**Executive Summary**
This document is a notification from the Ministry of Health and Family Welfare regarding proposed amendments to the Drugs Rules, 1945, in accordance with the Drugs and Cosmetics Act, 1940. The draft rules are published for public information, and objections or suggestions can be submitted within 30 days of the Gazette's availability. The proposed amendment removes the word "Syrup" from Entry No. 7 under the "Class of Drugs" column in Schedule K, Serial No. 13.
**Key Points / Main Content**
* **Draft Rules:**
* The rules will be called the "Drugs (...... Amendment) Rules, 2025."
* These rules will come into force on the date of their publication in the Official Gazette.
* **Amendment to Drugs Rules, 1945:**
* In Schedule K, in Serial No. 13, under the column "Class of Drugs," in Entry No. 7, the word "Syrup" shall be omitted.
* **Public Consultation:**
* The draft rules are published for information of all persons likely to be affected.
* The central government will consider the draft rules after 30 days from when the Gazette is available to the public.
* Objections and suggestions must be submitted to the Under Secretary (Drugs), Ministry of Health and Family Welfare, New Delhi, or emailed to drugsdiv-mohfw@gov.in, within the specified period.
**Impact Analysis**
**Stakeholder:** Drug Manufacturers/Pharmaceutical Companies
* **Impact:** Changes to Schedule K may require adjustments to manufacturing processes, labeling, or classification of certain drug products.
* **Action Required:** Review the draft rules, assess the impact on their products, and submit objections or suggestions to the Ministry of Health and Family Welfare if necessary.
**Stakeholder:** Consumers/Patients
* **Impact:** May indirectly be affected by changes to drug classifications and availability.
* **Action Required:** No direct action required, but they may wish to stay informed and provide feedback through relevant patient advocacy groups or by submitting suggestions to the ministry.
**Stakeholder:** Regulatory Authorities (e.g., Drug Inspectors)
* **Impact:** Will need to enforce the amended rules once they come into effect.
* **Action Required:** Understand the changes to Schedule K and adjust inspection and enforcement procedures accordingly.
**Stakeholder:** Ministry of Health and Family Welfare
* **Impact:** Responsible for reviewing the feedback on draft rules, finalizing the amendments, and implementing the changes.
* **Action Required:** Publish the notification, accept, and analyse feedback, finalize changes, and oversee the implementation of the amended rules.
Key Entities Referenced
Drugs Rules, 1945: The principal set of rules being amended.
Drugs and Cosmetics Act, 1940: The Act that empowers the Central Government to make the amendments to the Drugs Rules.
Ministry of Health and Family Welfare: The ministry responsible for proposing the amendments to the Drugs Rules.
Drugs Technical Advisory Board: The body consulted before making the amendment to the Drugs Rules.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एलxx.x-GअID.-E3x0xx1 22025-268923
CG-DL-E-30122025-268923
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 841] नई दिल्ली, मगं लवार, दिसम्ब र 30, 2025/पौष 9, 1947 1947
No. 841] NEW DELHI, TUESDAY, DECEMBER 30, 2025/PAUSHA 9, 1947 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 29 दिसम्बर, 2025
सा.का.जन. 927(अ).––औषजध जनयम, 1945 म ें और संिोधन करन े वाल े जनम्नजलजखत जनयमों का प्रारूप, जिस े
केंद्रीय सरकार औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा (1) तथा धारा
33 की उप-धारा (1) द्वारा प्रित्त िजियों का प्रयोग करत े हुए, औषजध तकनीकी सलाहकार सजमजत स े परामि श के पश्चात्
बनाने का प्रस्ट्ताव करती ह,ै यह सूचना सभी संभाजवत प्रभाजवत व्यजियों की िानकारी हते ु प्रकाजित की िाती ह।ै यह भी
सूजचत दकया िाता ह ै दक रािपत्र की वह प्रजतया,ाँ जिनम ें य े प्रारूप जनयम प्रकाजित दकए गए ह,ैं िब िनसाधारण के जलए
उपलब्ध हो िाएंगी, उस जतजथ स े तीस दिनों की अवजध समाप्त होने पर इन प्रारूप जनयमों पर जवचार दकया िाएगा।
उपरोि अवजध के भीतर दकसी भी व्यजि स े प्राप्त आपजत्तयों और सुझावों पर केंद्रीय सरकार द्वारा जवचार दकया िाएगा।
आपजत्तयााँ और सुझाव, यदि कोई हों, तो इन्ह ें अवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत
सरकार, य-ू 6, वकश हॉल- सी ववंग, प्रथम तल, कतशव्य भवन-1, नई दिल्ली, 110001 को संबोजधत दकया िा सकता ह ै
अथवा ई-मेल के माध्यम स ेdrugsdiv-mohfw@gov.in पर भेिा िा सकता ह।ै
8806 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप जनयम
1. (i) इन जनयमों को औषजध (…… संिोधन) जनयम, 2025 कहा िाएगा।
(ii) ये जनयम रािपत्र म ें उनके प्रकािन की जतजथ स ेप्रभावी होंगे।
2. औषजध जनयम, 1945 म,ें अनुसूची ‘K’ म,ें क्र.स.ं 13 म,ें “औषजध की श्रणे ी” िीषशक के अंतगशत, प्रजवजि संख्या 7 म,ें
“Syrup,” िब्ि को हटा दिया िाएगा।
[फा. सं. एक्स.11014/11/2025-डीआर]
हष श मंगला, संयुि सजचव
रटप्पणी: मूल जनयम रािपत्र म ें अजधसूचना स.ं F. 28-10/45-H(1), दिनांक 21 दिसंबर, 1945 द्वारा प्रकाजित दकए गए
थ े तथा अंजतम बार संिोजधत अजधसूचना स.ं सा.का.जन. ----- (अ)., दिनांक …… द्वारा दकया गया था ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 29th December, 2025
G.S.R. 927(E).––The following draft of certain rules further to amend the Drugs Rules, 1945, which the
Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-
section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs
Technical Advisory Board is hereby published for information of all persons likely to be affected thereby, and notice
is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty
days from the date on which the copies of the Gazette of India containing these draft rules are made available to the
public.
Objections and suggestions which may be received from any person within the period specified above 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, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi,110001 or
emailed at drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2025.
(ii) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs Rules, 1945, in Schedule K, in the Serial No. 13, under the column “Class of Drugs”, in the Entry No.
7, the word “Syrup,” shall be omitted.
[F. No. X.11014/11/2025-DR]
HARSH MANGLA, Jt. Secy.
Note : The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1)
dated 21st the December, 1945 and last amended vide notification number G.S.R.…..(E), dated.……
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.