India Bans 35 Fixed-Dose Combination Drugs for Safety Concerns

India bans 35 fixed-dose combination drugs due to safety concerns and lack of scientific validation.

Over 30 fixed-dose combination drugs, including those used for pain relief, nutrition, and diabetes treatment, will no longer be manufactured or sold following a directive from India’s top drug regulatory body—Central Drugs Standard Control Organization (CDSCO) (1^✔ ✔Trusted Source
Central Drugs Standard Control Organization (FDC Division)

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Fixed-dose combination drugs contain multiple active pharmaceutical ingredients in a single formulation. Often referred to as cocktail medicines, these combinations—such as Nefopam Hydrochloride with Paracetamol or Glimepiride with Metformin —are under scrutiny due to health risks associated with incorrect dosing and interactions between the ingredients.

Unfit Pairings in Diabetes and Pain Relief Drugs

One such example involves Glimepiride and Metformin, which require specific timing for effective action. Metformin is typically taken post-meal to prevent stomach discomfort, whereas Glimepiride is best consumed before meals to trigger insulin production. Simultaneous intake reduces their effectiveness and increases the risk of adverse effects.

The Central Drugs Standard Control Organization emphasized that several fixed-dose combinations had been authorized for production and sale without safety assessments or efficacy data, violating national pharmaceutical standards. The use of these drugs without scientific review raises concerns over patient safety and potential side effects.

List of Banned Fixed-Dose Combinations

Some commonly used drug combinations which were recently banned by CDSCO are:

• Tamsulosin Hydrochloride IP 0.4mg & Finasteride IP 5mg Tablet




• Bisoprolol Fumarate IP 5mg & Cilnidipine IP 10mg Tablets
• Glimepiride IP 1mg & Metformin Hydrochloride IP 500mg Tablet
• Glimepiride IP 2mg, Metformin Hydrochloride IP (Sustained Release) 500mg & Voglibose IP 0.3mg Tablet
• Nefopam Hydrochloride 30mg + Paracetamol 325mg Tablets
• Cefixime IP 200mg + Ofloxacin IP 200mg + Lactic Acid Bacillus 60 Million Spores Tablets

These combinations are no longer permitted for manufacturing or sale due to concerns regarding their rationality, safety profile, and lack of scientific validation.
Dr. Deep Dutta, a diabetes specialist, welcomed the move and highlighted the urgent need for awareness among doctors and patients. He stressed that combinations of medicines should be based on clinical logic and pharmacological science, not convenience. Proper testing and evidence of safety and efficacy must support such formulations.

In conclusion, the ban on 35 fixed-dose combination drugs by CDSCO reflects the growing need for rigorous safety and efficacy assessments in pharmaceutical formulations. This move aims to protect public health by eliminating unapproved, potentially harmful combinations and promoting safer, scientifically validated treatments for patients.