At the Ahmedabad Pharma Summit 2025, Ganesh Boddu, GMRegulatory Affairs & Clinical Research, Eris Life Sciences delivered a session titled “Regulatory pathway for fixed-dose combinations (FDCs) in India – Addressing approval challenges.” His presentation shed light on the complex regulatory landscape surrounding FDC approvals and provided strategic insights for navigating this domain.
Boddu outlined the role of key regulatory bodies such as the Central Drugs Standard Control Organization (CDSCO), Drugs Technical Advisory Board (DTAB), and Drugs Consultative Committee (DCC) in governing FDC approvals in India. He explained how FDCs are classified into four categories based on historical use, requirement of clinical trials, safety concerns, and irrationality — using real-world examples like Paracetamol + Ibuprofen and Ofloxacin + Ornidazole + Racecadotril to illustrate each category.
A major highlight of the session was his detailed explanation of the regulatory pathway for FDC approvals. He outlined the data requirements, which include CMC (Chemistry, Manufacturing, and Controls) data, preclinical studies, Phase III clinical trials, and bioequivalence or bioavailability studies. He stressed that the lack of robust scientific justification often leads to rejections by regulatory authorities.
Boddu shared several case studies where FDC proposals were rejected by the CDSCO due to reasons such as undefined dosing schedules, lack of clear therapeutic justification, insufficient published literature, and stability concerns. He also touched upon the recent Supreme Court interventions concerning irrational FDCs, citing the 2024 ban on combinations like Nimesulide + Paracetamol + Phenylephrine + Cetirizine. This highlighted the ongoing regulatory scrutiny and the judiciary’s growing role in ensuring patient safety. In conclusion, Boddu emphasised industry best practices for FDC approval, including the need for strong scientific rationale, clear alignment with CDSCO expectations, and robust post-marketing surveillance plans. He urged companies to build dossiers that preemptively address regulatory concerns to smoothen the approval process.