Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-04012025-259923
EXTRAORDINARY
PART II-Section 3-Sub-section (i)
PUBLISHED BY AUTHORITY
No. 10]
NEW DELHI, SATURDAY, JANUARY 4, 2025/PAUSHA 14, 1946
139 GI/2025
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 4th January, 2025
G.S.R. 10(E).—Whereas the Drugs Rules, 1945, were amended and published as required under sub-section
(1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification
of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare)
number G.S.R. 922 (E), dated the 28th December,2023, published in the Gazette of India Extraordinary, Part II, Section
3, Sub-section (i) dated the 5th January, 2024.
Whereas, the timeline of twelve months was provided for implementation of the provisions in respect of small
and medium manufacturers having turnover of Rupees 250 crores or less which is expiring shortly.
And several representations have been received from various associations to extend this timeline to enable
small and medium scale manufactures to comply with the provisions of revised Schedule M.
Now, therefore, in exercise of the powers conferred by sections 12 and 13 of the Drugs and Cosmetics Act,
1940 (23 of 1940), with consideration that consultation with Drugs Technical Advisory Board 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 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.
Objections and suggestions which may be received from any person within the aforesaid period will be
considered by the Central Government. Objections and suggestions, if any, may be addressed to the Under Secretary
(Drugs), Ministry of Health and Family Welfare, Government of India, Room No.414 A, D Wing, Nirman Bhawan,
New Delhi - 110011 or e-mailed at drugsdiv-mohfw@nic.in;
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."
[F. No. X.11014/2/2017-DRS]
RAJIV WADHAWAN, Adviser (Cost).
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)
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.
SARVESH KUMAR SRI
Date: 2025.01.04 17:31:23+05:30