**Executive Summary**
The Ministry of Health and Family Welfare has notified the Drugs (Tenth Amendment) Rules, 2026, which further amends the Drugs Rules, 1945. The notification, published on July 9, 2026, introduces stricter regulations for oral formulations containing high alcohol content in specific volumes. These rules are set to come into force six months from the date of their publication in the Official Gazette.
**Key Points / Main Content**
**Amendments to Schedule K**
* Modifies the "Extent and Conditions of Exemptions" under serial number 10.
* Explicitly excludes oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) when packed and sold in quantities exceeding 30 milliliters from previous exemptions.
**Amendments to Schedule H1**
* A new entry (serial number 52) is added to Schedule H1.
* This entry includes all oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in containers or bottles larger than 30 milliliters.
* This classification subjects these high-alcohol formulations to the specific prescription and record-keeping requirements governing Schedule H1 drugs.
**Effective Date and Authority**
* The rules were made following consultation with the Drugs Technical Advisory Board.
* The amendment becomes effective six months post-publication (approximately January 2027).
**Impact Analysis**
**Pharmaceutical Manufacturers**
**Impact**
Manufacturers of oral formulations with more than 12% alcohol content in bottles larger than 30ml will see their products reclassified. These products lose certain exemptions and must now comply with Schedule H1 standards.
**Action Required**
Manufacturers must update product labeling, packaging, and compliance documentation to reflect the Schedule H1 status. Production and distribution processes must be adjusted before the six-month deadline.
**Retailers and Pharmacists**
**Impact**
Retailers will be required to handle these specific high-alcohol formulations under the strict protocols of Schedule H1, which includes mandatory prescription requirements and detailed sales record maintenance.
**Action Required**
Pharmacies must update their inventory management systems to flag these items as Schedule H1 and ensure that staff are trained on the new dispensing and record-keeping requirements for these products.
**Regulators and Licensing Authorities**
**Impact**
State and Central drug controllers will need to monitor the sale and distribution of these formulations more stringently to prevent misuse.
**Action Required**
Authorities must ensure that inspections and audits of pharmacies and manufacturing units include checks for compliance with the new Schedule H1 entry for high-alcohol oral formulations.
Key Entities Referenced
Drugs (Tenth Amendment) Rules, 2026: The specific regulation introduced to amend the conditions for oral formulations containing high alcohol content.
Drugs and Cosmetics Act, 1940: The primary legislation under which sections 12 and 33 grant the central government power to make and amend rules.
Drugs Rules, 1945: The principal set of rules being amended, specifically concerning exemptions in Schedule K and entries in Schedule H1.
Drugs Technical Advisory Board: The statutory advisory body consulted by the Central Government before finalizing these rule amendments.
Ministry of Health and Family Welfare: The primary government ministry responsible for the oversight and issuance of these regulatory amendments.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-09072026-274311
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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.ं 549] नई दिल्ली, बृहस्ट्प जतवार, िुलाई 9, 2026/आषाढ 18, 1948
No. 549] NEW DELHI, THURSDAY, JULY 9, 2026/ASHADHA 18, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 8 िुलाई, 2026
सा.का.जन. 607(अ).— औषजध जनयम, 1945 म ें और संिोधन करन े के जलए कजतपय जनयमों के 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 अपेजित रूप स,े भारत सरकार, स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) की
अजधसूचना संख्या सा.का.जन. 760 (अ), तारीख 16 अक्टूबर, 2025 द्वारा, भारत के रािपत्र, असाधारण, भाग II, खडं 3,
उप-खंड (i) म ें प्रकाजित दकया गया था, जिसम ें ऐसे व्यजियों स,े िो उससे प्रभाजवत होने की संभावना रखते ह ैं उस अवजध
की समाजि स े पूवव, िो उि अजधसूचना वाले रािपत्र की प्रजतयां िनता को उपलब्ध कराए िाने की तारीख स े तीस दिन की
थी, आिेप और सुझाव आमंजत्रत दकए गए थ:े
और, उि रािपत्र की प्रजतयां िनता को 18 अक्टूबर, 2025 को उपलब्ध करा िी गई थीं;
और, उि प्रारूप जनयमों के संबंध म ें िनता स ेकोई आिेप और सुझाव प्राि नहीं हुए;
5167 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
अतः, अब, केंद्रीय सरकार उि अजधजनयम की धारा 12 और 33 द्वारा प्रित्त िजियों का प्रयोग करत े हुए, और
औषजध तकनीकी सलाहकार बोडव के परामि व के पश्चात,् औषजध जनयम, 1945 म ें और संिोधन करने के जलए जनम्नजलजखत
जनयम बनाती ह,ै अथावत:् —
1. (i) इन जनयमों का संजिि नाम औषजध (िसवां संिोधन) जनयम, 2026 ह।ै
(ii) य े रािपत्र म ें इन जनयमों के प्रकािन के 6 मास पश्चात ्प्रवृत्त होंगे।
2. औषजध जनयम, 1945 म,ें ─
(i). अनुसूची के, म,ें छूट की सीमा और ितें िीषवक के अधीन, क्रम संख्या 10 के सामन,े "अजधजनयम और उसके अधीन
जनयम" िब्िों के पश्चात,् "30 जमलीलीटर स े अजधक की पैककंग या बोतलों म ें पैक और बेचे िाने वाले 12% स े
अजधक अल्कोहल आयतन/आयतन (एजथल अल्कोहल) वाले सभी मुखलेव्य जवजनर्मवजत को छोड़कर।" िब्ि, अंक,
प्रतीक, अिर और कोष्ठक अतं ःस्ट्थाजपत दकए िाएगं े;
(ii). अनुसूची एच1 म,ें "51. प्रगे ाबाजलन" प्रजवजि के पश्चात,् जनम्नजलजखत प्रजवजि अंतःस्ट्थाजपत की िाएगी, अथावत:् ─
“52. 30 जमलीलीटर स े अजधक की पैककंग या बोतलों म ें पकै और बेच े िाने वाले 12% स े अजधक अल्कोहल
आयतन/आयतन (एजथल अल्कोहल) वाले सभी मुखलेव्य जवजनर्मवजत”।
[फा. स.ं एक्स.11014/07/2025-डीआर-भाग(3)]
हष व मंगला, संयुक् त सजचव
रटप्पण: औषजध जनयम, 1945 को अजधसूचना संख्या एफ. 28-10/45एच(1), तारीख 21 दिसंबर, 1945 द्वारा रािपत्र म ें
प्रकाजित दकया गया था और उसम ेंअंजतम संिोधन अजधसूचना संख्या सा.का.जन. 561(अ), तारीख 2 िलु ाई, 2026
द्वारा दकया गया था।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 8th July, 2026
G.S.R. 607(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. 760 (E), dated the 16th October, 2025, 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 18th October, 2025;
And whereas, no objections and suggestions received from the public on the said draft rules;[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
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. (i) These rules may be called the Drugs (Tenth Amendment) Rules, 2026.
(ii) They shall come into force after the 6 months of publication of these rules in the Official Gazette.
2. In the Drugs Rules, 1945, ─
(i) in Schedule K, under the heading Extent and Conditions of Exemptions, against the serial no. 10, after the
words “Act and rules thereunder”, the words, figures, symbols, letters and brackets “except for all oral
formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles
of more than 30 milliliters.”, shall be inserted;
(ii) in Schedule H1, after the entry “51. Pregabalin”, the following entry shall be inserted, namely: ─
“52. All oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in
packings or bottles of more than 30 milliliters.”.
[F. No. X.11014/07/2025-DR-Part(3)]
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. 561(E), dated the 2nd July, 2026
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