India Launches Online National Drug Licensing System (ONDLS) After Cough Syrup Deaths

• Following recent child deaths linked to contaminated cough syrups , the Central Drugs Standard Control Organisation (CDSCO) has launched the Online National Drug Licensing System (ONDLS) to monitor and regulate high-risk pharmaceutical solvents.

Purpose and Function:

• The ONDLS portal enables real-time tracking of solvent batches used in drug manufacturing.

• All state and union territory drug controllers have been directed to implement the system for licensing and compliance.

• Manufacturers must upload detailed batch data , including certificates of analysis and buyer information , to ensure transparency and traceability.

• Unverified or unlicensed solvent batches will be blocked from market entry .

Background:

• The move follows child fatalities in Madhya Pradesh caused by syrups contaminated with diethylene glycol (DEG) .

• Investigations revealed lapses in ingredient sourcing and quality control .

• The World Health Organization (WHO) had issued a global alert over such contamination risks in paediatric medicines.

High-Risk Solvents Identified:

• Ten solvents under scrutiny include glycerin, propylene glycol, sorbitol, maltitol, ethyl alcohol, and hydrogenated starch hydrolysate .

• These ingredients are safe when pure but can become toxic if adulterated with industrial-grade chemicals.

Regulatory Action:

• Directive issued by Dr Rajeev Singh Raghuvanshi , Drugs Controller General of India .

• Decision followed a high-level review meeting chaired by the Union Health Secretary on October 5, 2025 .

• Existing manufacturers must migrate to the new system under an “old licence management” module for continued compliance.

Key GK Facts:

• DEG contamination has caused poisoning incidents in India since the 1970s , prompting multiple reforms.

• The CDSCO , under the Ministry of Health and Family Welfare , is India’s apex drug regulatory authority .

• ONDLS was initially designed to digitise licensing and compliance across India’s pharmaceutical industry.

Significance:

• Ensures end-to-end traceability of pharmaceutical solvents.

• Strengthens drug quality oversight and prevents future contamination incidents.

• Reinforces India’s commitment to pharmaceutical safety and public