Archive · 28 Jul 2025
India to Enforce Drug Quality Rules with States
India is making sure its drug companies follow good manufacturing rules, which is like making sure all the toys in a toy factory are safe and work right.
The government is asking states to check these rules.
Big companies already follow the rules, but smaller ones have more time to get ready.
These rules are important because they help keep medicines safe and good for people who take them.
It started after some problems with medicine quality, so now the government is stepping up inspections to make sure everything is safe.
DCGI to instruct states to identify and act against non-compliant drugmakers.
Good Manufacturing Practices (GMP) ensure product quality and patient safety.
Revised Schedule M aims to align India's standards with global benchmarks.
Large companies already implement GMP; smaller firms have a deadline.
Many small firms lack GMP certification and are now upgrading facilities.
- Who
- Drug Controller General of India (DCGI), state authorities, and drug manufacturers.
- What
- DCGI to enforce drug quality norms with the help of states.
- When
- Ongoing, with a deadline for smaller firms to comply with GMP.
- Where
- India, focusing on states with many small pharma companies.
- Why
- To ensure drug quality, patient safety, and align with global standards.
Enforcement Challenges
Industry Efforts
Compliance Concerns
Enforcement Challenges
Lack of resources and infrastructure hinder compliance, especially in smaller states.
Industry Efforts
MSME firms are actively working to upgrade facilities.
- GMP Purpose
- Ensure product quality and patient safety
- GMP Standard Revision
- Revised Schedule M of Drugs and Cosmetics Rules, 1945
- Estimated Indian Pharma Market Value (FY23-24)
- $50 billion
- Number of Indian Pharma Companies
- Around 10,000
- Global Rank (by Volume)
- 3rd
- Global Rank (by Value)
- 14th
