π Topic 02 of 6 Β· Chapter 07 Β· Health Technology & Pharmaceuticals
Generic Medicines & Drug Policy in India
Jan Aushadhi Scheme, NPPA, DPCO, TRIPS Section 3d β complete notes for UPSC & PSC exams.
π Generic vs Branded Medicines
| Feature | Generic Medicine | Branded Medicine |
|---|---|---|
| Active ingredient | Same as branded (bioequivalent) | Original formulation |
| Price | 60-90% cheaper | Expensive (includes R&D, marketing costs) |
| Efficacy | Same as branded | Original |
| Patent | No patent (expired or not applicable) | Under patent protection |
| Approval | Must prove bioequivalence | Full clinical trials required |
π Jan Aushadhi Scheme
- Full name: Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)
- Provides affordable generic medicines through Jan Aushadhi Kendras (stores)
- Over 10,000 Jan Aushadhi Kendras across India
- Medicines available at 50-90% less than branded medicines
- Implemented by BPPI (Bureau of Pharma PSUs of India) under Ministry of Chemicals and Fertilizers
π Drug Pricing Regulation
- NPPA (National Pharmaceutical Pricing Authority) β regulates drug prices
- DPCO (Drug Price Control Order) β controls prices of essential medicines
- NLEM (National List of Essential Medicines) β 384 medicines (2022) β prices regulated
- TRIPS Section 3(d) β India’s Patents Act β prevents “evergreening” of drug patents β requires genuine innovation for new patent
- Novartis vs India (2013) β Supreme Court upheld Section 3(d) β rejected Gleevec (cancer drug) patent
β Key Facts:
β’ Jan Aushadhi Scheme = PMBJP = 10,000+ kendras = 50-90% cheaper medicines
β’ NPPA = National Pharmaceutical Pricing Authority = regulates drug prices
β’ DPCO = Drug Price Control Order = controls essential medicine prices
β’ TRIPS Section 3(d) = prevents drug patent “evergreening”
β’ Novartis vs India (2013) = SC upheld Section 3(d) = affordable cancer drugs
β’ Jan Aushadhi Scheme = PMBJP = 10,000+ kendras = 50-90% cheaper medicines
β’ NPPA = National Pharmaceutical Pricing Authority = regulates drug prices
β’ DPCO = Drug Price Control Order = controls essential medicine prices
β’ TRIPS Section 3(d) = prevents drug patent “evergreening”
β’ Novartis vs India (2013) = SC upheld Section 3(d) = affordable cancer drugs