Date: 2026-04-21Category: Extra OrdinaryState: Union GovernmentCountry: India
Draft Proposal for amendment under Rule 89 of Drugs Rules 1945, for obtaining licence under Form 29 for different categories falling under Form 25A, 25F, 28A, 28B, 28D, 28DA, 28E, 28F
**Executive Summary**
The Ministry of Health and Family Welfare issued a notification on April 21, 2026, proposing the "Drugs (...... Amendment) Rules, 2026," to amend the Drugs Rules, 1945. The draft rules seek to expand the scope of forms recognized under Rule 89 and are open for public comment for a period of 30 days. Once finalized, the rules will come into force three months after their publication in the Official Gazette.
**Key Points / Main Content**
**Administrative Provisions**
* **Draft Status:** These rules are currently in draft form and have been published for information and feedback from all persons likely to be affected.
* **Consultation:** The proposed changes were made in exercise of powers under the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board.
* **Timeline:** The Central Government will take the draft into consideration after 30 days from the date the Gazette copies are made available to the public.
**Proposed Amendments to Rule 89**
* **Expansion of Form References:** The amendment proposes to substitute the limited reference of “Form 25 or Form 28” with a more comprehensive list.
* **Updated Form List:** The new list of forms under Rule 89 will include: Form 25, Form 25A, Form 25F, Form 28, Form 28A, Form 28B, Form 28D, Form 28DA, and Form 28F.
**Impact Analysis**
**General Public and Affected Persons**
**Impact**
Individuals or entities likely to be affected by these changes have a defined window to influence the final regulations.
**Action Required**
Submit any objections or suggestions in writing to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, or via email to drugsdiv-mohfw@gov.in within 30 days.
**Central Government (Ministry of Health and Family Welfare)**
**Impact**
The government is obligated to review and consider all feedback received within the specified timeframe before finalizing the amendment.
**Action Required**
Review the received objections and suggestions to determine if revisions are necessary before the final 3-month implementation period begins.
**Drug Manufacturers and Licensees**
**Impact**
Regulated entities using the specified forms (25 and 28 series) will be subject to the updated requirements of Rule 89.
**Action Required**
Review the expanded list of forms to ensure future compliance with Rule 89 once the three-month implementation period following final publication concludes.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The parent legislation that grants the Central Government the power to make and amend rules for the regulation of drugs and cosmetics.
Drugs Rules, 1945: The primary regulatory framework being amended, specifically regarding Rule 89 and the update of various application forms.
Ministry of Health and Family Welfare: The central ministry responsible for the formulation and notification of these draft regulatory amendments.
Drugs Technical Advisory Board: The statutory advisory body consulted by the Central Government as a mandatory step in the process of amending drug rules.
Drugs (Amendment) Rules, 2026: The specific draft initiative proposed to update the documentation requirements and forms under the existing drug regulations.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-22042026-271969
CG-DxLxx-GEI-D2H20x4xx2 026-271969
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 275] नई दिल्ली, मगं लवार, अप्रलै 21, 2026/विै ाख 1, 1948
No. 275] NEW DELHI, TUESDAY, APRIL 21, 2026/VAISAKHA 1, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 21 अप्रलै , 2026
सा.का.जन. 299(अ).— औषजध जनयम, 1945 म ेंऔर संिोधन करने के जलए कुछ जनयमों का जनम्नजलजखत प्रारूप,
जिसे केंद्र सरकार औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा (1) और
धारा 33 की उप-धारा (1) द्वारा प्रित्त िजियों का प्रयोग करत े हुए, औषजध तकनीकी सलाहकार बोडड स े परामि ड के बाि
बनाना प्रस्ट्ताजवत करती ह,ै इसके द्वारा प्रभाजवत होने की संभावना वाले सभी व्यजियों की िानकारी के जलए एतद्द्वारा
प्रकाजित दकया िाता ह;ै और एतद्द्वारा नोरिस दिया िाता ह ैदक उि प्रारूप जनयमों को उस तारीख स ेतीस दिन की अवजध
समाप्त होन े पर या उसके बाि जवचारार्ड स्ट्वीकार कर जलया िाएगा जिस तारीख को इन प्रारूप जनयमों वाल े भारत के
रािपत्र की प्रजतयां िनता के जलए उपलब्ध कराई िाती ह।ैं
उि अवजध के भीतर दकसी भी व्यजि स े प्राप्त होन े वाली आपजत्तयों और सुझावों पर केंद्र सरकार द्वारा जवचार
दकया िाएगा।
आपजत्तयां और सुझाव, यदि कोई हों, अवर सजचव (औषजध जवजनयमन), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय,
भारत सरकार, य-ू 6, वकड हॉल- सी ववंग, पहली मंजिल, कतडव्य भवन-1, नई दिल्ली, 110001 को संबोजधत दकए िा सकत े
ह ैंया drugsdiv-mohfw@gov.in पर ईमले दकए िा सकत े ह।ैं
2820 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप जनयम
1. (i) इन जनयमों को औषजध (...... संिोधन) जनयम, 2026 कहा िाएगा।
(ii) ये रािपत्र म ेंअंजतम जनयमों के प्रकािन के 3 महीने बाि प्रवृत्त होंगे।
2. औषजध जनयम, 1945 में, जनयम 89 के अधीन, " प्ररूप 25 या प्ररूप 28 " िब्िों के स्ट्र्ान पर " प्ररूप 25 या प्ररूप
25ए या प्ररूप 25एफ या प्ररूप 28 या प्ररूप 28ए या प्ररूप 28बी या प्ररूप 28डी या प्ररूप 28डीए या प्ररूप 28एफ
" िब्ि प्रजतस्ट्र्ाजपत दकए िाएगं े।
[फा. स.ं एक्स.11014/03/2026-डीआर]
हष ड मंगला, संयुि सजचव
रिप्पणी: औषजध जनयम, 1945 रािपत्र म ें अजधसूचना संख्या एफ. 28-10/45-एच (1) दिनांक 21 दिसंबर, 1945 के
तहत प्रकाजित दकए गए र् े और अंजतम बार अजधसूचना संख्या सा.का.जन.… (अ), दिनांक.… के तहत संिोजधत दकए
गए र्े।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 21st April, 2026.
G.S.R. 299(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 Regulation),
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, 2026.
(ii) They shall come into force after the 3 months of publication of the final rules in the Official
Gazette.
2. In the Drugs Rules, 1945, under rule 89, the words “Form 25 or Form 28” shall be substituted
with the words “Form 25 or Form 25A or Form 25F or Form 28 or Form 28A or Form 28B or
Form 28D or Form 28DA or Form 28F”.
[F. No. X.11014/03/2026-DR]
HARSH MANGLA, Jt. Secy.
Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45-H
(1) dated 21st 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.