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Karnataka government has made a major revision in the withdrawal timeline for not-of-standard quality (NSQ) medicines, reducing it from 30 days to just 3 days. The change is aimed at improving patient safety by ensuring that substandard drugs are promptly removed from the market. The move also reinforces accountability among manufacturers and distributors to maintain higher quality standards.
The state Food and Drug Administration (FDA) has also declared 59 samples as NSQ following routine inspections. The department's enforcement wing had conducted surprise inspections to pick up drug samples at random. These samples were found to be non-compliant with regulatory standards, prompting necessary enforcement actions.
Now, this has raised significant concern among the public and the government has now cautioned and taken on the onus to warn the retail chemists and wholesalers across the state and those attached to hospitals to refrain from stocking these drugs. It has also alerted the public not to purchase these drugs and also the medical practitioners to ensure prescribing such formulations.
Last month, the FDA filed 29 legal cases against companies for violations of the Drugs and Cosmetics Act & Rules. Drugs labelled as NSQ fail to meet prescribed quality benchmarks upon laboratory testing. These deficiencies can compromise both the safety and efficacy of the medicines. As part of its ongoing surveillance efforts, the Central Drugs Standard Control Organization (CDSCO) routinely publishes lists of NSQ drugs to alert healthcare stakeholders and enable timely recalls.
The companies manufacturing these drugs have not just been from Karnataka but across the country. The drugs span from antipyretics, to diabetes, hypertensive, gastrointestinal to cardiac and chronic conditions like cholesterol, to name a few. Some of these are Panoxen (diclofenac sodium and paracetamol, povidone iodine solution, methylcobalamin, cefixime, glimipride & metformin, sodium chloride injections. Vitamin B complex, rosuvastin, pantoprazole, ofloxacin and orinidazole, ranitidine hydrochloride injections, telmasartin, adrenline bitarate injections esomeprazole, sodium valproate, to name a few.
“Out of 279 special inspections across the state, the department also recalled substandard drugs worth Rs. 40 lakh in July 2025 under NSQ. The withdrawal timeline for NSQ drugs has been reduced from 30 days to three,” stated Karnataka health and family welfare minister Gundu Rao.
Our FDA has issued show-cause notices to 231 pharmacies for selling drugs like sleeping tablets and antibiotics without prescriptions. Now the FDA is continuing its surveillance to ensure the safety, efficacy, and quality of drugs and consumables available in the state. These companies identified in the NSQ drug list have been notified, and steps are being taken to prevent the distribution and sale of these substandard products, he added.
NSQ drugs those that do not meet the quality standards set by regulatory authorities. These standards include purity, strength, dissolution rate, and labelling accuracy. The identification of NSQ drugs is based on the analysis of drug samples collected from the market. The drugs were tested at the department’s Drug Test Lab to ascertain the contents of the drug and its quality. The companies engaged in the production of these drugs have now been issued warning notices to rectify the manufacturing processes, Rao said.
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