Extension of Revised Schedule M – Announcement made on 12th Feb 2025
The Ministry of Health & Family Welfare has conditionally extended the due date for implementation of revised Schedule M (Good Manufacturing Practices provision) in respect of small and medium manufacturers having turnover of Rs. 250 crores or less, up to 31st December, 2025.
On 28th December, 2023, the Government of India had notified revised Schedule M requirements wherein “good manufacturing practices” was upgraded to “good manufacturing practices and requirements of plan and equipment for pharmaceutical products”. The category of manufacturers was divided into two; the first category was of large manufacturers having turnover more than 250 crores. A timeline of 6 months was given to such manufacturers for compliance. For small and medium manufacturers having turnover less than or equal to 250 crores, a timeline of 12 months was given for compliance. The revised Schedule M requirements have been implemented for large manufacturers w.e.f. 28th June, 2024.
Small and medium manufacturers had represented for extension of timeline to enable improvement in infrastructure, training of personnel and arranging financial resources. The same has been considered and the small and medium manufacturers have been given a time of 3 months from 11th February, 2025 to submit their plan for upgradation in Form A to the Central License Approving Authority. For such manufacturers who submit these details, the timeline of implementation would be extended till 31st December, 2025.
The revised Schedule M requirements are a positive step towards ensuring the quality and safety of pharmaceutical products being manufactured in India. The new regulations would enable the pharma companies to not only strengthen their domestic position but also become more competitive globally.
The extension is conditional and subject to submitting an upgradation plan.
Reasons for extension
- Small and medium manufacturers cited challenges in infrastructure upgrades, personnel training, and securing necessary financial resources.
How to apply for extension
- Submit an upgradation plan (Form A) to the Central License Approving Authority within three months from February 11, 2025.
- Applications must be submitted along with an upgrade plan.
Revised Schedule M requirements
- Upgraded “good manufacturing practices” to “good manufacturing practices and requirements of plan and equipment for pharmaceutical products”.
- Introduced product quality review (PQR), pharmaceutical quality system (PQS), quality risk management (QRM).
- Required qualification and validation of equipment, and computerised storage system for all products.
Previous deadline
Large manufacturers had six months to comply with the revised Schedule M requirements, and met the initial deadline of June 28, 2024.
Source :
CDSCO Gazette Notifications for Reference
2025.02.11 G.S.R. 127(E) Notification reg Extension of timeline for implementation of Schedule M
2025.01.06_G.S.R. 11(E)_Corrigendum to G.S.R 10(E) dated 04.01.2025 reg Extension of Schedule M
2025.01.04_G.S.R. 10(E)_ Notification for Extension of Schedule M
PIB Press Release :
https://pib.gov.in/PressReleaseIframePage.aspx?PRID=2102291#:~:text=The%20Ministry%20of%20Health%20%26%20Family,to%2031st%20December%2C%202025.
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