Indian Economy·Policy Reforms

Pharmaceutical Industry — Policy Reforms

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Version 1Updated 5 Mar 2026
EntryYearDescriptionImpact
Patents (Amendment) Act2005Introduced product patents for pharmaceuticals to comply with TRIPS agreement, ending the era of process patents that enabled easy reverse engineering of patented drugs.Transformed industry focus toward complex generics, biosimilars, and innovation while maintaining access through provisions like Section 3(d) preventing patent evergreening.
Drug Price Control Order (DPCO)2013Replaced DPCO 1995 with a new pricing mechanism based on market-based pricing for essential medicines listed in NLEM, covering 384 drug formulations.Balanced affordability with industry viability, reduced scope of price control while ensuring access to essential medicines through targeted intervention.
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