**Executive Summary**
The Ministry of Health and Family Welfare has notified the Drugs (Fifth Amendment) Rules, 2026, which further amend the Drugs Rules, 1945. These rules, finalized after a public consultation period initiated in December 2025, primarily concern the omission of specific entries in Schedule K. The amendment came into force on June 15, 2026, upon its publication in the Official Gazette.
**Key Points / Main Content**
* **Legal Authority and Process**
* The rules are issued under the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
* The amendment was made following consultation with the Drugs Technical Advisory Board.
* The final notification follows a draft period where objections and suggestions from the public were invited and considered by the Central Government.
* **Specific Amendments to the Drugs Rules, 1945**
* The amendment is officially titled the "Drugs (Fifth Amendment) Rules, 2026."
* A specific change has been made to Schedule K of the principal rules.
* Under the "Class of Drugs" column for serial number 13, item number (7), the word "Syrups" has been omitted.
* **Effective Date**
* The changes are immediate and became effective on the date of their publication in the Official Gazette (June 15, 2026).
**Impact Analysis**
**Pharmaceutical Manufacturers and Distributors**
**Impact**
"Syrups" are no longer categorized under item number (7) of serial number 13 in Schedule K. This change potentially alters the regulatory exemptions or requirements previously applicable to syrups under this specific entry.
**Action Required**
Review product portfolios and manufacturing standards to ensure that the production and distribution of syrups comply with the amended Schedule K regulations.
**Regulatory and Licensing Authorities**
**Impact**
The legal criteria for oversight regarding drugs listed in Schedule K have been updated.
**Action Required**
Update inspection checklists and regulatory enforcement protocols to reflect the omission of "Syrups" from the specified item in Schedule K.
**Healthcare Providers and Pharmacists**
**Impact**
The classification of certain liquid oral medications under the Drugs Rules has changed.
**Action Required**
Stay informed of the regulatory status of syrups to ensure compliant procurement and dispensing practices.
Key Entities Referenced
Drugs (Fifth Amendment) Rules, 2026: The specific regulatory amendment that omits the word 'Syrups' from item number (7) under serial number 13 in Schedule K.
Drugs Rules, 1945: The principal set of rules governing the manufacture, sale, and distribution of drugs in India, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: The enabling legislation that empowers the Central Government to frame and amend rules for regulating drugs and cosmetics.
Drugs Technical Advisory Board: The statutory body consulted by the Central Government to provide technical advice before finalizing the amendments to the Drugs Rules.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-15062026-273467
CG-DxLx-xEG-I1D5H0x6x2x0 26-273467
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 427] नई दिल्ली, सोमवार, िनू 15, 2026/ज्य ष्े ठ 25, 1948
No. 427] NEW DELHI, MONDAY, JUNE 15, 2026/JYAISTHA 25, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 9 िून, 2026
सा.का.जन. 477(अ).— औषजध जनयम, 1945 का और संिोधन करने के जलए कजतपय जनयमों का प्रारूप, औषजध
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. 927 (अ), तारीख 29 दिसंबर, 2025 द्वारा भारत के रािपत्र, असाधारण, भाग II, खंड 3,
उप-खंड (i), तारीख 30 दिसंबर, 2025 म ें प्रकाजित दकया गया था, जिसम ें उक्त अजधसूचना वाली सरकारी रािपत्र की
प्रजतयां िनता को उपलब्ध कराए िाने की तारीख स े तीस दिन की अवजध की समाजि स े पहले, जिससे प्रभाजवत होन े की
संभावना वाले व्यजक्तयों स ेआिपे और सुझाव आमंजत्रत दकए गए थ;े
और, उक्त सरकारी रािपत्र की प्रजतयां िनता को 30 दिसंबर, 2025 को उपलब्ध करा िी गई थीं;
और, उक्त प्रारूप जनयमों पर िनता स े प्राि आिेपों और सुझावों पर केंद्रीय सरकार द्वारा जवचार दकया गया ह;ै
4302 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
अतः, केंद्रीय सरकार अब, उक्त अजधजनयम की धारा 12 और धारा 33 द्वारा प्रित्त िजक्तयों का प्रयोग करत ेहुए, औषजध
तकनीकी सलाहकार बोड ड स े परामि ड करने के पश्चात,् औषजध जनयम, 1945 का और संिोधन करन े के जलए जनम्नजलजखत
जनयम बनाती ह,ै अथाडत:् —
1. (1) इन जनयमों का संजिि नाम औषजध (पााँचवा संिोधन) जनयम, 2026 ह।ै
(2) ये रािपत्र म ेंइनके प्रकािन की तारीख को प्रवृत्त होंगे।
2. औषजध जनयम, 1945 की, अनसु ूची 'ट' के, स्ट्तंभ म,ें 'औषजधयों का वगड' िीषडक के अधीन, क्रम संख्या 13 के सामने, मि
संख्या (7) म,ें “जसरप,” िब्ि का लोप दकया िाएगा।
[फा. सं. एक्स.11014/11/2025-डीआर]
हष ड मंगला, संयुक् त सजचव
रटप्पण: औषजध जनयम, 1945 रािपत्र म ेंअजधसूचना स.ं एफ. 28-10/45एच(1), तारीख 21 दिसंबर, 1945 द्वारा प्रकाजित
दकए गए थ ेऔर अजधसूचना संख्या सा.का.जन. 444(अ), दिनाकं 1 िून, 2026 द्वारा अंजतम सिं ोधन दकया गया था।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 9th June, 2026
G.S.R. 477(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945 were 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. 927 (E), dated the 29th December, 2025 published in the
Gazette of India, Extraordinary, Part II, section 3, sub-section (i), dated the 30th December, 2025 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 Official Gazette containing the said notification were made available to the public;
And whereas, copies of the said Official Gazette were made available to the public on the 30th December, 2025;
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 (Fifth Amendment) Rules, 2026.
(2) 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 column, under the heading Class of Drugs, against serial
number 13, in item number (7), the word “Syrups,” shall be omitted.
[F. No. X.11014/11/2025-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 the December, 1945 and last amended vide notification number G.S.R. 444(E), dated.1st June, 2026.
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