India Launches Online National Drug Licensing System

Strengthening Pharmaceutical Safety

India Launches Online National Drug Licensing System: India has introduced the Online National Drug Licensing System (ONDLS) to ensure the highest standards of drug safety and traceability across the pharmaceutical supply chain. The system, launched by the Central Drugs Standard Control Organisation (CDSCO) under the Union Health Ministry, allows real-time tracking of pharmaceutical-grade solvents and ensures that only verified ingredients are used in medicine production.

This move comes after a series of tragic incidents involving toxic cough syrups, where contamination by diethylene glycol (DEG) led to child fatalities. The initiative reflects India’s effort to restore confidence in its drug exports and domestic pharmaceutical manufacturing processes.

Static GK fact: The CDSCO functions under the Drugs and Cosmetics Act, 1940, and is the national regulatory authority for pharmaceuticals and medical devices in India.

Background to the Reform

The immediate trigger for ONDLS was the Madhya Pradesh cough syrup tragedy, where DEG contamination caused multiple child deaths. Investigations revealed severe lapses in ingredient sourcing and quality verification, prompting concerns from the World Health Organization (WHO). Similar DEG poisoning cases have occurred in India since the 1970s, making this reform long overdue.

Static GK fact: The first major DEG poisoning case in India was reported in 1972, in the state of Maharashtra, leading to over 80 deaths.

Key Features of ONDLS

The ONDLS is a centralised digital platform designed to:

• Monitor and license pharma-grade solvent production.
• Track each batch from manufacturing to end-user level.
• Verify documentation, including certificates of analysis.
• Automatically block unverified or non-compliant batches.

Originally launched to digitise licensing, ONDLS has now been enhanced to focus on end-to-end ingredient traceability, especially for liquid formulations like syrups where contamination risks are high.

Solvents Under Scrutiny

The CDSCO has identified several high-risk pharmaceutical solvents for mandatory tracking under ONDLS. These include glycerin, propylene glycol, sorbitol, maltitol, ethyl alcohol, and hydrogenated starch hydrolysate. While these are safe in pure form, they can become toxic if adulterated with industrial-grade substitutes or contaminated with diethylene glycol.

Static GK Tip: Diethylene glycol (DEG) is a colourless, odourless liquid used in antifreeze and brake fluids but is lethal for human consumption.

Implementation and Oversight

The CDSCO circular issued on October 22, 2025, mandates all solvent manufacturers to make batch-wise entries under the ONDLS system. State-level drug controllers are responsible for inspections, compliance audits, and awareness campaigns to train stakeholders. A new “old licence management” module helps integrate previous licenses into the digital system for seamless tracking.

The initiative is supported by a high-level committee chaired by the Union Health Secretary, ensuring coordination among states and central agencies.

Static GK fact: India is the world’s third-largest producer of pharmaceuticals by volume, contributing to over 20% of global generic drug exports.

Expected Outcomes

The ONDLS is expected to significantly reduce incidents of drug contamination, improve global export credibility, and strengthen India’s position as a trusted pharmaceutical hub. By combining digital oversight with stringent regulatory checks, the government aims to ensure that such tragedies are not repeated in the future.

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India Launches Online National Drug Licensing System: