e-Gazette statutory gazette instrument G.S.R. 505(E) · 25 Jun 2026
Official title
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
Official record
Open source pageSummary
The Ministry of Health and Family Welfare has published draft rules to amend Rule 31 of the Drugs Rules, 1945. The proposed amendment mandates that the licensing authority shall not permit the import of any drug with less than one year of residual shelf-life at the time of import. For biological drugs and radiopharmaceuticals, the requirement is adjusted to allow 60% of the labelled shelf-life. The government invites objections and suggestions from the public within thirty days from the date the Gazette notification is made available to the public. Submissions may be sent by post to the Under Secretary (Drugs) in New Delhi or via email.
What you must do
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4612 GI/2026 (1)
रजिस्ट्री सं. डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण् ड (i) PART II—Section 3—Sub-section (i) प्राजधकार से प्रकाजित PUBLISHED BY AUTHORITY स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसूचना नई दिल्ली, 22 िून, 2026 सा.का.जन. 505(अ).— औषजध जनयमावली, 1945 में और संिोधन करने के जलए कजतपय जनयमों का जनम्नजलजखत प्रारूप, जिसे 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) से परामिड के पश्चात, उन सभी व्यजियों की िानकारी के जलए प्रकाजित करती है जिनके इससे प्रभाजवत होने की संभावना है; और इसके द्वारा यह सूचना िी िाती है दक उि प्रारूप जनयमों पर उस तारीख से, जिसको इस प्रारूप जनयम वाले भारत के रािपत्र की प्रजतयां िनता को उपलब्ध करा िी िाती हैं, 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। सं. 454] नई दिल्ली, सोमवार, िून 22, 2026/आषाढ 1, 1948
No. 454] NEW DELHI, MONDAY, JUNE 22, 2026/ASHADHA 1, 1948
सी.जी.-डी.एल.-अ.-25062026-273833 CG-DL-E-25062026-273833
2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] आपजत्तयां और सुझाव, यदि कोई हों, अवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत सरकार, यू-6, वकड हॉल- सी ववंग, प्रथम तल, कतडव्य भवन-1, नई दिल्ली, 110001 को संबोजधत दकए िा सकते हैं या drugsdiv-mohfw@gov.in पर ईमेल दकए िा सकते हैं। प्रारूप जनयम
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. SARVESH KUMAR SRIVASTAVA Digitally signed by SARVESH KUMAR SRIVASTAVA Date: 2026.06.25 22:19:46 +05'30'
