Published Mar 26, 2026 | 5:38 PM ⚊ Updated Mar 26, 2026 | 5:38 PM
Representational image. Credit: iStock
Synopsis: India’s February 2026 drug quality alert flagged 198 failed batches, with blood pressure medicines most affected. Telmisartan accounted for 13 failures across eight manufacturers, all failing dissolution tests. Such silent failures undermine hypertension control, threatening public health. Other alerts revealed contaminated, spurious, or ineffective medicines, showing systemic lapses in pharmaceutical quality and regulatory oversight.
A telmisartan tablet bought in Guwahati failed the same quality test as one purchased in Thiruvananthapuram. Between those two cities lies the length of India. 8 manufacturers, one drug category, 13 batches, one month.
The Central Drugs Standard Control Organisation’s February 2026 Not of Standard Quality (NSQ) alert listed 198 drug batches that failed laboratory testing.
Blood pressure medicines accounted for 18 of these, the largest single therapeutic category by failure volume. Every one of them failed on dissolution.
Dissolution testing measures whether a tablet releases its active ingredient at the rate required by pharmacopoeial standards. A tablet that fails dissolution may release too little drug, too slowly, or inconsistently.
“The patient swallows it, notices nothing unusual, and goes about their day. Their blood pressure, however, remains uncontrolled,” said Dr G Srinivas, a pharmacologist from Hyderabad.
Of the 18 failed batches, 13 involved telmisartan, a widely prescribed angiotensin receptor blocker used to manage hypertension by relaxing blood vessels and reducing the heart’s workload. The failures were not confined to a single company or region. Bennet Pharmaceuticals Ltd of Baddi recorded five failed batches reported by Assam’s state drug testing laboratory, while Swiss Garnier Life Sciences of Una recorded four failures flagged by Kerala laboratories.
Other manufacturers listed in the alert include Quality Pharma Production of Dibrugarh, Systole Remedies of Sirmour, Surge Pharmaceuticals of Pune, Super Formulations of Ujjain, Marc Lifesciences of Sikkim, and Signature Phytochemical Industries of Dehradun. The remaining five batches covered atenolol, enalapril, metoprolol, labetalol, and a telmisartan-hydrochlorothiazide combination, each from different manufacturers and each failing dissolution testing.
The geographic spread of these failures stretches from Assam in the northeast, through Odisha on the eastern coast, down to Chennai and across to Kerala, effectively covering a large portion of eastern and southern India. The pattern suggests that the issue is not localised but systemic, cutting across supply chains and regulatory jurisdictions.
For patients, dissolution failure represents a problem that cannot be seen or felt. Unlike adverse drug reactions, which may produce visible symptoms, substandard performance in dissolution leaves no immediate trace.
“When a drug batch is classified as not of standard quality, it does not necessarily mean it contains a harmful substance. It means it does not perform as required. A dissolution failure means the patient receives a dose, but not the dose the doctor prescribed,” Dr Srinivas explained.
For chronic conditions like hypertension, where patients take medication daily for years, this gap between expected and delivered dose becomes critical. “The medicine goes down, the day continues, and blood pressure stays elevated. Over time, this damages blood vessels, strains the heart, and increases the risk of stroke and kidney failure. The damage accumulates invisibly,” he said.
This makes dissolution failure particularly dangerous in public health terms. Patients continue treatment believing they are protected, while the underlying condition remains uncontrolled. The tablet looks identical, the packaging carries the same information, and there is no practical way for patients or doctors to detect the problem without laboratory testing.
India’s struggle with hypertension provides the context in which these findings gain significance. The country has an estimated 22 crore people living with high blood pressure, with prevalence at roughly one in three adults. Hypertension contributes to nearly one-third of all cardiovascular deaths.
Despite this, only 12 percent of patients manage to keep their blood pressure under control, according to data cited by the World Health Organisation and the ICMR-INDIAB study.
The gap between diagnosis and control reflects weaknesses at multiple levels. Awareness remains limited, particularly in rural areas where only about a quarter of patients know they have the condition. Access to diagnosis depends on the availability of healthcare facilities and functioning equipment. Treatment requires sustained access to medicines and follow-up care.
Each step in this chain filters out a portion of patients. For those who reach the final stage of treatment, the medicine itself becomes the last line of defence. If that medicine fails to perform as required, the entire system collapses at its most critical point.
While antihypertensive medicines formed the largest cluster of failures in the February alert, other findings reveal broader quality concerns across drug categories.
A batch of fenbendazole veterinary tablets manufactured by Chemino Pharma of Vapi showed no trace of the stated active ingredient but tested positive for tapentadol, a controlled opioid used in human medicine. The detected content of tapentadol was measured at 101.54 percent, raising serious questions about manufacturing controls and cross-contamination.
In another case, three batches of calcium with vitamin D3 suspension manufactured by JPEE Drugs of Haridwar contained no detectable vitamin D3 at all. Given the high prevalence of vitamin D deficiency in India, such products fail to deliver their intended therapeutic benefit.
A batch of amoxycillin and clavulanate oral suspension from Affy Parenterals of Baddi was found to lack clavulanic acid, a component essential to preventing bacterial resistance. Without it, the formulation effectively becomes amoxycillin alone, undermining its clinical purpose.
The alert also identified spurious products, including steroid creams that carried labels of manufacturers who later confirmed they had not produced those batches. Such products may contain incorrect or absent active ingredients, posing potential risks to consumers.
Cough and cold syrups, already under global scrutiny following contamination-linked deaths in 2022 and 2023, continue to feature in quality alerts.
Several batches of ambroxol, terbutaline, and guaiphenesin syrups failed assay testing, indicating that they contained lower amounts of active ingredients than stated on their labels. Other batches failed microbial contamination limits, including fungal count tests, suggesting lapses in manufacturing hygiene and quality control.
These findings indicate that quality concerns in the pharmaceutical sector are not confined to a single therapeutic area but extend across commonly used medicines, including those administered to vulnerable populations such as children.
