Archive · 30 Dec 2025
Govt May Extend Deadline for Pharma Manufacturing Rules
The Indian government might extend the deadline for small and medium-sized pharma companies to follow new manufacturing rules.
Many of these companies are struggling to upgrade their facilities due to money problems and unclear rules.
The government had already given them more time until December 2025, but now they might need even more time.
The companies say they need help with money and training.
The government has a plan to support some companies, but it's not enough.
The new rules focus on better production facilities and keeping good records.
Big companies had to follow the rules by June 2024, but smaller ones got more time.
75% of pharma units have not started upgrading their facilities due to practical issues and lack of clarity.
CDSCO granted an extension to MSMEs to comply with revised Schedule M guidelines by December 2025.
Pharma associations are asking for another extension until December 2026 for MSMEs to submit upgradation plans.
The cost to upgrade facilities ranges from Rs 2 crore to Rs 10 crore, with recurring costs for maintenance.
The government's support scheme (PTUAS) only covers 300 units, which is less than 10% of the affected companies.
- Who
- Indian pharma units, especially MSMEs, and the Central Drugs Standard Control Organisation (CDSCO)
- What
- Potential extension of the deadline for implementing revised Schedule M guidelines for pharma manufacturing
- When
- The original deadline for MSMEs was December 2024, which has been extended to December 2025. Further extension to December 2026 is being considered.
- Where
- India
- Why
- Due to weak compliance, practical issues, lack of clarity, and financial constraints faced by MSMEs in upgrading their manufacturing facilities.
- Percentage of units not started
- 75%
- Units applied for extension
- 1,700
- Pending upgradation work
- 20-30%
- Estimated cost to upgrade
- Rs 2 crore to Rs 10 crore
- PTUAS outlay
- Rs 300 crore for FY25 and FY26
- Number of units supported by PTUAS
- 300
- Deadline for large manufacturers
- June 2024
- Deadline for MSMEs
- December 2024 (extended to December 2025)