[Answered] Evaluate the effectiveness of India’s drug regulatory framework in controlling the proliferation of unapproved FDCs. Suggest reforms needed to strengthen the regulatory mechanisms.

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.

Effectiveness of India’s Drug Regulatory Framework

• Unapproved FDCs: India has faced challenges in regulating the market for FDCs, with concerns about the safety and efficacy of many combinations. Some FDCs entered the market without adequate scientific rationale or approval from regulatory authorities. Since FDCs are not covered under the Drugs (Prices Control) Order (DPCO) (which enables the government to fix the prices of individual drugs), manufacturing FDCs is a way to escape the ambit of the DPCO.
• 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.
• States’ inability to implement norms: State drug controllers continue to ignore legal provisions and issue manufacturing licenses for FDCs not approved by the Drugs Controller General of India (DCGI).

Reforms to Strengthen Regulatory Mechanisms

• Improved Approval Procedures: Delays can be avoided by streamlining and speeding up the FDC approval process while upholding strict scientific review. Ensuring that only combinations with demonstrated therapeutic benefits and safety profiles are permitted on the market requires the establishment of strong approval criteria.
• Boosting Post-Marketing Surveillance: To keep an eye on the effectiveness and safety of medications once they are on the market, a strong post-marketing surveillance system must be put in place. Manufacturing facilities can benefit from routine audits and inspections to help guarantee continuous adherence to quality standards.
• Regular Review and Update of Regulations: To stay up to date with evolving medical needs and scientific discoveries, regulations should be reviewed and updated regularly. The regulatory framework’s weaknesses and potential areas for improvement can be found through periodic assessments.

Conclusion

As pointed out in the study Ministry of Health needs to regulate FDCs, otherwise this unapproved FDC may end up contributing to the AMR problem in India. These reforms need to be implemented in a coordinated manner, involving collaboration between regulatory bodies, healthcare professionals, industry stakeholders, and the public to ensure the safety and efficacy of drugs in the Indian market.