India Revised Schedule M Changes

The revised Schedule M (G.S.R. 922(E), 28 December 2023) replaced India's old GMP schedule outright. The old version was mostly about premises, materials and minimum equipment. The new one is built around a pharmaceutical quality system with risk management, which CDSCO itself links to the WHO GMP guidance (TRS series). It also grew from 8 Parts to 13 and tightened several specific limits. Large manufacturers have had to comply since 29 June 2024. Small and medium firms that applied for an extension had until 31 December 2025.

Legal basis and compliance dates

• In the CDSCO September 2024 consolidation of the Drugs Rules, Schedule M is marked "Subs. by G.S.R 922(E) dated 28.12.2023 (w.e.f. 28.12.2023)" ^[1]. It still applies under rules 71, 74, 76 and 78 ^[2].
• Turnover above Rs. 250 crore: compliance has applied since 29 June 2024 (PIB, 12 Aug 2025).
• Small and medium manufacturers: rule 6 of the Drugs (Amendment) Rules, 2023 gave them "Twelve months from the date of publication of these rules".
  • G.S.R. 127(E) of 11 February 2025 added a proviso. Firms with turnover under Rs. 250 crore could apply in Form A within three months, with an upgradation plan, and their deadline then became 31 December 2025 (G.S.R. 127(E)).
  • Form A requires a gap analysis by section and a plan starting on or before 31.03.2025.
  • Applications had to be filed online through the ONDLS portal; hard copies were not considered ^[3].
• I found no notification extending the deadline beyond 31 December 2025.

Structure: 8 Parts became 13

• Old Schedule M:
  • Part I, "GMP for premises and materials" ^[4].
  • Parts IA–IF covered sterile products, oral solids, oral liquids, topicals, metered-dose inhalers and APIs.
  • Part II covered plant and equipment ^[5][6][7].
• New Schedule M:
  • Part I is now "GMP for pharmaceutical products: main principles" ^[8].
  • Part II covers sterile products.
  • Five Parts have no counterpart in the old schedule:
    • Part III: hazardous substances (sex hormones, steroids, cytotoxics) ^[9]
    • Part IV: biological products ^[10]
    • Part V: radiopharmaceuticals ^[11]
    • Part VI: phytopharmaceuticals ^[12]
    • Part VII: investigational products for clinical trials ^[13]
  • Parts VIII–XII cover oral solids, oral liquids, topicals, metered-dose inhalers and APIs ^[14][15].
  • Part XIII covers plant and equipment ^[16].

New quality system requirements (Part I)

• Pharmaceutical Quality System:
  • Senior management has "the ultimate responsibility" for an effective quality system ^[8].
  • GMP covers the whole life cycle, from investigational products through technology transfer to discontinuation ^[17].
  • Deviations need root-cause analysis, and the effectiveness of corrective and preventive actions (CAPA) must be monitored ^[18].
  • Management reviews are required at least annually unless otherwise justified, and a quality manual is required ^[19].
• Quality Risk Management and Product Quality Review:
  • Product quality reviews cover all products, including export-only products, and are "normally" annual ^[19].
  • Each review covers at least 12 elements, including stability trends, dossier variations, post-marketing commitments, qualification status of HVAC, water and gas systems, and technical agreements ^[20].
• Qualification and validation: a validation master plan plus DQ/IQ/OQ/PQ. Validation "shall not be considered as one-off exercises" ^[21][22].
• Dedicated sections that are new:
  • change control ^[23]
  • self-inspection plus supplier audits and approval ^[24]
  • computerised systems, which "shall be validated" ^[25]
  • The old schedule only had brief controls for electronic records ^[26].
• Pharmacovigilance: para 6.11 says the licensee "shall have a pharmacovigilance system in place" for reporting adverse reactions to the licensing authorities ^[27]. A CDSCO circular of June 2026 directs compliance and says inspectors may verify it during routine inspections ^[28].
• Contract and loan-licence manufacturing: written contracts must set out each party's duties and how the authorised person releases batches ^[29].

Specific limits that changed

Item	Old Schedule M	Revised Schedule M
Grade D microbial limits	air 500, settle plates 100 (per 2 h) [30]	air 200 CFU/m³, settle plates 100 CFU per 4 h, plus alert and action limits [31]
Retained samples	active ingredient kept 3 months after expiry of the last batch made from it [32]	finished product kept at least 1 year after expiry; active starting materials 1 year beyond expiry of the finished product; other starting materials at least 2 years if stability allows [33]
Exclusive use of premises	carve-out for "units licensed prior to 11th December, 2001" [4]	the Note as printed has no such carve-out [8]

Related guidance and pending changes

• August 2024 CDSCO circular: asks all vaccine and sterile manufacturers to do a gap analysis against revised Schedule M and WHO TRS 1044 Annex 2 ^[34].
• 93rd DTAB meeting, 16 February 2026 (minutes). These are recommendations; I found no amending notification yet. The Board:
  • agreed to align the Grade A microbial limit with WHO TRS 1044 Annex II;
  • recommended keeping the pre-revision exemptions for medical gases, empty gelatin capsules and disinfectant fluids.

Approach: I compared Schedule M in CDSCO's September 2024 consolidation of the Drugs Rules with the 2016 consolidation, and checked CDSCO circulars. I also checked G.S.R. 127(E), the PIB release and the DTAB minutes on official government sites. I could not open the G.S.R. 922(E) gazette notice itself, so its commencement table is quoted as G.S.R. 127(E) cites it.