Archive · 30 Jul 2026
India Tightens Drug Quality Rules, Aims Biopharma Growth
India has made new rules for making medicines.
All drug makers must follow the WHO guidelines or they may have to close.
The government will also stop companies that don’t follow the rules from getting government contracts.
Prices for essential medicines can only go up 10% each year.
India still uses some drug parts from China, but it is making more parts inside the country.
The government wants to help Indian companies make more medicines and keep them safe and affordable.
India enforces revised Schedule M, requiring WHO‑GMP compliance or shutdown.
Non‑compliant firms barred from government tenders and must obtain NOCs for certain exports.
Prices of essential medicines capped at 10% annual rise, with trade‑margin caps under review.
30‑35% of drugs still rely on Chinese APIs; PLI scheme boosts domestic bulk production.
Focus on strengthening biopharma ecosystem, reducing import dependence, and tightening surveillance.
- Who
- Manoj Joshi, Secretary, Department of Pharmaceuticals
- What
- India is enforcing stricter drug quality standards and reviewing price controls
- When
- Revised Schedule M became mandatory on January 1, 2026; article published July 30, 2026
- Where
- India
- Why
- To restore confidence in pharmaceutical manufacturing, support biopharma growth, reduce import dependence, and manage medicine prices
- Revised Schedule M Effective Date
- January 1, 2026
- WHO-GMP Compliance Requirement
- Mandatory for all manufacturers
- Price Cap on Essential Medicines
- 10% annual increase
- Domestic API Production Share
- 60-65%
- Chinese API Dependence
- 30-35%