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 In a significant move to safeguard public health, Haryana state drug controller (SDC) Lalit Kumar Goel has issued a strict advisory to pharmaceutical manufacturers regarding the labelling and sale of high-risk industrial-grade solvents and excipients.
Dated December 31, 2025, the directive aims to curb the misuse of industrial chemicals in medicine production following nationwide concerns over contaminated cough syrups. All stakeholders, including traders, importers, and distributors, are now required to adhere to rigorous new safety standards with immediate effect.
Under the new regulations, every container of high-risk industrial-grade solvents must carry a clear and legible warning label stating ‘Not for Pharmaceutical Use’. This caution is not limited to the packaging alone, it must also be prominently printed on all transaction documents, including sale invoices and delivery challans. The SDC emphasized that these measures are essential to ensure quality and safety within the pharmaceutical supply chain.
The advisory further mandates that the sale of high-risk solvents and excipients must only occur in original, sealed, tamper-proof containers. These containers must be accompanied by complete labelling and batch-traceability information to prevent any potential for unauthorized tampering or contamination. The directive specifically targets substances like propylene glycol and glycerin, which have previously been linked to fatal health crises when contaminated with toxic industrial chemicals.
This state-level action follows a broader national push by the Central Drugs Standard Control Organization (CDSCO) to implement a ‘zero-tolerance’ approach toward toxic impurities like diethylene glycol (DEG) and ethylene glycol (EG). These substances are known to cause severe health complications, including kidney failure and neurological disorders, particularly in children. To facilitate better oversight, manufacturers are also required to register on the digital Online National Drugs Licensing System (ONDLS) portal to track batch-wise details.
Haryana health minister Arti Singh Rao has reaffirmed the state's commitment to rigorous enforcement, noting that continuous inspections are already underway. Joint efforts with central authorities have already led to dozens of inspections and collection of hundreds of samples for testing. In some instances, non-compliance has already resulted in the suspension of production orders and the cancellation of manufacturing licenses for firms failing to meet prescribed safety standards.
Authorities have warned that any failure to comply with these new labelling and sale requirements will invite severe regulatory action, including prosecution. As the pharmaceutical industry works to meet these standards as early as possible, the focus remains on building a transparent and contamination-free drug manufacturing ecosystem. By tightening controls over the raw material supply chain, officials hope to restore public trust and prevent future health tragedies.
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