Date: 2026-06-22Category: Extra OrdinaryState: Union GovernmentCountry: India
Request for approval to publish the Import Checklist related to shelf life below 60 percent and Overprinting Snickering Stamping as per Rule 104 A of the Drugs and Cosmetics Rules 1945
**Executive Summary**
The Ministry of Health and Family Welfare issued a notification on June 22, 2026, proposing the Drugs (Amendment) Rules, 2026, to modify the Drugs Rules, 1945. The amendment specifically targets Rule 31 to establish stricter residual shelf-life requirements for imported drugs. Stakeholders are invited to submit objections or suggestions within 30 days from the date the gazette copies are made available to the public.
**Key Points / Main Content**
**Proposed Regulatory Changes**
* **Amendment to Rule 31:** The draft rules propose substituting the second proviso of Rule 31 regarding the conditions for drug importation.
* **Residual Shelf-life for Standard Drugs:** The licensing authority will prohibit the import of any drug that has less than one year of residual shelf-life remaining on the date of import.
* **Exceptions for Specific Categories:** For Biological drugs and Radiopharmaceuticals, the minimum allowed residual shelf-life is set at 60% of the total labelled shelf-life.
**Administrative Details**
* **Title and Commencement:** The rules shall be cited as the Drugs (...... Amendment) Rules, 2026, and will come into force on a date specified by the Government upon final publication.
* **Consultation Process:** The Central Government will consider all feedback received within the 30-day notice period before finalizing the rules.
* **Submission Channels:** Objections and suggestions can be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or via email to drugsdiv-mohfw@gov.in.
**Impact Analysis**
**Licensing Authorities**
**Impact**
They will be responsible for enforcing the new residual shelf-life limits at ports of entry and ensuring no non-compliant drugs enter the country.
**Action Required**
Prepare to update import verification protocols to align with the one-year or 60% shelf-life requirements once the rules are finalized.
**Drug Importers and Manufacturers**
**Impact**
The rule limits their ability to import older stock or drugs nearing expiration, potentially affecting supply chain timelines and inventory management for biologicals and radiopharmaceuticals.
**Action Required**
Review current import schedules to ensure compliance with the new shelf-life thresholds and submit any objections or suggestions to the Ministry within the 30-day window.
**Ministry of Health and Family Welfare**
**Impact**
The Ministry is tasked with the administrative oversight of the amendment process and the drug technical advisory consultation.
**Action Required**
Collect, review, and consider all public feedback and suggestions before proceeding with the final publication of the rules in the Official Gazette.
Key Entities Referenced
Drugs Rules, 1945: The principal rules being amended to revise provisions under Rule 31 regarding the minimum residual shelf-life required for the import of drugs.
Drugs and Cosmetics Act, 1940: The parent legislation providing the Central Government with the statutory authority under Sections 12 and 33 to frame and amend drug-related rules.
Drugs (...... Amendment) Rules, 2026: The specific draft rules proposed to update import regulations, particularly establishing a one-year residual shelf-life requirement for imported drugs.
Drugs Technical Advisory Board (DTAB): The statutory board consulted by the Central Government to provide technical expertise on the proposed amendments to drug regulations.
Ministry of Health and Family Welfare: The primary central ministry responsible for issuing the notification and overseeing the regulatory framework for drugs and health in India.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-25062026-273833
CG-DxLx-xEG-I2D5H0x6x2x0 26-273833
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.ं 454] नई दिल्ली, सोमवार, िनू 22, 2026/आषाढ 1, 1948
No. 454] NEW DELHI, MONDAY, JUNE 22, 2026/ASHADHA 1, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 22 िून, 2026
सा.का.जन. 505(अ).— औषजध जनयमावली, 1945 म ेंऔर सिं ोधन करन ेके जलए कजतपय जनयमों का जनम्नजलजखत
प्रारूप, जिस े केंद्रीय 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 करते हुए, औषजध तकनीकी सलाहकार बोडड (Drugs
Technical Advisory Board) स े परामि ड के पश्चात, उन सभी व्यजियों की िानकारी के जलए प्रकाजित करती ह ै जिनके
इससे प्रभाजवत होन े की संभावना ह;ै और इसके द्वारा यह सचू ना िी िाती ह ै दक उि प्रारूप जनयमों पर उस तारीख स,े
जिसको इस प्रारूप जनयम वाल े भारत के रािपत्र की प्रजतयां िनता को उपलब्ध करा िी िाती ह,ैं तीस दिनों की अवजध की
समाजि पर या उसके पश्चात जवचार दकया िाएगा।
उि जवजनर्िडष्ट अवजध के भीतर दकसी भी व्यजि से प्राि आपजत्तयों और सुझावों पर केंद्रीय सरकार द्वारा जवचार
दकया िाएगा।
4612 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
आपजत्तयां और सुझाव, यदि कोई हों, अवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय, भारत सरकार,
यू-6, वकड हॉल- सी ववंग, प्रथम तल, कतडव्य भवन-1, नई दिल्ली, 110001 को संबोजधत दकए िा सकत े ह ैं या
drugsdiv-mohfw@gov.in पर ईमले दकए िा सकते ह।ैं
प्रारूप जनयम
1. (i) इन जनयमों का नाम औषजध (...... संिोधन) जनयम, 2026 कहा िा सकेगा।
(ii) य े जनयम रािपत्र (Official Gazette) म ें इनके अंजतम प्रकािन के समय सरकार द्वारा जवजनर्िडष्ट की िान े
वाली जतजथ स ेप्रवृत्त होंगे।
2. औषजध जनयमावली, 1945 के जनयम 31 म,ें जद्वतीय परंतुक (proviso) के स्ट्थान पर जनम्नजलजखत प्रजतस्ट्थाजपत दकया
िाएगा:-
"परंत ु यह और दक अनुज्ञापन प्राजधकारी (licensing authority) दकसी भी ऐसी औषजध के आयात की अनुमजत
नहीं िेगा जिसकी अवजिष्ट िल्े फ-लाइफ अवजध (residual shelf-life period) आयात की जतजथ को एक वष ड स े कम हो।
हालांदक, िैजवक औषजधयों (Biological drugs) और रेजडयोफामाडस्ट्युरिकल्स (Radiopharmaceuticals) के मामल े म,ें
अंदकत िल्े फ-लाइफ के 60% की अनुमजत िी िा सकती ह।ै "
[फा. स.ं X.11014/08/2026-डीआर]
हष ड मंगला, संयुि सजचव
रिप्पणी: औषजध जनयमावली, 1945 को अजधसूचना संख्या एफ. 28-10/45एच(1), दिनांक 21 दिसंबर, 1945 द्वारा
आजधकाररक रािपत्र म ेंप्रकाजित दकया गया था और अंजतम सिं ोधन अजधसूचना संख्या सा.का.जन.…..(इ), दिनांक.……
द्वारा दकया गया था।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 22nd June, 2026
G.S.R. 505(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), 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.[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
DRAFT RULES
(i)These rules may be called the Drugs (...... Amendment) Rules, 2026.
(ii)These rules shall come into force from the date as specified by the Government at the time of final publication of
the rules in the Official Gazette.
In the Drugs Rules, 1945, in Rule 31, the second proviso shall be substituted as follows:-
“Provided further that the licensing authority shall not allow the import of any drug having less than one year residual
shelf-life period as on the date of import. However, in the case of Biological drugs and Radiopharmaceuticals, 60% of
the labelled shelf-life may be allowed.”
[F. No. X.11014/08/2026-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.…..(E), dated the.……
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.