India's Drug Regulator Responds To Child Fatalities With New Cough Syrup Testing Guidelines

India's drug regulator, CDSCO, has issued a directive for rigorous testing of cough syrup ingredients following child fatalities in Madhya Pradesh. The advisory stresses compliance with drug regulations to enhance public safety and restore trust in the pharmaceutical industry.

In response to recent child fatalities in Madhya Pradesh linked to tainted cough syrups, India's primary drug regulator has taken decisive action. The Central Drugs Standard Control Organisation (CDSCO) has issued a directive to state and Union Territory drug controllers. This advisory mandates thorough testing of all raw materials and finished products before they are used or sold.

The advisory, dated October 7, 2025, was sent by Dr. Rajeev Singh Raghuvanshi, the Drug Controller General of India (DCGI). It underscores the necessity of testing raw materials, including excipients, prior to their use in manufacturing cough syrups and other formulations. This step is crucial for ensuring product safety.

Ensuring Compliance with Drug Regulations

Recent inspections have revealed that many manufacturers fail to test each batch of excipients and active ingredients for compliance with prescribed standards. Such lapses violate the Drugs Rules, 1945, which require testing in approved laboratories and maintaining complete records. The DCGI's advisory highlights these issues and calls for stricter adherence to regulations.

The letter from the DCGI states: "It has been observed that manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients before use in the manufacturing of drug formulations." This oversight poses significant risks to public health.

Strengthening Quality Control Systems

State regulators have been urged to intensify inspections and ensure no medicine batch is released without proper testing. They must monitor manufacturers' quality-control systems and take necessary measures for testing, sampling, and verification before market release. This approach aims to prevent future incidents like those seen in Madhya Pradesh.

The advisory requests state regulators: "You are requested to ensure that the testing of each batch of the drugs as well as raw materials used in manufacturing including excipients is carried out either in the manufacturer's own laboratory or in a laboratory approved by the licensing authority." Acknowledgment receipts are also requested from state regulators.

Global Concerns Over Quality Oversight

The recent incident in Madhya Pradesh has reignited concerns about quality oversight and raw material testing within India. Global health authorities, such as the World Health Organization (WHO), have repeatedly urged India to enhance its surveillance and regulatory systems to prevent such tragedies from occurring again.

Excipients are inactive substances used in medicines; they don't have therapeutic effects but are essential for making drugs stable, safe, and consumable. In cough syrups, excipients include glycerin, propylene glycol, sorbitol, and sweeteners that provide texture, taste, and fluidity.

Rebuilding Trust in India's Pharmaceutical Industry

The Centre's latest directive aims to tighten compliance at the state level to avoid repeating the cough syrup contamination crisis that has tarnished India's reputation as the "pharmacy of the world." By enforcing stricter regulations on drug testing, India seeks to restore trust in its pharmaceutical industry both domestically and internationally.

Experts believe that if mandatory checks had been rigorously followed earlier, tragic child deaths linked to contaminated cough syrups—both within India (Rajasthan and Jammu) and abroad (The Gambia and Uzbekistan)—could likely have been prevented. Past investigations revealed toxic industrial solvents like diethylene glycol (DEG) and ethylene glycol (EG) were present due to inadequate raw material testing before production.