Telma H, containing Telmisartan (40mg) and Hydrochlorothiazide (12.5mg), is used to control high blood pressure, especially in those with water retention or heart failure, reducing risks of heart attacks, strokes, and kidney issues
Published Mar 30, 2025 | 3:07 PM ⚊ Updated Mar 30, 2025 | 3:07 PM
Synopsis: The Central Drugs Standard Control Organization (CDSCO) has identified a batch of Telma H, a hypertension drug, as spurious. The batch (05240198) failed to meet Indian Pharmacopoeia (I.P.) quality standards. Telma H, used to control blood pressure, contains Telmisartan and Hydrochlorothiazide. The investigation is ongoing, but counterfeit drugs can be harmful and ineffective for patients.
A batch of Telma H, a drug used by people suffering from hypertension to control blood pressure, from a reputed pharmaceutical company in India, has been found to be spurious by the Central Drugs Standard Control Organization (CDSCO) in its latest report. The batch number 05240198 found to be spurious by the drug regulators.
The CDSCO stated that the drug “does not conform to I.P.,” meaning it fails to meet the quality standards set by the Indian Pharmacopoeia (I.P.). Spurious drugs are fake or counterfeit medicines that falsely claim to be genuine, often containing incorrect, contaminated, or no active ingredients, making them ineffective and potentially harmful to patients.
“The product is purported to be spurious; however, the same is subject to the outcome of the investigation,” said the CDSCO.
Telma H, which contains Telmisartan (40mg) & Hydrochlorothiazide (12.5mg), is prescribed for controlling high blood pressure, particularly in individuals prone to water retention or heart failure. Proper blood pressure control reduces the risk of heart attacks, strokes, and kidney problems.
“The actual manufacturer (as per the label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug,” stated the CDSCO in its alert.
Last month, Telma AM, by the same manufacturer, and the same category of medicine, but used for the purpose to blood circulation without affecting kidney function was found to be of Not of Standard Quality by CDSCO.
From Antibiotics to Gastrointestinal medications, The Central Drugs Standard Control Organization (CDSCO) has issued a nationwide alert after identifying 103 drugs as “Not of Standard Quality (NSQ)” during routine regulatory surveillance in February 2025. NSQ are the drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs.
This includes 47 drugs found by central laboratory, and 56 drugs found by the state laboratory.
These drugs failed to meet established parameters for quality, such as dissolution, assay, sterility, and weight uniformity, thereby classifying them as substandard. Although they are not counterfeit, such drugs can lead to diminished efficacy and potential health risks due to their compromised formulations.
The list includes critical medications for fever, blood pressure, infections, and chronic diseases, raising urgent concerns about patient safety.
Samples were collected from sales and distribution channels across India and tested in 27 central and state laboratories, including the Central Drug Laboratory (CDL) Kolkata, Regional Drug Testing Laboratory (RDTL) Guwahati, and Drugs Testing Laboratory Hyderabad.
The extensive testing process revealed that 103 drugs, comprising tablets, injections, syrups, and disinfectants from 47 manufacturers, failed to meet quality standards. The testing was carried out at both central and state laboratories.
Among the central laboratories, CDL Kolkata identified 27 products, including IV fluids and antibiotics, while RDTL Guwahati flagged 10 products, mainly diabetes drugs and antibiotics. CDTL Mumbai found six non-compliant products, including iron sucrose injections, while CDTL Indore identified two products, including levocetirizine tablets. RDTL Chandigarh and CDTL Hyderabad each detected a single product that did not meet quality standards.
At the state level, Drugs Testing Laboratory Thiruvananthapuram had the highest number of NSQ drug findings, with 22 products, followed by Puducherry with 13 products, including misbranded antibiotics. Telangana’s state laboratory detected 11 substandard drugs, primarily gastrointestinal medications. Other state laboratories in Kathua, Srinagar, Agartala, and Kolkata also reported non-compliant drugs, including spurious veterinary drugs and faulty diabetes medications.
Among the most commonly affected drug categories, fever and pain relief medications accounted for 15 products. These included a batch of Paracetamol Tablets IP 500 mg, which failed dissolution tests at Thiruvananthapuram, Diclofenac Sodium Tablets IP with enteric coating defects identified in Telangana, and Xorcid-O Suspension, which contained no active ingredients, flagged by the Kathua laboratory.
Blood pressure and heart medications were also affected, with 12 products failing quality checks. A batch of Telmisartan Tablets IP 40 mg did not meet dissolution standards in Guwahati, while Clopidogrel Tablets IP failed assay tests in Thiruvananthapuram.
The antibiotics and antifungals category had 18 problematic drugs, including Cefixime Oral Suspension IP, which exhibited phase separation and was flagged in Telangana, and Co-trimoxazole Tablets IP, which had dissolution issues identified in Guwahati.
Diabetes treatments also came under scrutiny, with 10 non-compliant products detected. A batch of Glimepiride + Metformin Tablets IP failed assay tests in Agartala. The gastrointestinal drug category saw 14 products identified as NSQ, including a batch of Rabeprazole Tablets IP 20 mg that failed dissolution tests at CDL Kolkata.
Nutritional supplements were another major category of concern, with 12 products flagged, including Vitamin B Complex Tablets that were found to have a crumbling texture during testing at Thiruvananthapuram.
(Edited by Ananya Rao)
