CDSCO Bans 35 Fixed-Dose Combination (FDC) Drugs

1. The Central Drugs Standard Control Organisation (CDSCO), India's top regulatory body for pharmaceuticals, has recently issued a directive banning 35 unapproved FDC drugs across all states and Union Territories.
2. This move comes after it was found that several FDC formulations were in violation of the New Drugs and Clinical Trials (NDCT) Rules, 2019, framed under the Drugs and Cosmetics Act, 1940.

What are Fixed-Dose Combination (FDC) Drugs?

1. FDCs 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.

Classification of FDCs

1. FDCs are grouped into four broad categories based on their composition and therapeutic use.
2. These combinations are carefully assessed for safety, efficacy, and rationality before approval.

When is an FDC Considered a 'New Drug'?

Under the NDCT Rules, 2019, an FDC is classified as a new drug if:

1. It combines two or more drugs, each already approved for individual use, into a fixed ratio formulation.
2. It involves a change in the ratio of components in an already approved FDC, coupled with new therapeutic claims or indications.

Why Are FDCs Commonly Used?

1. Better Therapeutic Effectiveness: Rationally chosen drug combinations often lead to enhanced clinical outcomes due to synergistic action.
2. Improved Patient Compliance: Combining multiple drugs into one formulation reduces the pill burden and simplifies treatment regimens.
3. Cost Efficiency: FDCs can be cheaper than buying individual medicines, thus making therapy more affordable for patients.