Date: 2026-07-03Category: Extra OrdinaryState: Union GovernmentCountry: India
Notification for consideration of Navi Mumbai International Airport (NMIA) as authorized Airport for Drug Import, under the provision of Rule 43A of Drugs Rules, 1945
**Executive Summary**
This notification announces the Drugs (Ninth Amendment) Rules, 2026, which amends the Drugs Rules, 1945. Issued by the Ministry of Health and Family Welfare following a public consultation period initiated in January 2026, the amendment officially includes Navi Mumbai as a recognized location under Rule 43A. These rules come into force on the date of their publication in the Official Gazette (July 3, 2026).
**Key Points / Main Content**
**Administrative Details**
* **Title:** The rules are cited as the Drugs (Ninth Amendment) Rules, 2026.
* **Authority:** The amendment is made by the Central Government in exercise of powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board.
* **Effective Date:** The provisions become effective immediately upon their publication in the Official Gazette.
**Specific Rule Amendments**
* **Amendment of Rule 43A:** The notification modifies Rule 43A of the Drugs Rules, 1945.
* **Geographic Expansion:** The words "Cochin and Thiruvananthapuram" are replaced with "Cochin, Thiruvananthapuram and Navi Mumbai," effectively adding Navi Mumbai to the specified locations under this rule.
**Legislative History**
* **Draft Notification:** A draft was previously published on January 28, 2026, as G.S.R. 66(E) to invite public objections and suggestions.
* **Public Response:** No objections or suggestions were received from the public regarding the draft rules within the thirty-day window provided.
**Impact Analysis**
**Stakeholders: Pharmaceutical Importers, Manufacturers, and Logistics Providers**
**Impact**
Navi Mumbai is now officially recognized alongside Cochin and Thiruvananthapuram under Rule 43A of the Drugs Rules. This expands the designated locations available for activities governed by this specific rule.
**Action Required**
Entities operating in or through Navi Mumbai must ensure their processes and documentation align with the updated requirements of Rule 43A as of the effective date.
**Stakeholders: Regulatory and Customs Authorities**
**Impact**
Authorities must now recognize and include Navi Mumbai in their regulatory oversight and enforcement frameworks pertaining to Rule 43A.
**Action Required**
Regulatory bodies must update internal guidelines and port-of-entry protocols to reflect the inclusion of Navi Mumbai in the amended Drugs Rules.
Key Entities Referenced
Drugs (Ninth Amendment) Rules, 2026: The specific regulatory amendment introduced to modify Rule 43A of the existing drug framework.
Drugs Rules, 1945: The principal rules governing drug regulation in India which are being amended to include new designated locations.
Drugs and Cosmetics Act, 1940: The parent legislation that empowers the Central Government to make and amend rules for regulating drugs and cosmetics.
Navi Mumbai: The specific location added to Rule 43A as a designated point for drug-related regulatory entry or applicability.
Drugs Technical Advisory Board: The statutory advisory body consulted by the Central Government to provide expert input on the rule amendments.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-07072026-274223
CG-DxLx-xEG-I0D7H0x7x2x0 26-274223
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.ं 503] नई दिल्ली, िुक्रवार, िुलाई 3, 2026/आषाढ 12, 1948 26/पौष 17, 1947
No. 503] NEW DELHI, FRIDAY, JULY 3, 2026/ASHADHA 12, 1948 /PAUSHA 17, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 2 िुलाई, 2026
सा.का.जन. 561(अ).— औषजध जनयम, 1945 का संिोधन करने के जलए कजतपय जनयमों के प्रारूप को, 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, स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) की
अजधसूचना संख्या सा.का.जन. 66(अ), तारीख 28 िनवरी, 2026 द्वारा भारत के रािपत्र, असाधारण, भाग 2, खडं 3, उप-
खंड (i) म ें तारीख 28 िनवरी, 2026 को प्रकाजित दकया गया था, जिसम ें ऐस े व्यजियों स,े िो उससे प्रभाजवत होन की
संभावना रखते ह,ैं उस अवजध की समाजि स ेपूवव िो उि अजधसूचना वाले रािपत्र की प्रजतयां िनता को उपलब्ध कराय ेिान े
की तारीख स े तीस दिन थी, आिेप और सुझाव आमंजत्रत दकए गए थे’
और, उि िासकीय सरकारी रािपत्र की प्रजतयां िनता को 28 िनवरी, 2026 को उपलब्ध करा िी गई थीं;
और, उि प्रारूप जनयमों के संबंध िनता स े कोई आपजियां और सुझाव प्राि नहीं हुए थ;े
5012 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
अतः, अब, केंद्रीय सरकार औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 और धारा
33 द्वारा प्रिि िजियों का प्रयोग करते हुए, केंद्रीय सरकार, औषजध तकनीकी सलाहकार बोडव स े परामि व के बाि, औषजध
जनयम, 1945 का और संिोधन करन े के जलए जनम्नजलजखत जनयम बनाती ह,ै अथावत:् -
1. (1) इन जनयमों का संजिपत नाम औषजध (नौवां संिोधन) जनयम, 2026 ह।ै
(2) य े िासकीय रािपत्र म ेंउनके प्रकािन की तारीख स ेप्रवृि होंगे।
2. औषजध जनयम, 1945 म,ें जनयम 43क म,ें "कोचीन और जतरुवनंतपुरम" िब्िों के स्ट्थान पर, "कोचीन, जतरुवनंतपरु म और
नवी मुंबई" िब्ि प्रजतस्ट्थाजपत दकए िाएंगे।
[फा. स.ं एक्स.11035/131/2022-डीआर]
हष व मंगला, संयुि सजचव
रिप्पण: औषजध जनयम, 1945 सरकारी रािपत्र म ें अजधसूचना संख्या एफ. 28-10/45-एच(1) तारीख 21 दिसंबर, 1945
द्वारा प्रकाजित दकए गए थ ेऔर उसम ेंअंजतम संिोधन अजधसूचना संख्या सा.का.जन. 530(अ), तारीख 29 िून, 2026 द्वारा
दकया गया था।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 2nd July, 2026
G.S.R. 561(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. 66(E), dated the 28th January, 2026 published in the Gazette of India, Extraordinary,
Part II, section 3, sub-section (i) dated the 28th January, 2026, 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 28th January, 2026;
And whereas, no objections and suggestions were received from the public in respect of the said draft rules;
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act,
1940 (23 of 1940), the Central Government, after consultation with 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 (Ninth 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 rule 43A, for the words “Cochin and Thiruvananthapuram”, the words, “Cochin,
Thiruvananthapuram and Navi Mumbai” shall be substituted.
[F. No. X.11035/131/2022-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. 530(E), dated 29th June, 2026
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and Published by the Controller of Publications, Delhi-110054.