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Fixed-dose combinations in India - Addressing approval challenges
Express Pharma
|May 2025
At the Ahmedabad Pharma Summit 2025, Ganesh Boddu, GM-Regulatory Affairs & Clinical Research, Eris Life Sciences, delivered a session titled "Regulatory pathway for fixed-dose combinations (FDCs) in India – Addressing approval challenges."
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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.
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