New Delhi, April 2025 – In its latest monthly quality review, the Central Drugs Standard Control Organisation (CDSCO) has declared 131 drugs samples and formulations as Not of Standard Quality (NSQ). Notably, the regulator has identified a batch of Telma 40, a widely used hypertension medication, as spurious.
Telma 40 Counterfeit Batch Found in West Bengal
CDSCO officials discovered a counterfeit batch of Telma 40 during raids across various locations. The Ministry of Health stated that the spurious drug sample came from West Bengal. An unauthorised entity had manufactured it using the brand name owned by another pharmaceutical company.
“The actual manufacturer named on the product label confirmed that they did not produce the impugned batch,” the CDSCO alert stated. The ministry added that an investigation is underway and appropriate action will be taken in accordance with regulatory provisions.
Understanding Spurious Drugs
Spurious drugs are fake or counterfeit medications that falsely present themselves as genuine. These drugs often contain incorrect, contaminated, or no active ingredients, posing serious health risks to patients. Such medicines can be ineffective or even dangerous, especially when used to treat critical conditions like hypertension or heart disease.
Breakdown of NSQ Drug Samples
Out of the 131 substandard drug samples, 70 were flagged by central drug laboratories and 61 by state laboratories. The NSQ list includes a range of commonly used formulations such as:
- Painkillers combining paracetamol with diclofenac and aceclofenac
- Fixed Drug Combinations (FDCs) for hypertension, heart disease, acidity, fever, and stomach ulcers
- Certain cough syrups and anti-allergy medications
Health Ministry Urges Caution, Not Panic
As reported by business-standard, the Ministry of Health clarified that the alert applies only to the specific batches tested and does not imply a wider concern regarding the safety or efficacy of all products in the market. “The failure is specific to the batch tested and should not raise alarm about other drug products,” the ministry noted.
Continuous Quality Surveillance in Place
As part of its ongoing regulatory vigilance, the CDSCO regularly collects samples from sales outlets and distribution points for laboratory testing. Each month, the organization publishes a list of NSQ and spurious drugs on its official portal, helping maintain transparency and public awareness about drug safety.