification system in place and use raw materials including excipients from reliable approved vendors only. You are requested to acknowledge the receipt of this letter and intimate the action taken in this regard," the statement read.
CDSCO issues urgent alert to State/UT Drug Controllers after child deaths linked to contaminated cough syrups. pic.twitter.com/nLQtTIRlZB
— Press Trust of India (@PTI_News) October 8, 2025
CDSCO also instructed that companies maintain robust vendor qualification systems and source raw materials only from reliable, approved suppliers.
The regulator further emphasised that, as per the Drugs Rules, manufacturers must test every batch of raw material and final product either in their own laboratory or in a lab approved by the licensing authority. It also said that detailed records of these tests must also be maintained.
Also read: Cough syrup deaths: 'Release doctor immediately,' demands FAIMA; advises Centre on safety measures
The alert comes in the wake of reports from Chhindwara, Madhya Pradesh, where several child deaths were allegedly connected to poor-quality cough syrups.
CDSCO said inspections at manufacturing facilities and investigations into drugs declared “Not of standard quality” revealed that manufacturers were not testing each batch of raw materials, including active and inactive ingredients, before using them in production.
Meanwhile, the World Health Organisation (WHO) on Wednesday sought clarification from Indian authorities on the export of Coldrif. Reuters reported that the WHO wanted to know if the syrup had been shipped abroad. Based on responses from Indian health officials, the global body said it would assess whether a Global Medical Products Alert on Coldrif syrup was needed.
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