Worrisome Drug Quality Defects: 145 Medicines Labeled Unsafe for Use

In a startling update, 145 medications from reputable pharmaceutical companies have failed quality assessments, raising significant alarms regarding patient safety. Among these, 52 drugs were deemed substandard by the Central Drug Control Laboratory, while 93 failed evaluations from various state drug authorities.

These impacted medicines encompass commonly used therapies for blood pressure, infections, and allergies, jeopardizing the health of millions. A recent governmental report disclosed that 145 distinct drugs from prominent brands did not pass safety checks. Specifically, 52 drugs were marked as failing by the Central Drug Control Laboratory, whereas 93 were rejected by several state authorities.

Earlier this year, the central government classified these medications as “Not of Standard Quality” (NSQ), indicating that they do not meet the required standards. This list includes popular products, such as Glenmark Healthcare’s widely utilized blood pressure medication, Telma AM, and Alkem Healthcare’s Ondem 4 for nausea relief. Additionally, antibiotics for treating tonsillitis, bronchitis, throat and ear infections, allergy treatments, and cough syrups are also included.

Key Issues and Health Hazards

Several frequently prescribed drugs identified as “Not of Standard Quality” (NSQ) consist of:

1. Telma AM (Telmisartan & Amlodipine) – Blood Pressure Treatment

– Manufactured by: Glenmark Healthcare
– Problem: Failed dissolution testing, indicating potentially ineffective release of the active ingredient.
– Health Risk: Poor blood pressure management can lead to heart attacks, strokes, and kidney issues. Individuals dependent on this medication may face increased risks of severe health problems due to inadequate hypertension control.

2. Ondem 4 (Ondansetron) – Medication for Nausea

– Manufactured by: Alkem Healthcare
– Problem: Did not meet quality standards, risking its effectiveness.
– Health Risk: Primarily used to combat nausea and vomiting in patients receiving chemotherapy, surgery, or experiencing severe gastroenteritis. If ineffective, patients may suffer from dehydration, imbalanced electrolytes, and a heightened chance of hospitalization.

3. Cefuroxime Axetil Tablets – Antibiotic for Infections

– Manufactured by: Bengal Chemicals and Pharmaceuticals Ltd.
– Problem: Failed dissolution testing, hindering its proper absorption in the body.
– Health Risk: This antibiotic is essential for treating bacterial infections like bronchitis, tonsillitis, and urinary tract infections. If the medication does not dissolve adequately, infections might persist, leading to severe complications, antibiotic resistance, and prolonged illness.

Scope of the Issue

Many of these drugs were produced in major pharmaceutical centers including Gujarat (Vadodara, Ahmedabad), Himachal Pradesh (Baddi), Maharashtra (Tarapur), Uttarakhand (Roorkee, Haridwar), and Puducherry. In January 2025, random sampling by the Central Drugs Standard Control Organization (CDSCO) across various states validated these concerning results.

Furthermore, West Bengal’s drug regulatory authorities identified two crucial medicines failing quality tests: Telmisartan, used for heart patients, and Amoxicillin & Potassium Clavulanate, a widely prescribed antibiotic. These failures expose critical shortcomings in pharmaceutical quality assurance, putting public health at risk.

Consequences and Immediate Actions Required

The collapse of such vital medications could have dire repercussions for patients who rely on them for their health. Substandard drugs may lead to useless treatments, deteriorating health conditions, drug resistance, and in extreme cases, even death.

This situation underscores the urgent need for reforms in drug production and quality verification. Stricter compliance with safety regulations and consistent, transparent inspections are crucial to avert future occurrences. The health of millions rests on the integrity of the pharmaceutical sector— where compromise is not an option.