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Haryana FDA Tightens Controls on Industrial-Grade Solvents to Prevent Drug Contamination
The state drug controller, Lalit Kumar Goel, has made it compulsory for manufacturers, importers, traders and distributors to affix prominent warning labels stating “Not for Pharmaceutical Use” on containers of industrial-grade solvents that could pose contamination risks if misused in drug production. This warning must appear not only on packaging but also on all related sale invoices and delivery challans.
- By Newsdesk
- New Delhi
- Jan 05, 2026
In a decisive step to fortify drug safety standards, the Haryana Food and Drug Administration (FDA) has issued stringent new guidelines governing the labelling and sale of high-risk industrial-grade solvents and excipients. The directive, signed on December 31, 2025, mandates enhanced transparency and traceability across the pharmaceutical raw material supply chain.
The state drug controller, Lalit Kumar Goel, has made it compulsory for manufacturers, importers, traders and distributors to affix prominent warning labels stating “Not for Pharmaceutical Use” on containers of industrial-grade solvents that could pose contamination risks if misused in drug production. This warning must appear not only on packaging but also on all related sale invoices and delivery challans.
Haryana’s revised rules also require that these high-risk chemicals including substances like propylene glycol and glycerin, which in the past have been linked to fatal contamination incidents be sold only in sealed, tamper-proof containers with complete batch-traceability information.
The move aligns with the Central Drugs Standard Control Organization’s (CDSCO) nationwide push for a zero-tolerance approach against toxic impurities such as diethylene glycol (DEG) and ethylene glycol (EG) - contaminants associated with serious health issues, particularly in children.
To strengthen oversight, manufacturers must now register on the Online National Drugs Licensing System (ONDLS) portal, enabling regulators to monitor batch-wise distribution and compliance more effectively.
Haryana Health Minister Arti Singh Rao has underscored the government’s commitment to rigorous enforcement. Ongoing joint inspections with central authorities have already yielded dozens of checks and the collection of hundreds of samples for testing. Non-compliance in some cases has led to suspension of production orders and cancellation of manufacturing licences.
Regulators have warned that firms failing to adhere to the new labelling and sale requirements will face strict action, including prosecution. With these measures, authorities hope to restore confidence in India’s pharmaceutical supply chain and prevent future public health tragedies linked to contaminated medicines.