Regulatory Actions on Fixed Dose Combinations (FDCs) in India
India's drug regulator, the Drug Controller General of India (DCGI), has taken action against the manufacture and sale of 35 Fixed Dose Combinations (FDCs), citing concerns over patient safety and potential adverse reactions.
Background on FDCs
- FDCs are medicines that combine two or more drugs into a single dosage form.
- Commonly used FDCs are for conditions like pain relief, fever, hypertension, heart attack, and stroke.
- Examples of banned FDCs include:
- Dapagliflozin + Glimepiride + Metformin for diabetes.
- Cilnidipine + Metoprolol Succinate for hypertension.
- Dextromethorphan Hydrobromide + Phenylephrine Hydrochloride for cough and nasal congestion.
Issues with Safety and Approval
- The DCGI has expressed concerns that many FDCs have been approved without proper evaluation of their safety and efficacy under the NDCT Rules 2019 and Drugs & Cosmetics Act 1940.
- There is a viewpoint that such approvals compromise patient safety and could lead to adverse drug reactions.
Regulatory Measures
- The DCGI has directed state and union territory drug controllers to:
- Stop the manufacture and sale of the 35 identified FDCs.
- Review their approval process for such drugs and ensure compliance with legal provisions.
- Conduct investigations and take necessary actions as per NDCT Rules 2019.
State Licensing Authorities' Oversight
- Some manufacturers claimed to have valid licenses from State Licensing Authorities (SLAs).
- However, it was found that SLAs issued licenses without obtaining necessary approval from the DCGI, as required for ‘new drugs’.
