Of the 103 NSQ drug samples, 47 were identified by central drug laboratories, while 56 were tested at state drug laboratories
The Central Drugs Standard Control Organisation (CDSCO), in its February quality review, has flagged 103 drug samples as ‘Not of Standard Quality’ (NSQ) and identified a batch of Telma H (Telmisartan 40mg & Hydrochlorothiazide 12.5mg) as spurious. The drug, widely prescribed for hypertension, was sampled from West Bengal.
The health ministry stated that the identified spurious drug sample was “made by an unauthorized manufacturer using a brand name owned by another company,” and that an investigation is underway. The actual manufacturer, as per the label claim, has denied producing the impugned batch.
Of the 103 NSQ drug samples, 47 were identified by central drug laboratories, while 56 were tested at state drug laboratories. The list includes medications used for pain relief, hypertension, heart disease, stomach ulcers, and chronic conditions. Fixed drug combinations (FDCs), including syrups for cough, cold, and vitamin deficiencies, were also among the flagged drugs.
As reported by ET Healthworld, CDSCO routinely collects and tests drug samples from sales and distribution points to ensure compliance with Indian Pharmacopoeia (I.P.) standards. The spurious batch of Telma H was found to be non-compliant with I.P., raising concerns over counterfeit medicines circulating in the market.
An industry expert noted that spurious drugs are a serious threat to public health, as they may contain incorrect, contaminated, or inactive ingredients, rendering them ineffective and potentially harmful. Under Section 17-B of the Drugs and Cosmetics Act, 1940, a drug is deemed spurious if it is falsely manufactured under another brand’s name, is an imitation, or bears deceptive labelling.
The ET Healthworld report further highlighted that some of the NSQ drugs include Rabeprazole Tablets by Martin & Brown BioSciences, Paracetamol & Diclofenac Sodium Tablets by IG Pharma, and Telmisartan Tablets IP by Orison Pharma International. Meanwhile, state laboratories flagged Calcium & Vitamin D3 Tablets by Affy Parenterals Vill., Phenytoin Tablets by Jackson Laboratories, and Cloprostenol Injection by Monatt Biotech, among others.
The health ministry has assured strict action against unauthorised manufacturers and reinforced its commitment to regulatory vigilance. The CDSCO continues to monitor drug quality through regular surveillance and updates its list of flagged drugs every month to inform stakeholders and ensure patient safety.
