Government bans sale and manufacture of 35 fixed-dose combination drugs; full list here

By Admin

18 Apr, 2025

Government Bans 35 Fixed-Dose Combination Drugs: Here’s Why It Matters

In a significant move aimed at safeguarding public health, the Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulatory authority, has officially banned the manufacture and sale of 35 fixed-dose combination (FDC) drugs. These combinations, which include widely-used painkillers, nutritional supplements, fertility treatments, and anti-diabetic medications, were being sold without adequate scientific evaluation of their safety and efficacy.

What Are Fixed-Dose Combination (FDC) Drugs?

Fixed-dose combination drugs are pharmaceutical formulations that combine two or more active pharmaceutical ingredients (APIs) in a fixed ratio within a single dosage form. Often referred to as "cocktail medicines," they are intended to simplify treatment regimens. However, not all combinations are clinically justified. When such combinations are used without proper research or rationale, they can pose serious health risks due to adverse drug interactions or incorrect dosing.

Why the Ban?

The CDSCO’s decision was based on concerns over the irrational use of these FDCs. In a recent directive issued by the Drugs Controller General of India (DCGI), Dr. Rajeev Raghuvanshi, it was highlighted that several FDCs were being manufactured and marketed without prior approval under the New Drugs and Clinical Trials (NDCT) Rules, 2019. This violation compromises patient safety and increases the risk of harmful side effects.

For instance, one banned FDC includes glimepiride (1 mg) and metformin (500 mg)—both commonly used for managing diabetes. However, these two drugs have different mechanisms and optimal timing for administration. Glimepiride should ideally be taken before meals, while metformin is usually taken after food to reduce gastrointestinal side effects. Combining them into one tablet can reduce their effectiveness and heighten risks.

Examples of Banned Combinations

Some of the now-banned FDCs include:

• Nefopam Hydrochloride 30 mg + Paracetamol 325 mg tablets
  
  

• Cefixime IP 200 mg + Ofloxacin IP 200 mg + Lactic acid bacillus (60 million spores) tablets
  
  

• Various anti-diabetic combinations and fertility formulations
  
  

Expert Reaction

Dr. Deep Dutta, an endocrinologist and clinical researcher, welcomed the ban, stating, “Irrational combination of medicines correctly banned by CDSCO. Hope the order is implemented strictly. Need more awareness among doctors and patients. There should be some logic, scientific basis, proof of safety and efficacy before they are combined.”

What This Means for Doctors and Patients

This regulatory action emphasizes the need for a more cautious approach when it comes to prescribing or consuming combination drugs. Both healthcare providers and patients are urged to avoid self-medication and to be more vigilant about the ingredients and legitimacy of any combined drugs being used.

Final Thoughts

While fixed-dose combinations can offer convenience, their misuse or unchecked approval poses a serious threat to public health. The CDSCO’s step is a reminder that all medications must undergo rigorous scientific validation before reaching the market. This move not only highlights regulatory vigilance but also promotes a safer, more rational use of medicines in India.