[Answered] What are the key regulatory challenges in managing the proliferation of unapproved and potentially harmful FDC drugs in the Indian market?

Fixed-dose combination (FDC) refers to a pharmaceutical formulation that contains two or more active ingredients combined in a fixed ratio of doses within a single dosage form, such as a tablet or capsule. A recent study in the Journal of Pharmaceutical Policy and Practice documents that in the year 2020, 60.5% of FDCs of antibiotics were unapproved and another 9.9% were being sold despite being banned in the country.

Key regulatory challenges

• Compromises Drug Effectiveness: The combination of active or inactive ingredients in Fixed-Dose Combinations (FDCs) can interact, diminishing the therapeutic effectiveness of drugs or leading to the formation of toxic metabolites.
• Legal Liability Avoidance Tool: FDCs fall outside the purview of the Drugs (Prices Control) Order (DPCO), providing a means for manufacturers to avoid government-regulated pricing of individual drugs and potential legal liabilities.
• Production of Unjustified Combinations: Many FDCs lack a sound medical basis, featuring combinations such as anti-inflammatory drugs with vitamins or vitamins with analgesics.
• Absence of Quality Standards: Regulatory bodies have not established standardized testing protocols for the quality of these drugs, making it challenging to hold manufacturers accountable for substandard FDCs.
• Increased Drug Costs: Manufacturers may market a new FDC as a unique product addressing specific needs, allowing them to charge higher prices until competitors introduce similar products, leading to a subsequent reduction in prices.
• Weak Implementation of Licensing Norms: State drug controllers often neglect legal provisions and issue manufacturing licenses for FDCs not approved by the Drugs Controller General of India (DCGI).
• Legal Challenges Hampering Prohibition Orders: Ministry of Health prohibitions on specific FDCs face complex litigation and inconsistent court decisions.
• Contribution to Anti-Microbial Resistance (AMR): The unregulated use of FDCs adds to the Anti-Microbial Resistance issue in India.
• Regulatory Delays: Delays in the approval process and inadequate monitoring mechanisms have contributed to the proliferation of unapproved FDCs. The backlog of pending approvals and the slow pace of regulatory decisions have allowed some questionable combinations to remain in the market.

Conclusion

A comprehensive strategy that closes licensing norm loopholes strengthens regulatory capacity, clarifies legislative frameworks, improves post-marketing surveillance measures, and streamlines approval processes are needed to address these regulatory problems. International cooperation and coordination amongst regulatory bodies can also help to address the problem more skillfully.