Drug Safety Audit: India Launches Nationwide Cough Syrup Inspections After Contamination Scandal

October 10, 2025 | National Health News

By Rajesh

Health and Regulation Journalist

Expert on pharma safety and policy

India's drug inspectors step up nationwide audits of syrup labs and factories.

After tragic child deaths linked to toxic cough syrups in Madhya Pradesh, India's drug regulator CDSCO has begun a comprehensive, nationwide audit of all cough syrup manufacturers. Global scrutiny from the WHO now centers on India's pharma supply chain, which aims to ensure stricter safety and quality controls—especially for medicines exported abroad.

At the heart of the crisis is the use of dangerous industrial solvents—diethylene glycol (DEG) and ethylene glycol (EG)—in place of pharma-grade propylene glycol. Three brands, Coldrif, Respifresh, and ReLife were found contaminated, leading to batch bans, factory closures, and arrests.

Why Is Propylene Glycol Safety So Important?

• Propylene glycol (PG) is a safe additive when used in the correct pharmaceutical grade. It acts as a solvent in cough syrups, helping dissolve medicines for easier ingestion.
• Dangers: Industrial-grade PG or substitution with DEG/EG (antifreeze components) is toxic—causes kidney failure, nervous system damage, and can be fatal. Children are especially vulnerable as their bodies can’t process toxins as well as adults.
• Improper sourcing: Some manufacturers used untested or contaminated PG, or replaced it with industrial solvents to cut costs, leading to deaths.

Health Fact: Only pharmaceutical-grade propylene glycol should ever be used in medicines—never substitutes or industrial chemicals.

Syrups under investigation: All batches to be checked for solvent quality and child safety.

Who Regulates Drug Safety? Roles of CDSCO & WHO

• CDSCO (Central Drugs Standard Control Organization): India’s top drug regulator, oversees manufacturing, testing, licensing, and compliance for all pharmaceutical products. Supervises routine audits and directs recalls, batch bans, and factory shutdowns.
• WHO (World Health Organization): Sets global pharma safety standards, issues medical alerts, and investigates causes of medicine-linked deaths worldwide. WHO tracks pharma exports and ensures Indian drugs meet international safety norms.
• Joint actions: WHO notified India of international cases and risks, triggering CDSCO’s expanded audit and stricter export controls.

Expert View: WHO's warning and CDSCO’s crackdown together aim to rebuild trust in India's medicine safety—with new audits and stricter global checks.

The Human Cost: Child Deaths in Madhya Pradesh

Tragic Cases: In Madhya Pradesh, at least 12 children died after consuming contaminated cough syrup containing DEG/EG from untested batches. Similar reports surfaced in Rajasthan. Hospitalized children showed symptoms of acute kidney injury and neurological decline.

• Victims: Children under 8, given prescribed syrup for cough and fever.
• Symptoms: Vomiting, confusion, lack of urination, rapid decline.
• Medical findings: DEG/EG detected in blood samples. No pharma-grade PG found.

Local health officials and WHO flagged manufacturing lapses and non-compliance, sparking the national crackdown.

Manufacturer	Status	Regulator Action
Sresan Pharma	Coldrif syrup, DEG found, batch banned, owner arrested	Factory closed, license revoked
Rednex Pharma	Respifresh syrup, DEG found, banned	Inspection ongoing
Shape Pharma	ReLife syrup, DEG found, halted	Batches recalled, audit ongoing

Labs now face surprise audits—inspectors check solvents and ingredient records of all batches.

What Is India Doing to Prevent Future Drug Contamination?

• Routine audit drive by CDSCO: Every cough syrup manufacturer faces inspection, spot checks, and testing of all batches.
• Mandatory supplier vetting: Factories must buy only pharma-grade PG from verified vendors. Ingredient and batch certificates are checked and logged.
• Export quality control: CDSCO and WHO jointly monitor batches for exports, requiring manufacturer self-declaration and frequent lab audits.
• Batch recalls & bans: Contaminated syrups are banned, factories closed, and owners prosecuted.
• Transparency push: Companies required to publish ingredient sources, batch testing results, and supplier records. Hospital alerts for adverse cases.
• Public advisory & reporting: Websites and helplines launched for reporting adverse effects, suspicious syrups, and fake medicines.

Expert Insight: “Strict audits, supplier controls, and public education are key to restoring trust and saving lives.”

— End of Report —

🩺 Drug Safety Fact Box

• Audit Trigger: Child deaths in Madhya Pradesh & Rajasthan after toxic syrup batches
• CDSCO: Conducts inspections, recalls, factory closures, and issues safety advisories
• WHO: Tracks global outbreaks, recommends export controls, and sets safety norms
• Safe medicine: Should list pharmaceutical-grade PG as solvent
• Reporting: Suspect adverse effects? Contact local FDA or CDSCO helplines immediately

Health Tip: See a doctor immediately if your child shows adverse symptoms after cough syrup use.

Sources:

• India Today, Hindustan Times & BBC News October 2025
• Business Standard, India Today
• Unsplash/Wikimedia Commons (Images)
• WHO/Indian Health Ministry Releases

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