Telma H Drug Found Spurious in Latest CDSCO Alert

The Central Drug Standard Control Organization (CDSCO) has identified 47 medicine batches as Not of Standard Quality (NSQ) in its latest drug alert for February 2025. Among these, one batch of Telma H (Telmisartan 40mg & Hydrochlorothiazide 12.5mg), batch number 05240198, has been classified as spurious after failing critical quality tests.

Regulatory Surveillance and Drug Testing

CDSCO regularly monitors medicines available in the market by collecting random samples from sales and distribution points. These samples undergo testing in government laboratories. If any medicine batch fails to meet the required quality standards, the results are published on the CDSCO portal for public awareness.

Medicines Identified as Substandard

Some of the key medicines flagged as NSQ in February 2025 include:

Compound Sodium Lactate Injection IP – Manufactured by Eurolife Healthcare
Rabeprazole Tablets IP 20 mg – Manufactured by Martin and Brown BioSciences
Adrenaline Bitartrate Injection I.P. 1ml – Manufactured by Health Biotech
Co-trimoxazole Tablets I.P. – Manufactured by OMEGA PHARMA
Glimepiride Tablets I.P. 1mg – Manufactured by Karnataka Antibiotic and Pharmaceuticals
Nitrofurantoin Tablets IP 100mg – Manufactured by Jackson Laboratories
Amoxycillin and Clavulanate Potassium for Oral Suspension I.P. 3.6gm/30ml – Manufactured by Zee Laboratories

Spurious Drug Alert: Telma H

The batch of Telma H (Telmisartan 40mg & Hydrochlorothiazide 12.5mg) under batch number 05240198 failed critical quality tests. Manufactured in February 2024 with an expiry date of January 2027, it was found not conforming to the Indian Pharmacopoeia (IP) standards. The company listed as the manufacturer on the label has denied producing this batch, confirming it as a spurious drug.

Definition of Spurious Drugs

Under Section 17-B of the Drugs and Cosmetics Act, 1940, a drug is classified as spurious if:

It is falsely labeled as a product from a legitimate manufacturer.
It is an imitation or substitute for another drug in a misleading way.
The manufacturer mentioned on the label does not exist.
The product contains a different drug or substance than what is claimed.
It pretends to be a product of an authentic manufacturer but is not.

Reasons for Drug Sample Failures

The drugs flagged as NSQ did not meet quality standards due to issues such as:

Failure in assay (active ingredient content not meeting required levels).
Poor dissolution rate, affecting drug absorption in the body.
pH level discrepancies.
Presence of particulate matter.
Incorrect description (appearance, labeling errors, etc.).

Testing and Investigation

The flagged drug samples were tested in government laboratories across India, including:

Central Drug Laboratory (CDL), Kolkata
Regional Drug Testing Laboratory (RDTL), Guwahati
Central Drug Testing Laboratory (CDTL), Mumbai
Central Drug Testing Laboratory (CDTL), Indore
Central Drug Testing Laboratory (CDTL), Hyderabad
Regional Drug Testing Laboratory (RDTL), Chandigarh

Conclusion

The CDSCO’s monthly drug alerts help protect public health by ensuring substandard and spurious medicines are identified and removed from circulation. Stakeholders, including healthcare professionals and consumers, are advised to check CDSCO’s alerts and avoid using flagged medicines. Investigations into the spurious batch of Telma H are ongoing, and further action will be taken based on the findings.

Source: Inputs from various media Sources

I’m a pharmacist with a strong background in health sciences. I hold a BSc from Delhi University and a pharmacy degree from PDM University. I write articles and daily health news while interviewing doctors to bring you the latest insights. In my free time, you’ll find me at the gym or lost in a sci-fi novel.