Last Updated on January 6, 2025 by The Health Master
Extension the deadline
Download the notification, the link is given below: The Ministry of Health and Family Welfare (MoHFW) has issued a draft notification (vide notification No. GSR 10(E) dated 04-01-2025) regarding the extension the deadline for Small and Medium drug manufacturers to comply with the revised Schedule M of the Drugs Rules, 1945.
The said notification has been issued with consideration that consultation with Drugs Technical Advisory Board (DTAB) shall be held as per the provisions, the Central Government intends to amend the notification number G.S.R. 922(E) dated the 28th December, 2023.
The main purpose of the notification regarding the extension the deadline is to provide the manufacturers with extra time to upgrade their facilities according to the revised schedule M.
Key points of the notification:
- The original deadline for compliance was 27-12-2024 which has already expired.
- The Ministry of Health and Family Welfare has received many requests from various industry associations for extension the deadline.
- The new deadline for compliance is 31-12-2025 as per the above draft notification with the condition mentioned below.
- Small and Medium drug manufacturers who is having a turnover of ₹250 crore or less can apply for an extension the deadline These manufacturers have to submit an application to the Central Licensing Authority (CLA) along with a time frame plan for compliance in their facilities as per the revised schedule M.
- They have to submit their applications for an extension the deadline within three months of the publication of the said notification.
Who is Affected?
The notification is applicable for the small and medium drug manufacturers in India.
Notice to stakeholders
The notice states as under:
The draft notification is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that said draft notification will be taken into consideration on or after the expiry of a period of seven days from the date on which copy of the Official Gazette of India containing the draft notification is made available to the public.
Condition:
States as under:
In the said notification, in rule 6, in the Table, in column (2), in the entry against Small and Medium manufacturers, 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 of or 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 the plan of upgradation. For such manufacturers the timeline for implementation shall be extended till 31st December, 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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