Drug Regulation in India
Why in News?
On March 24, 2026, the Drugs Controller General of India (DCGI) intensified surveillance against the unauthorized sale and promotion of GLP-1 receptor agonists (such as generic versions of Ozempic and Wegovy). Inspections across 49 entities, including online pharmacies and slimming clinics, revealed violations like improper prescriptions and misleading advertisements.
Key Features
- Core Legislation: Drug regulation is currently governed by the Drugs and Cosmetics Act, 1940, though it is set to be replaced by the more comprehensive Drugs, Medical Devices and Cosmetics Bill.
- Streamlined Clinical Research (2026): New NDCT (Amendment) Rules, 2026 have introduced a "Prior-Intimation" pathway, replacing mandatory test licences for non-commercial manufacturing. This is expected to save up to 90 days in the drug development cycle.
- Digital Compliance: All applications are being shifted to the SUGAM portal, making digital documentation and tracking mandatory for license holders.
- Harsher Penalties: The proposed new law introduces strict monetary fines—the greater of ₹15 lakh or three times the value of confiscated drugs—and up to life imprisonment for manufacturing spurious drugs that cause death.
- Focus on Medical Devices: Medical devices are now being treated as a distinct category from drugs, with a new Medical Devices Technical Advisory Board and risk-based classification systems.
- Quality Standards: Schedule M was recently revised to integrate WHO-Good Manufacturing Practices (GMP), with full compliance for small and medium manufacturers required by late 2025.
