Indian Economy·Policy Reforms
Pharmaceutical Industry — Policy Reforms
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Version 1Updated 5 Mar 2026
| Entry | Year | Description | Impact |
|---|---|---|---|
| Patents (Amendment) Act | 2005 | Introduced 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) | 2013 | Replaced 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. |