CDSCO Launches ONDLS to Track High-Risk Pharma Solvents

After?‍?‌‍?‍‌?‍?‌‍?‍‌ the discovery of diethylene glycol (DEG) in some cough syrups, the Central Drugs Standard Control Organisation (CDSCO) has launched a digitally monitored system on the Online National Drug Licensing System (ONDLS) portal.

The move is to ensure the production, quality, and sale of one of the most risky pharmaceutical solvents, like Propylene Glycol, Glycerin and Sorbitol which have been recommended for cases of contamination, are properly controlled.

The instruction is identified under the file number F. No. IT/ONDLS/MFG/Exp/2025/003. It was agreed upon by the Directorate General of Health Services, Ministry of Health and Family Welfare, and sent to all the Drug Controllers of States and Union Territories for implementation without delay.

The decision was taken after a senior-level meeting that the Secretary of Health and Family Welfare, Union Health, presided over on October 5, 2025. The meeting was aimed at reviewing the implementation of quality standards for drugs and the wise use of cough syrups, especially in pediatric care.

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According to the new regulations, manufacturers of solvents are to be issued or allowed to produce licenses on the ONDLS portal. They have to upload batch-wise data like certificates of analysis (CoA) and vendor's details. The CDSCO has stipulated that any solvent batch without complete digital compliance shall not be allowed on the market and therefore State and UT authorities are urged to take the implementation of this scheme seriously.

The reason for the action is to bring about digital transparency and quality assurance in India’s pharmaceutical supply chain, thus strengthening the government's commitment to public health ‍?‌‍?‍‌?‍?‌‍?‍‌safety.