Hyderabad: As many as 35 drugs manufactured in Telangana and supplied to states including Himachal Pradesh and Uttarakhand were flagged over the past year by the Central Drugs Standard Control Organisation (CDSCO) for being Not of Standard Quality (NSQ), raising serious concerns over patient safety and regulatory oversight.
The flagged list includes commonly used painkillers, antacids, antibiotics, anti-inflammatory and anti-parasitic medicines, many of which are routinely prescribed for everyday ailments such as fever, infections and gastric problems. Officials noted that the highest number of NSQ drugs were recorded in August last year.
According to CDSCO data, samples of medicines such as paracetamol–aceclofenac combinations, pantoprazole, rabeprazole, amoxycillin with potassium clavulanate and albendazole failed to meet prescribed quality parameters or were found to be misbranded. Such failures can affect drug efficacy and, in some cases, pose direct health risks to patients.
Health experts said the findings point to gaps in regulatory oversight and post-market surveillance, stressing that ensuring drug quality is a shared responsibility between central and state authorities. They underlined the need for regular inspections of manufacturing units, random batch testing, and swift corrective action when violations are detected.
“These are routine medicines for pain, fever and gastric problems. Any compromise in quality can seriously harm patients,” said Dr G Srinivas, assistant professor of clinical pharmacology at Nizam’s Institute of Medical Sciences (NIMS). “States cannot rely only on central alerts. Proactive monitoring at the local level is critical for the protection of patient safety.”
B Shivshankar Gupta, member of the Telangana Chemists & Druggists Association (TSCDA), said many drugs fail quality checks because manufacturers do not fully comply with CDSCO regulations, making strict enforcement by drug authorities essential. “While NSQ alerts are concerning, they also reflect an active surveillance system. Detection does not always mean widespread harm, but it does highlight the need to strengthen manufacturing practices and compliance.
Small and mid-sized manufacturers especially require closer technical guidance and stricter audits to prevent repeated quality lapses,” he added. Experts also stressed that timely recalls, transparency in public disclosures and coordination between drug regulators are essential to restore confidence and ensure that substandard medicines do not reach patients.
“All affected batches were recalled, and inspectors conducted field checks at pharmacies and health centres to ensure the drugs were removed from circulation. We also issued show-cause notices to the concerned manufacturers,” said a DCA official.
