Published Sep 26, 2026 | 2:37 PM ⚊ Updated Sep 26, 2026 | 2:37 PM
CDSCO's NSQ section of the August alert contained 220 entries covering medicines, injections, medical devices and other products.
Synopsis: CDSCO’s August 2026 alert flags a batch of the commonly used blood pressure drug Telma AM as purportedly spurious after the labelled manufacturer denied producing it. The alert also lists 220 NSQ batches, including antibiotics, injections, Paracetamol, anaesthetic drugs and other medicines that failed prescribed quality tests.
India’s drug regulator flagged a commonly used blood pressure medicine, Telma AM, as a suspected “spurious” drug after the company named on the label told the authorities it had not manufactured the batch.
The finding appeared in the Central Drugs Standard Control Organisation’s (CDSCO) August 2026 drug quality alert, which separately listed 220 batches of medicines and other medical products as not of standard quality (NSQ).
Telma AM contains Telmisartan 40 mg and Amlodipine 5 mg, a combination used to control high blood pressure. The flagged batch was 18230791, manufactured in December 2023 and due to expire in November 2026.
CDSCO has listed both the manufacturer and manufacturing details as “under investigation.”
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CDSCO’s remark on the batch states: “The product is purported to be spurious. However, the same is subject to the outcome of the investigation.”
The regulator also said the manufacturing firm responded to its enquiry and informed CDSCO that the actual manufacturer named on the label had not produced the batch.
According to the alert, the firm told CDSCO that “they have not manufactured the impugned batch of the product and that it is a spurious drug.”
The finding did not, however, establish the manufacturer or how it had entered the supply chain. CDSCO has kept the manufacturer and manufacturing details under investigation.
The distinction gained significance because the Telma AM entry was not merely a finding that the medicine failed a particular laboratory quality test. The regulator questioned the product’s identity and origin.
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The August alert contained a separate finding involving Telma AM.
A Glenmark Pharmaceuticals batch, number 18240554, manufactured in July 2024 and expiring in June 2027, was reported by Delhi’s drug testing laboratory to have failed the assay test for the content of Telmisartan.
This was separate from the suspected spurious Telma AM batch. CDSCO identified the Glenmark product as an NSQ drug because of an assay failure, while the other Telma AM batch has been flagged as purportedly spurious.
The Telma AM finding raised a different concern from the routine quality failures in the NSQ list.
An NSQ finding could involve a medicine from an identified manufacturer failing a prescribed test such as dissolution, assay, sterility, description or uniformity of weight.
In the Telma AM case, CDSCO said the manufacturer named on the label denied making the batch, prompting the regulator to classify the product as purportedly spurious, pending the outcome of its investigation.
The available alert did not establish what the tablets contain, who manufactured them or how many units have entered the market.
Also Read: Telma 40 found fake again; manufacturer denies producing counterfeit batch
The separate NSQ section of the August alert contained 220 entries covering medicines, injections, medical devices and other products.
Failures ranged from dissolution and assay problems to defects involving sterility, identification, description, uniformity of weight, and other prescribed quality parameters.
Dissolution failures appeared repeatedly across the alert. They included several batches of Paracetamol, Telmisartan, Itraconazole and other medicines.
Among the findings, a batch of Telmisartan 40 mg manufactured by Swiss Garnier Life Sciences failed the dissolution test. A second batch from the same manufacturer also failed the dissolution test. Another Telmisartan batch manufactured by Kerala State Drugs and Pharmaceuticals was reported for a description defect.
Several other commonly used medicines also featured on the list, including Paracetamol, Montelukast, Levocetirizine, Rabeprazole, Amoxicillin and Clopidogrel.
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The alert also recorded several serious assay failures, where testing found that the amount of an active ingredient failed to meet the declared standard.
For example, a Metronidazole 400 mg batch from Inducare Pharmaceutical and Research Foundation reportedly contained only 32.44% of the stated Metronidazole content in one finding.
Other assay failures involved medicines including Vildagliptin, Pregabalin, Folic Acid and various combination drugs.
A batch of Calcium and Vitamin D3 tablets from SVR Healthcare, for instance, was reported to contain 179.15 IU of Vitamin D3 against a claimed 250 IU, and failed the dissolution test for calcium.
Also Read: CDSCO flags spurious batch of Telma 40
The August alert included several injectable medicines commonly used in hospitals, operating rooms, emergency departments and critical-care settings. A batch of Bupivacaine Hydrochloride in Dextrose Injection, used as a local anaesthetic to numb parts of the body during procedures and surgeries, failed pH and bacterial endotoxin tests. Themis Medicare manufactured the batch.
A Dexamethasone Sodium Phosphate injection, a corticosteroid commonly used to control inflammation and allergic reactions and in several hospital-based treatments, was also flagged. The batch, manufactured by Cotec Healthcare, failed tests for particulate matter and assay and also had a description-related defect.
A batch of Glycopyrrolate Injection, commonly used around anaesthesia and surgery to reduce secretions and manage certain effects associated with anaesthetic medicines, failed the sterility test. Jackson Laboratories manufactured the affected batch.
The list also included Haloperidol Injection, an antipsychotic medicine used in hospital settings for severe agitation and certain acute psychiatric symptoms. A batch failed the sterility test. Compound Sodium Lactate Injection, an intravenous fluid used for fluid and electrolyte replacement, had a batch that failed sterility and particulate-contamination tests.
Among the antibiotics, Amikacin Injection is used for serious bacterial infections, while Meropenem for Injection is a broad-spectrum antibiotic generally used in hospitals for serious infections. The Amikacin batch failed a particulate-matter test, while the Meropenem batch failed tests for solution clarity and particulate matter.
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Paracetamol was among the prominent names in the August alert.
Several batches of Paracetamol 500 mg and 650 mg tablets failed dissolution testing. The list included batches manufactured by Healer’s Lab, Rockbrook Overseas, Vivek Pharmaceuticals, Zenith Drugs and Tidal Laboratories.
Some Healer’s Lab batches also had physical defects. One batch reportedly failed dissolution and showed dark brown colour spots, which CDSCO described as a category B defect under its guidelines on NSQ drugs.
Many of the manufacturers named in the alert were located in pharmaceutical manufacturing clusters in Himachal Pradesh and Uttarakhand.
The entries included facilities in Baddi, Kala Amb, Nalagarh, Paonta Sahib and Solan in Himachal Pradesh, as well as Haridwar, Roorkee, Selaqui and Dehradun in Uttarakhand.
The presence of several manufacturers from those locations reflected their role as major pharmaceutical manufacturing centres. The CDSCO alert by itself did not establish that the geographic concentration represents a common cause or systemic problem across those facilities.
The list also included manufacturers from Telangana, Andhra Pradesh, Karnataka, Keralam, Tamil Nadu, Maharashtra, Gujarat, Madhya Pradesh, Uttar Pradesh, Sikkim and several other states.
Some manufacturers appeared repeatedly in the monthly alert.
Healer’s Lab Unit II appeared against multiple batches, including several Paracetamol batches that failed dissolution testing. Symbiosis Pharmaceuticals also appeared against several products, including Linezolid, Sitagliptin-Metformin and Cefpodoxime Proxetil.
The alert also recorded repeated findings against other manufacturers, reflecting the range of quality problems detected by state and central drug testing laboratories during the testing month.
(Edited by Majnu Babu).
