Ban on 35 Fixed-Dose Combination (FDC) Drugs – CDSCO

19.04.2025

Ban on 35 Fixed-Dose Combination (FDC) Drugs – CDSCO

Why in the news?                        

 India’s top drug regulator, CDSCO, has banned 35 medicines that combine two or more drugs in one tablet. These included painkillers, nutritional supplements, anti-diabetic, and fertility drugs. The ban was due to safety concerns and lack of proper medical reasoning behind these combinations.

Health Concerns:

• Wrong Combinations: Some drugs work best at different times (e.g., Glimepiride before meals and Metformin after meals), but when taken together, they can be less effective or cause harm.
• Risky Mixes: Some combinations may cancel each other’s effect or cause unwanted reactions.
• No Scientific Proof: Many of these fixed-dose medicines don’t have enough research to prove they are safe or helpful.

What are FDCs (Fixed-Dose Combination Drugs)

• Definition: Medicines that have two or more active ingredients in fixed amounts in one tablet or dose.
• Why They Are Used: To make treatment easier, reduce the number of pills, and save money.
• Common Uses: Diabetes, infections, pain relief, and long-term illnesses.

Role of CDSCO:

• Full Form: Central Drugs Standard Control Organization.
• Works Under: Ministry of Health and Family Welfare.
• Main Job: Approves new drugs, watches over clinical trials, and checks safety of critical medicines like vaccines and IV fluids.
• Law Behind It: Drugs and Cosmetics Act, 1940.

Why This Matters

• Safer Medicines: Helps doctors and patients use medicines that are proven and safe.
• Less Self-Medication: Stops people from using risky drug combos without advice.
• Better Regulation: Shows the government is serious about drug safety and quality.

What Should Be Done Next

• Improve systems to track side effects of medicines (pharmacovigilance).
• Educate doctors, pharmacists, and the public.
• Promote safer, well-tested medicine options.

                                  Source: The Hindu

Consider the following statement regarding to the Fixed-Dose Combination (FDC) Drugs:

1.They are pharmaceutical products that combine two or more active ingredients in a fixed ratio for treating specific medical conditions.

2.The active ingredient is the core biological component in a drug that is responsible for producing the intended therapeutic effect.

Which of the statements given above is/are correct?

A.1 only

B.2 only

C.Both 1 and 2

D.Neither 1 nor 2

Answer C