According to the CDSCO, the flagged samples were collected by a Drugs Inspector in Bihar as part of regular market surveillance.
Published Jun 22, 2025 | 1:55 PM ⚊ Updated Jun 25, 2025 | 6:38 PM
Telma 40.
Synopsis: The Central Drugs Standard Control Organisation flagged two spurious batches of the widely prescribed blood pressure medication Telma 40 in its May 2025 quality surveillance report. The drug is commonly used to treat hypertension and reduce cardiovascular risk.
In a troubling reminder of India’s persistent challenge with counterfeit medicines, the Central Drugs Standard Control Organisation (CDSCO) flagged two spurious batches of the widely prescribed blood pressure medication Telma 40 in its May 2025 quality surveillance report.
The drug, which contains the active ingredient Telmisartan, is manufactured by a reputed Indian pharmaceutical company and is commonly used to treat hypertension and reduce cardiovascular risk.
However, batch numbers 05240226 and K18230707 of Telmisartan Tablets IP (40 mg) — marketed as Telma 40 — failed routine quality checks and have been deemed spurious.
According to the CDSCO, the flagged samples were collected by a Drugs Inspector in Bihar as part of regular market surveillance. The manufacturer listed on the product labels has formally denied producing these batches.
“The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug,” the CDSCO stated.
Batch 05240226, with a manufacturing date of February 2024 and expiry in January 2027, failed dissolution testing, a key measure of how well a drug releases its active ingredient in the body.
Meanwhile, batch K18230707 (manufactured in June 2024, expiring in May 2027) failed both identification and assay tests, suggesting the presence of incorrect or insufficient amounts of Telmisartan.
This is not the first time Telma 40 has come under scrutiny. In April 2025, the CDSCO had flagged another batch — 5240226 — in its March quality alert. That batch was also found to be spurious and non-compliant with the standards laid out in the Indian Pharmacopoeia (IP).
“The product is purported to be spurious; however, the same is subject to the outcome of the investigation,” the CDSCO noted in its report.
The manufacturer again denied any involvement in producing that batch, reinforcing suspicions about counterfeit drugs circulating under the brand name Telma.
In March 2025, a separate formulation — Telma H, a combination of Telmisartan (40 mg) and Hydrochlorothiazide (12.5 mg) — was also flagged as spurious by the CDSCO. Batch 05240198 (manufactured in Feb 2024, expiry on Jan 2027) was declared fake following similar discrepancies during testing.
While Telma 40 contains only Telmisartan, Telma H adds Hydrochlorothiazide, a diuretic that helps reduce fluid retention. Both are used to manage high blood pressure, but Telma H is typically prescribed for patients who also require fluid management, such as those with heart failure.
The CDSCO conducts routine drug surveillance by collecting samples from across distribution points. Spurious drug alerts are published monthly on its portal to warn stakeholders and protect public health.
“The purpose of displaying the spurious drugs list is to make stakeholders aware of the spurious drug batches identified in the market,” the CDSCO said.
Fake medicines pose serious health risks, especially for chronic conditions like hypertension. Patients relying on ineffective or contaminated blood pressure medications could suffer from uncontrolled hypertension, increasing their risk of heart attack, stroke, or kidney damage.
Under Section 17-B of the Drugs and Cosmetics Act, 1940, a drug is deemed spurious if:
The CDSCO emphasised that while the batches are “purported to be spurious,” final confirmation is pending further investigation. Authorities are now likely to probe supply chains, distribution networks, and other stakeholders to trace the source of these counterfeit products.
Flagged batches:
Telma 40:
Telma H:
(Edited by Muhammed Fazil.)
