As of 31 December, 2025, the extended timeline for Micro, Small, and Medium Enterprises (MSMEs) to comply with Revised Schedule M standards has officially expired.
While the Principal Notification (G.S.R. 922(E)) set the technical standards, the implementation timeline was governed by the subsequent notification G.S.R. 127(E) (issued February 2025).
𝗞𝗲𝘆 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗙𝗮𝗰𝘁𝘀:
1. Deadline Expiry The conditional extension granting MSMEs until December 31, 2025, to upgrade their facilities has lapsed. From January 1, 2026, all manufacturing units, regardless of turnover, are expected to be fully compliant with the revised standards.
2. Condition for Extension (Retrospective) It is important to note that the extension under G.S.R. 127(E) was not automatic. Manufacturers were required to submit an 𝗨𝗽𝗴𝗿𝗮𝗱𝗮𝘁𝗶𝗼𝗻 𝗣𝗹𝗮𝗻 (𝗙𝗼𝗿𝗺 𝗔) to the State and Central Licensing Authorities by May 2025 to validly utilize the extension period up to December.
3. Current Status With the transition period over, regulatory focus is expected to shift towards verification of the upgrades proposed in the submitted plans. The standards emphasize Pharmaceutical Quality Systems (PQS), Quality Risk Management (QRM), and the validation of Computerised Systems (Clause 20).
Find Below ⬇️ the Links for Notifications Discussed above:
G.S.R. 922 (E): Link
G.S.R. 127 (E): Link
G.S.R. 666 (E): Link
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