Haryana FDA Launches Digital Monitoring to Track High-Risk Pharmaceutical Solvents

This mandatory digital registration on the ONDLS portal enables real-time oversight of critical ingredients, placing Haryana at the forefront of enforcing stringent quality norms after recent contamination incidents.

The Haryana Food and Drugs Administration (FDA) has enforced a major regulatory overhaul and introduced a new digital monitoring system to track high-risk pharmaceutical solvents.

The action follows a public alert on the fatal contamination of cough syrups with industrial chemicals and is part of a national directive issued by the Central Drugs Standard Control Organisation (CDSCO).

According to Lalit Kumar Goel, the state drug controller of Haryana, official communication from the FDA in Madhya Pradesh and Gujarat confirmed that certain drug formulations contained diethylene glycol (DEG) impurities beyond permissible limits.

These products were declared adulterated and not of Standard Quality (NSQ). The findings, which specifically implicated cough syrups like Respifresh TR and Relife, prompted Haryana FDA to alert all drug inspectors to maintain strict vigilance, draw samples, and seize remaining contaminated stocks.

Goel also warned solvent manufacturers, through the Haryana Pharmaceutical Manufacturers Association, against using contaminated raw materials leading to DEG adulteration. He emphasized the importance of maintaining a secure pharmaceutical supply chain, he told Pharmabiz in a telephonic talk.

Following the CDSCO directive on October 22, 2025, Goel issued a memo instructing solvent manufacturers to register on the Online National Drug Licensing System (ONDLS) portal.

“The focus of the new digital watch is a list of high-risk solvents essential for liquid oral medicines, including propylene glycol, glycerin, sorbitol, and various polyethylene glycols. Under the new rules, manufacturers are required to upload comprehensive details for every batch produced. This includes the total quantity, the official Certificate of Analysis (CoA) to verify purity, and the specific details of every vendor or pharmaceutical company purchasing the material,” he said.

In a cooperative response, the Haryana Pharmaceutical Manufacturers Association (HPMA) extended support to the transparency initiative.

HPMA officials confirmed that none of their current member units are engaged in the manufacturing of the high-risk solvents now under digital surveillance. They also affirmed their readiness to share information immediately if any member unit receives such compounds, ensuring full compliance and accountability within the state’s industry.

This mandatory digital registration on the ONDLS portal enables real-time oversight of critical ingredients, placing Haryana at the forefront of enforcing stringent quality norms after recent contamination incidents.

By mandating batch-level tracking of solvents, the state aims to secure the integrity of every medicine produced and move towards a contamination-free pharmaceutical ecosystem.

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