Revised Schedule M (G.S.R. 922(E)): what changed in India's GMP rules and the deadlines
| Document | Ministry of Health and Family Welfare notification G.S.R. 922(E), 28 December 2023 (Schedule M, Drugs Rules, 1945); extension: G.S.R. 127(E), 11 February 2025 ↗ |
|---|---|
| Issued by | Other |
| Issued | 28 Dec 2023 |
| Effective | 28 Dec 2023 |
In short: The Ministry of Health and Family Welfare (not CDSCO itself) replaced Schedule M of the Drugs Rules, 1945 through G.S.R. 922(E) dated 28 December 2023. The new Schedule is titled “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products”. Implementation was staged by company turnover.
What changed
The notification substitutes the whole of Schedule M. Part I (main principles of GMP) now contains, among other things, the following sections, each of which you can read in the Gazette text:
- Pharmaceutical Quality System (para 1): the manufacturer is responsible for quality; senior management is responsible for an adequately resourced PQS that incorporates GMP and Quality Risk Management.
- Quality Risk Management and product quality review (paras 2.1–2.3): QRM must be scientifically based and proportionate to risk. Product quality reviews cover all products including export-only products, are normally done annually, and must include at least the 12 items listed in 2.3.2 (starting materials, deviations, changes, stability monitoring, complaints and recalls, qualification status of equipment and utilities, technical agreements, and others).
- Qualification and validation (para 5): a validation master plan, DQ/IQ/OQ/PV, ongoing periodic review rather than one-off exercises, and particular attention to analytical method, automated system and cleaning validation.
- Stability (para 19.9): a written ongoing stability programme, and stability determined before marketing and after significant changes in process, equipment or packaging materials.
- Computerised systems (para 20): validation proportionate to complexity and criticality, access and audit-trail type controls (record of the data change, previous entry, who and when), a second check on critical manual entries, change control, and back-up.
- Other Part I headings include change control, complaints, recalls, contract manufacture and analysis, self-inspection, personnel, premises, equipment, materials, documentation, production and quality control.
- Later Parts cover sterile products, hazardous substances, biologicals, radiopharmaceuticals, phytopharmaceuticals and other product categories; the Site Master File is an appendix.
Who it affects
Licensed manufacturers of drugs under the Drugs Rules, 1945. Rule 6 of the notification sets the implementation timeline by turnover.
Key dates
- 28 December 2023: G.S.R. 922(E) published; the rules come into force on publication.
- Large manufacturers (turnover above INR 250 crore): six months from publication, i.e. about 28 June 2024 (our calculation from the official wording).
- Small and medium manufacturers (turnover INR 250 crore or less): twelve months from publication, i.e. about 28 December 2024 (our calculation).
- 11 February 2025, G.S.R. 127(E): small and medium manufacturers with turnover below INR 250 crore could apply on Form A to the Central Licence Approving Authority within three months of publication, with an upgradation plan, and the timeline for those manufacturers was extended to 31 December 2025.
That extension date has already passed (today is 16 October 2026).
What to do now
- Confirm which turnover category applies and that your licence is not relying on an expired extension.
- Run a gap analysis against Part I (PQS, QRM, PQR, validation, stability, computerised systems) and the Part relevant to your dosage form. (Example in-house approach: one tracker with clause, gap, owner, due date.)
- Make sure product quality reviews exist for every product, including export-only ones.
- Check that computerised systems used in GMP areas are validated and have change records and back-up.
Related reading: Good manufacturing practices for Pharmaceutical products, Validation Master Plan, SOP For Computerised System Introduction and Validation.