๐ Topic 02 of 6 ยท Chapter 07 ยท Health Technology & Pharmaceuticals
Generic Medicines & Drug Policy in India
Jan Aushadhi Scheme, NPPA, DPCO, TRIPS Section 3d โ complete notes for UPSC & PSC exams.
๐ 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 |
๐ 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
๐ Drug Pricing Regulation
- NPPA (National Pharmaceutical Pricing Authority) โ regulates drug prices
- DPCO (Drug Price Control Order) โ controls prices of essential medicines
- NLEM (National List of Essential Medicines) โ 384 medicines (2022) โ prices regulated
- TRIPS Section 3(d) โ India’s Patents Act โ prevents “evergreening” of drug patents โ requires genuine innovation for new patent
- Novartis vs India (2013) โ Supreme Court upheld Section 3(d) โ rejected Gleevec (cancer drug) patent
โญ Key Facts:
โข Jan Aushadhi Scheme = PMBJP = 10,000+ kendras = 50-90% cheaper medicines
โข NPPA = National Pharmaceutical Pricing Authority = regulates drug prices
โข DPCO = Drug Price Control Order = controls essential medicine prices
โข TRIPS Section 3(d) = prevents drug patent “evergreening”
โข Novartis vs India (2013) = SC upheld Section 3(d) = affordable cancer drugs
โข Jan Aushadhi Scheme = PMBJP = 10,000+ kendras = 50-90% cheaper medicines
โข NPPA = National Pharmaceutical Pricing Authority = regulates drug prices
โข DPCO = Drug Price Control Order = controls essential medicine prices
โข TRIPS Section 3(d) = prevents drug patent “evergreening”
โข Novartis vs India (2013) = SC upheld Section 3(d) = affordable cancer drugs