Context: In a major crackdown on drug safety violations, India’s Central Drugs Standard Control Organisation (CDSCO) has banned 35 fixed-dose combination (FDC) drugs.

Meaning of the context: The April 11 order directs an immediate halt on manufacturing, sale, and distribution of these drugs, citing that they were approved without mandatory safety and efficacy evaluations under the New Drugs and Clinical Trials (NDCT) Rules, 2019. State drug regulators had approved them without following central oversight procedures.

Learning Zone:

• Fixed-Dose Combination (FDC) Drugs are medications that combine two or more active pharmaceutical ingredients (APIs) in a fixed ratio within a single dosage form (e.g., tablet, injection).
• FDCs classified as “New Drugs” require central approval for safety and efficacy, per NDCT Rules, 2019. Only CDSCO, not State Licensing Authorities (SLAs), can approve new FDCs.

Advantages of FDCs

• Improved Compliance: Fewer pills mean better adherence to therapy.
• Synergistic Action: Combining drugs with complementary actions can enhance efficacy.
• Cost-Effective: Reduces overall cost of treatment by lowering packaging and distribution costs.
• Prevents Resistance: Especially in TB/HIV treatment, combining drugs reduces chance of microbial resistance.

Concerns and Risks

• Irrational Combinations: Some FDCs (e.g., antibiotics + probiotics) lack scientific validation, contributing to antimicrobial resistance (AMR), a global health threat.
• Increased Adverse Effects: Multiple active ingredients raise the risk of drug interactions and side effects.
• No Individualized Dosage: Fixed ratios may not suit all patients.
• Regulatory Loopholes: Some manufacturers market FDCs without proper Central Drug Authority approval under state-level licenses.

Source : Business Today