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| Indicator | India (2023–24) | Comparator |
| GERD (% of GDP) | 0.7% | China: 2.7%, USA: 3.4%, Israel: 5.4% |
| Govt share of R&D | 55% | OECD Avg: 25% |
| Private sector share | 45% | OECD Avg: 75% |
| Researchers per million | 262 | Global Avg: 1,341 |
| No. of publications (Scopus, 2024) | 2.75 lakh | USA: 7.1 lakh |
| Patent filings (WIPO, 2024) | 83,000 | China: 17 lakh |
| Global Innovation Index (2024) | Rank 40 | China: 12, USA: 3 |
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| Regulatory Body | Jurisdiction | Key Issues |
| CDSCO (Central Drugs Standard Control Organisation) | Large manufacturers, export approvals | Limited manpower (only ~1,800 officers nationwide) |
| State Drug Control Authorities | SMEs, retail distribution | Weak enforcement, fragmented coordination |
| Pharmacovigilance Programme of India (PvPI) | Adverse drug reaction reporting | Poor coverage for paediatric drugs |
| FSSAI (in OTC products) | Monitors nutraceutical syrups | Overlaps and confusion in jurisdiction |
India has 10,500 licensed drug manufacturers, of which 70% are small-scale, often outside rigorous central oversight.
| Country/Region | Key Law/Policy | Key Provisions |
| United States | Best Pharmaceuticals for Children Act (BPCA), 2002 | Research incentives, FDA-mandated paediatric studies |
| European Union | Paediatric Use Marketing Authorisation (PUMA) | Requires paediatric investigation plans before approval |
| WHO (Global) | Essential Medicines List for Children (EMLc) | Defines safe, age-appropriate essential drugs |
Contrast: India lacks a dedicated paediatric drug act, relying only on CDSCO advisories.
Even the National List of Essential Medicines (NLEM 2022) updates adult formulations frequently, but the EMLc (India) remains under-reviewed since 2011.
| Indicator | India (2025) | Comparator |
| Drug inspectors | ~3,000 nationwide | Needed: 12,000 (Mashelkar Committee, 2003) |
| Manufacturing units | 10,500 | 70% uninspected in last 3 years |
| Pharmacovigilance centers | 650 (PvPI data, 2024) | Only 10% linked to child drug data |
| Testing labs | 50 (Central + State) | Only 18 accredited to WHO-GMP |
| Export value of formulations | $28.4 billion (FY2024–25) | 45% to Global South markets |