Schedule M Browser
Browse the full text of the Revised Schedule M (2025). We've organized the gazette notification into an indexed, searchable structure complete with plain English explanations for complex requirements.
Part I
General Requirements
Scope and Application
These rules shall apply to all premises used for the manufacture of drugs, including active pharmaceutical ingredients (APIs), finished pharmaceutical products (FPPs), and intermediates. Every manufacturer shall comply with the requirements of Good Manufacturing Practice as laid down in this Schedule.
AI Explanation
This rule applies to every facility where medicines are made — whether it's the raw ingredients (APIs), the final tablets/capsules (FPPs), or any step in between. All manufacturers must follow these GMP standards.
Definitions
In this Schedule, unless the context otherwise requires: (a) 'Good Manufacturing Practice' means that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. (b) 'Quality Assurance' means the sum total of the organized arrangements made with the object of ensuring that products are of the quality required for their intended use. (c) 'Quality Control' refers to sampling, specifications and testing, documentation and release procedures.
AI Explanation
This section defines key terms used throughout Schedule M. GMP is about making sure medicines are always made the same way to the right quality. QA is the big picture — all the systems in place. QC is the specific testing and checks.