November 22, 2025

The World Health Organization (WHO) has formally requested clarification from Indian health authorities regarding whether the cough syrup Coldrif, linked to the deaths of multiple children, was exported abroad.

This move marks a critical moment in global pharmaceutical safety oversight and raises urgent questions about export surveillance, regulatory transparency, and international risk management.

Background: Toxic Cough Syrup & Child Fatalities

In recent weeks, at least 17 children under five died in Madhya Pradesh after consuming Coldrif, a pediatric cough syrup produced by Srisan Pharmaceuticals in Tamil Nadu.

Laboratory tests revealed Coldren contained diethylene glycol (DEG) in concentrations nearly 500× above permissible limits.

  • States across India have banned the product and regulatory agencies launched investigations into manufacturing and quality control lapses.
  • The Indian government's inspections discovered failures in raw material testing and final-product quality control at certain pharmaceutical plants.

Given India’s role as a major exporter of generic medicines, the WHO’s query seeks to determine if contaminated batches may have reached foreign markets — a scenario that would trigger a Global Medical Products Alert.

Key Issues & Implications for Regulatory Affairs

1. Export Surveillance & Traceability

If Coldrif was exported, countries receiving Indian pharmaceutical products could face public health risks. This underscores the importance of traceable supply chains, batch-level export logs, and export certification compliance.

2. Global Medical Product Alerts & International Coordination

A WHO alert would require rapid, coordinated action across national regulators—issuing recalls, halting distribution, and notifying healthcare providers. For Maven’s clients, that means being inspection-ready and having cross-border recall protocols.

3. Strengthened Quality Control & Third-Party Audits

This incident highlights the need for robust QC systems, third-party oversight, and supplier qualification (especially for excipients and solvents susceptible to DEG contamination).

4. Regulatory Reputation & Export Confidence

A safety breach with international ramifications erodes global trust in “made in India” pharmaceuticals. Exporters must adopt compliance transparency, audit trials, and proactive risk management to restore confidence.

5. Precedents from Past Incidents

India has faced similar crises before — for example, the 2022 Gambia cough syrup scandal, in which contaminated Indian syrups were implicated in child deaths abroad. That precedent amplifies scrutiny now.

What Maven Regulatory Solutions Advises

  1. Immediate Export Review
     Conduct a full audit of export logs for all cough syrups (especially Coldrif). Flag any international recipients for regulatory notification and recall readiness.
  2. Batch Recall & Notification Protocols
     Prepare template recall notices, coordinate with foreign regulators, and use secure communication channels (e.g. Drug Regulatory Authority portals).
  3. Supplier & Process Controls
     Implement enhanced raw material testing (e.g. solvent purity, DEG assays) and require certificates of analysis from each upstream supplier.
  4. Regulatory Communication Strategy
     Be ready to liaise with WHO, foreign regulatory authorities, and customers — with transparent, factual, and timely disclosure.
  5. Preventive Risk Management
     Adopt risk-based audits, periodic external QC sampling, and regulatory intelligence monitoring to detect any emerging threats early.

Conclusion

The WHO’s request to India regarding Coldrif's export status is a red flag for the global pharmaceutical community. The stakes are high — a contaminated product crossing borders could have severe public health consequences and global regulatory fallout.

For pharmaceutical exporters, contract manufacturers, and regulatory stakeholders, this is a call to action: strengthen compliance, ensure export traceability, and adopt zero-tolerance quality systems.

Maven Regulatory Solutions stands ready to assist clients with export audits, recall readiness, supplier qualification, and global regulatory liaison to maintain compliance, safety, and trust across markets.