Strengthening Drug Oversight
India Launches Digital Drug Licensing System to Prevent Cough Syrup Tragedies: In response to a series of cough syrup–related deaths, India has introduced the Online National Drug Licensing System (ONDLS) to monitor pharmaceutical solvents. The system, launched by the Central Drugs Standard Control Organisation (CDSCO), enables real-time tracking of ingredients used in medicine production. It aims to ensure that only verified batches of solvents enter the pharmaceutical supply chain.
Static GK fact: The CDSCO operates under the Ministry of Health and Family Welfare and serves as India’s top authority for approving and regulating drugs.
Trigger Behind the Move
The reform follows multiple child fatalities in Madhya Pradesh, where cough syrups were found contaminated with diethylene glycol (DEG) — a toxic industrial solvent. Investigations exposed major gaps in ingredient sourcing and batch verification. The World Health Organization (WHO) issued a global alert warning about the dangers of unregulated syrup exports, especially in paediatric formulations.
Static GK fact: Diethylene glycol poisoning incidents have been recorded in India since the 1970s, leading to stricter pharmaceutical regulations over time.
High-Risk Solvents Under Watch
The CDSCO has listed ten high-risk solvents, including glycerin, sorbitol, propylene glycol, ethyl alcohol, and hydrogenated starch hydrolysate. While these are essential for syrup formulations, they can be hazardous when adulterated. The directive was officially signed by Dr Rajeev Singh Raghuvanshi, the Drugs Controller General of India, following a review meeting chaired by the Union Health Secretary on October 5, 2025.
Static GK Tip: Propylene glycol and glycerin are common pharmaceutical excipients used for smooth consistency in syrups but must meet pharma-grade purity standards.
Real-Time Licensing and Compliance
Under the ONDLS framework, all solvent manufacturers must upload batch-wise data — including certificates of analysis, supplier details, and buyer information. Regulators are empowered to block unverified batches instantly. Existing licence holders are required to register under the “old licence management” module to maintain compliance.
Static GK fact: ONDLS was initially developed to digitise India’s drug licensing system, promoting transparency and coordination between state and central regulators.
Nationwide Implementation and Impact
State drug controllers have been instructed to conduct training sessions, inspections, and awareness campaigns to ensure full implementation of ONDLS. The initiative represents a major digital reform in India’s pharmaceutical governance, closing long-standing regulatory gaps. By ensuring end-to-end traceability, the system aims to restore public confidence in medicine safety and protect citizens from contaminated formulations.
Static GK Tip: India ranks among the world’s top three pharmaceutical producers by volume, making drug quality regulation a matter of national and global significance.
Static Usthadian Current Affairs Table
India Launches Digital Drug Licensing System to Prevent Cough Syrup Tragedies:
| Topic | Detail |
| Launch Authority | Central Drugs Standard Control Organisation (CDSCO) |
| Portal Name | Online National Drug Licensing System (ONDLS) |
| Launch Date | October 22, 2025 |
| Key Trigger | Cough syrup deaths due to diethylene glycol contamination |
| High-Risk Solvents | Glycerin, propylene glycol, sorbitol, ethyl alcohol, maltitol |
| Supervising Official | Dr Rajeev Singh Raghuvanshi, DCGI |
| Ministry Involved | Ministry of Health and Family Welfare |
| Global Agency Alert | World Health Organization (WHO) |
| Digital Compliance Feature | Real-time batch tracking and old licence management module |
| Broader Objective | Strengthen quality control and prevent toxic contamination in drugs |
