Date: 2026-08-07Category: Extra OrdinaryState: Union GovernmentCountry: India
Notification 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 has issued the Drugs (Twelfth Amendment) Rules, 2026, to further amend the Drugs Rules, 1945. This notification expands the scope of Rule 89 by incorporating a wider range of prescribed forms for regulatory compliance. The rules were finalized following a public consultation period initiated in April 2026 and came into force on August 7, 2026.
**Key Points / Main Content**
**Title and Commencement**
* The amendment is officially titled the Drugs (Twelfth Amendment) Rules, 2026.
* The rules became effective on the date of their publication in the Official Gazette (August 7, 2026).
**Amendment to Rule 89**
* The amendment specifically modifies Rule 89 of the Drugs Rules, 1945.
* The previous reference to "Form 25 or Form 28" has been substituted with a more comprehensive list of forms.
* The updated rule now includes: Form 25, Form 25A, Form 25F, Form 28, Form 28A, Form 28B, Form 28D, Form 28DA, Form 28E, and Form 28F.
**Regulatory Process and Consultation**
* The draft rules were previously published under G.S.R. 299(E) on April 21, 2026, for public feedback.
* The Central Government considered all objections and suggestions received within the 30-day window following the draft's public release on April 22, 2026.
* The final rules were made in consultation with the Drugs Technical Advisory Board (DTAB).
**Impact Analysis**
**Stakeholder: Pharmaceutical Manufacturers and Licensees**
**Impact**
Manufacturers are now subject to a more granular set of form requirements under Rule 89. The expansion from two forms to ten suggests more specific documentation requirements based on the nature of the drug or license type.
**Action Required**
Entities must identify which of the newly specified forms (such as 25A, 25F, 28A-F) apply to their specific operations and ensure all future filings and documentation align with the amended Rule 89.
**Stakeholder: Regulatory Authorities (Drugs Control Departments)**
**Impact**
Administrative and inspection frameworks must be updated to recognize and process the expanded list of forms cited in the amended rule.
**Action Required**
Regulatory officers must transition to the new form requirements for licensing, renewals, and compliance monitoring effective immediately from the date of gazette publication.
Key Entities Referenced
Drugs (Twelfth Amendment) Rules, 2026: The specific policy document introduced to amend Rule 89 of the existing drug regulations to include a wider range of prescribed forms.
Drugs Rules, 1945: The principal regulatory framework being amended, which governs the manufacture, sale, and distribution of drugs in India.
Drugs and Cosmetics Act, 1940: The parent legislation that provides the legal authority for the Central Government to create and amend rules related to drugs and cosmetics.
Drugs Technical Advisory Board: The statutory body consulted by the Central Government to provide technical guidance on the proposed amendments to the drug rules.
Ministry of Health and Family Welfare: The primary government regulator responsible for issuing these rules and overseeing the Department of Health and Family Welfare.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-08082026-275299
xxxGIDHxxx
CG-DLxx-ExG-I0D8E0x8x2x0 26-275299
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 649] नई दिल्ली, िुक्रवार, अगस्ट्त 7, 2026/श्रावण 16, 1948
No. 649] NEW DELHI, FRIDAY, AUGUST 7, 2026/SHRAVAN 16, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 6 अगस्ट्त, 2026
सा.का.जन. 713(अ).—औषध जनयम, 1945 का और संिोधन करन े के जलए कजतपय जनयमों का एक प्रारूप,
औषध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा (1) और धारा 33 की उप-धारा
(1) के अधीन यथा अपेजित, भारत सरकार के स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण
जवभाग) की अजधसूचना संख्या सा.का.जन. 299(अ), तारीख 21 अप्रलै , 2026 द्वारा भारत के रािपत्र, असाधारण, भाग
II, खण्ड 3, उप-खण्ड (i) में प्रकाजित दकया गया था, जिसम ें उन व्यजियों स,े जिनके इससे प्रभाजवत होने की संभावना थी,
उस तारीख स,े जिसको उि अजधसूचना वाल े रािपत्र की प्रजतया ं िनता को उपलब्ध कराई गई थीं, तीस दिन की अवजध
की समाजि स े पूवव आपजियां और सुझाव आमंजत्रत दकए गए थ;े
और, उि रािपत्र की प्रजतयां 22 अप्रलै , 2026 को िनता को उपलब्ध कराई गई थीं;
और केंद्रीय सरकार द्वारा, उि प्रारूप जनयमों पर िनता स े प्राि आपजियों और सुझावों पर जवचार कर जलया
गया ह;ै
अतः, अब, केंद्रीय सरकार उि अजधजनयम की धारा 12 और धारा 33 द्वारा प्रिि िजियों का प्रयोग करत े हुए, औषध
तकनीकी सलाहकार बोडव के परामि व के पश्चात, औषध जनयम, 1945 का और संिोधन करने के जलए जनम्नजलजखत जनयम
बनाती ह,ै अथावत:् —
6122 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
1. (1) इन जनयमों का संजिि नाम औषध (बारहवां संिोधन) जनयम, 2026 ह।ै
(2) य े रािपत्र म ें उनके प्रकािन की तारीख को प्रवृि होंगे।
2. औषध जनयम, 1945 का, जनयम 89 म,ें "प्ररूप 25 या प्ररूप 28" िब्िों और अंकों के स्ट्थान पर "प्ररूप 25 या प्ररूप
25क या प्ररूप 25च या प्ररूप 28 या प्ररूप 28क या प्ररूप 28ख या प्ररूप 28घ या प्ररूप 28घक या 28ङ या प्ररूप 28च"
िब्ि, अंक और अिर रख े िाएंगे।
[फा. स. ं X.11014/03/2026-DR]
हष व मंगला, संयुि सजचव
रिप्पण: औषध जनयम, 1945 का रािपत्र म ें अजधसूचना सख्ं या फा. 28-10/45एच (1), तारीख 21 दिसंबर, 1945 द्वारा
प्रकाजित दकए गए थ े और अंजतम बार अजधसूचना संख्या सा.का.जन. 706 (अ), तारीख 30 िुलाई, 2026 द्वारा संिोजधत
दकए गए थे।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 6th August, 2026
G.S.R. 713(E).—Whereas a draft of certain rules further to amend the Drugs Rules, 1945 was 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. 299(E), dated the 21st April, 2026, in the Gazette of India,
Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected
thereby, before the expiry of a period of thirty days from the date on which the copies of the Gazette containing the
said notification were made available to the public;
And whereas, copies of the said Gazette were made available to the public on the 22nd April, 2026;
And whereas, objections and suggestions received from the public on the said draft rules have been considered by
the Central Government;
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central
Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to
amend the Drugs Rules, 1945, namely: —
1. (1) These rules may be called the Drugs (Twelfth Amendment) Rules, 2026.
(2) They shall come into force from the date of their publication in the Official Gazette.
2. In the Drugs Rules, 1945, in rule 89, for the words and figures “Form 25 or Form 28” the words, figures and letters
“Form 25 or Form 25A or Form 25F or Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA or 28E or
Form 28F” shall be substituted.
[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. 28-10/45H (1), dated the
21st December, 1945 and last amended vide notification number G.S.R. 706 (E), dated the 30th July, 2026.
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