On April 11, 2025, India’s drug regulator classified 35 fixed-dose combination medicines as unapproved and ordered an immediate halt to their manufacture and sale, citing “grave risk to public health.” Fixed-dose combinations, or FDCs, mix two or more active drugs into a single formulation. Regulators said these products lacked scientific justification, proper clinical trials, or rational dosing.
Yet a field investigation across Indore, Dhar, Dewas and Ujjain found that many of these medicines were still being sold openly. Reporters documented their availability at more than 75 medical stores, including private pharmacies and government-run Jan Aushadhi centres. In several cases, pharmacists offered the medicines without prescriptions, sometimes arranging to procure them from outside the district when they were not immediately in stock.
The drugs were marketed as everyday remedies—for fever, diarrhea, cough, infections and diabetes—making them especially accessible to children, elderly patients and people managing chronic illness.
The Drug Combinations the Regulator Flagged
Among the medicines declared unapproved were several widely used combinations:
- Ofloxacin 50 mg + Ornidazole 125 mg + Racecadotril syrup, commonly given to children for diarrhea, despite experts warning that combining antibiotics with anti-secretory agents can lead to misuse and antibiotic resistance.
- Norfloxacin 125 mg + Metronidazole 120 mg + Simethicone, sold for stomach infections and bloating, a combination regulators said exposes patients to unnecessary antibiotics without clear clinical benefit.
- Cefixime 200 mg + Azithromycin 250 mg + Lactic Acid Bacillus, used for respiratory and gastrointestinal infections, despite concerns that mixing two powerful antibiotics encourages resistance and masks underlying illness.
- Phenylephrine + Chlorpheniramine + Paracetamol syrups, commonly given to children for cough and cold, combinations experts say can cause overdosing and cardiovascular side effects when used improperly.
- Metformin Hydrochloride + Glimepiride + Pioglitazone, prescribed for diabetes, which regulators warned could dangerously lower blood sugar levels if taken without close medical supervision.
According to the drug regulator, these combinations violate basic pharmacological principles by mixing drugs with overlapping or contradictory effects, without evidence that the combinations improve outcomes over single-drug therapy.
How the Ban Failed to Reach the Counter
Pharmacists interviewed during the investigation often acknowledged that the medicines had been questioned by authorities but said enforcement was inconsistent. Some claimed they were selling old stock. Others said distributors continued to supply the products, sometimes from outside the state.
In several documented cases, shopkeepers said they could arrange delivery of banned medicines within hours. “These drugs have been selling for 25 to 30 years,” one pharmacist said. “If they were really stopped, supply would have ended.”
Health officials cited weak enforcement as a key problem. While the Drugs Controller General of India issues national bans, inspections and prosecutions fall to state drug control departments, many of which are understaffed. Penalties for violations are often limited to fines, allowing illegal sales to continue as a cost of doing business.
The Risk to Patients—and the Cost of Inaction
Doctors and pharmacologists quoted in the investigation warned that the continued sale of unapproved combinations poses serious risks. Antibiotic-heavy FDCs can fuel drug resistance. Steroid-containing cough and cold medicines can suppress immunity in children. Diabetes combinations can cause sudden hypoglycemia, particularly in elderly patients.
Patients, experts noted, are rarely told that the medicines they are buying have been declared unsafe. The presence of these drugs at government-backed Jan Aushadhi centres further reinforces the perception that they are approved and safe.
Officials said action would be taken against violators and urged pharmacists to comply with the ban. But on the ground, the gap between regulatory orders and everyday practice remains stark.
For now, medicines deemed unsafe on paper continue to circulate freely—passed across pharmacy counters to unsuspecting patients, even as regulators warn that the consequences can be irreversible.
