Last Updated on February 13, 2025 by The Health Master
Extension
The Government of India recently amended the drugs rules, and the same may be called the Drugs Amendment Rules 2025, bringing significant changes for small and medium-sized pharmaceutical manufacturers with respect to extension of the deadline for revised schedule M.
The government has issued a final notification vide GSR 127(E) dated 11-02-2025 reagrding the extension of the deadline for revised schedule M, and now the timeline has been extended till 31-12-2025.
The notification states as under:
In the Drugs (Amendment) Rules, 2023, in rule 6, in the Table, in the entry against ‘Small and Medium manufacturers’, under column (2) after the words “Twelve months from the date of publication of these rules”, the following proviso shall be inserted, namely :-
“Provided that the small and medium manufacturers with turnover less than two hundred and fifty crores may seek extension of the timeline for implementation and for that purpose shall make an application to the Central Licence Approving Authority in Form ‘A’ annexed to this notification, within a period of three months from the date of publication of this notification, along with a plan of upgradation and for such manufacturers, the timeline for Implementation shall be extended till the 31st day of December, 2025.”
Key Changes for Small & Medium Manufacturers:
Extended Timeline for Compliance:
A major highlight of these amendments is the extended timeline reharding the revised schedule M for compliance with the Drugs (Amendment) Rules, 2023.
(1) Eligibility: Small and medium manufacturers who have an annual turnover of less than two hundred and fifty crores (250 crores) can now apply for an extension.
(2) Application Process: To avail themselves of the benefits of this extension, manufacturers have to submit an application to the Central Licence Approving Authority within three months from the date of publication of these rules.
(3) Requirements: The manufacturers have to submit the application, including a detailed plan outlining a roadmap for upgrading their facilities to meet the requirements of revised schedule M.
(4) Extended Deadline: All the approved applicants will be eligible for the extended timeline for compliance as per revised schedule M, and this timeline will allow them to operate until December 31, 2025.
Who is eligible for the extended timeline for revised schedule M?
Small and medium manufacturers with an annual turnover of less than two hundred and fifty crores (250 crores) are eligible for the extended timeline for revised schedule M.
What is the process for applying for the extension for revised schedule M?
To avail themselves of the benefits of this extension, manufacturers have to submit an application to the Central Licence Approving Authority within three months from the date of publication of these rules.
What is the extended deadline for compliance for revised schedule M?
All the approved applicants will be eligible for the extended timeline for compliance as per revised schedule M, and this timeline will allow them to operate until December 31, 2025.
FORM A
Application for grant of extension of compliance with Revised GMP under Schedule-M of the Drugs Rules, 1945
| S. No. | Item | Details |
| 1. | Name and address of the manufacturer | |
| 2 | Turnover (year Apr 2023-Mar 24 ) | |
| 3 | Details of the licence in all forms, Licence no, Validity | |
| 3 | Sections held | |
| 4 | Whether holding WHO GMP/CoPP If yes, the validity of the certificate | |
| 5 | Details of gap analysis (section wise): Plant, Equipment, Lab equipment HVAC system, Utilities, Technical staff, Documentation Others | |
| 6 | Plan/strategy for compliance with the revised GMP (item wise as per the gap analysis at sl. No.5) Starting on or before 31.03.2025 | |
| 7. | Extension of time required for compliance (not beyond 1st Jan 2026) | |
| 8 | Justification of the time required for compliance |
Undertaking
I undertake that I have carried out the gap analysis and propose to initiate upgradation within three months from the date of this application and comply with the revised Schedule-M requirements as per the plan submitted at Sl. No. 6. above.
Date:
Place:
Signature
(Director/Partner/Proprietor/Authorised Signatory)
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