Central Drugs Standard Control Organisation (CDSCO), apex drugs regulatory body, has directed all states and Union Territories to stop the manufacture, sale, and distribution of 35 unapproved FDC drugs.
- This decision has been taken as many FDC drugs were violating provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019 under the Drugs & Cosmetics Act 1940.
About Fixed-Dose Combination (FDC) Drugs
- FDC refers to products containing one or more active ingredients for a particular indication(s).
- Active Ingredient is the biologically active component of a drug product (tablet, capsule, cream, injectable) that produces the intended effects.
- FDCs are classified into 4 broad categories.
- FDCs are considered new drug (under NDCT) Rules, 2019) when it meets two conditions:
- It combines two or more drugs already approved for individual use in a fixed ratio.
- It alters the ratio of drugs in an already approved FDC, along with making changes to its claims.
Why FDC drugs are Preferred?
- Better Therapeutic Outcomes: Enhanced synergistic effects between combined drugs (when rationally selected).
- Improved Patient Compliance: Reduces the pill burden by combining multiple drugs into a single tablet or capsule.
- Reduced Cost of Therapy: Combined products may lower costs compared to purchasing multiple individual drugs.
