e-Gazette statutory gazette instrument G.S.R. 509(E) · 26 Jun 2026
Official title
Proposal for simplification of the process for obtaining test licences for import of drugs under Form 11 of the Drugs Rules, 1945, through an acknowledgement based system
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The Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to introduce an acknowledgement-based system for importing drugs for analytical and non-clinical testing. Under the proposed rules, applicants may import such drugs by submitting an online application in Form 12 as prior intimation to the Central Licencing Authority, rather than obtaining a formal licence. This simplified process excludes specific categories such as sex hormones, cytotoxic drugs, beta-lactams, biologics containing live microorganisms, and narcotics or psychotropic substances. The proposal includes consequential amendments to rules 33, 34, and 35, and Form 12, to integrate the acknowledgement of prior intimation alongside existing licensing provisions. The government invites public objections and suggestions within thirty days of the gazette publication.
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4637 GI/2026 (1) रजजस्ट्री सं. डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx xxxGIDExxx ऄसाधारण EXTRAORDINARY भाग II—खण् ड 3—ईप-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) ऄजधसूचना नइ ददल्ली, 23 जून, 2026 सा.का.जन. 509(ऄ).— औषजध जनयम, 1945 में और संिोधन करने के जलए जनम्नजलजखत प्रारूप जनयम, जजन्हें केंद्र सरकार औषजध और प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 12 की ईप-धारा (1) द्वारा प्रदत्त िजियों का प्रयोग करते हुए, औषजध तकनीकी सलाहकार बोडड के परामिड से बनाना प्रस्ट्ताजवत करती है, एतद्द्वारा ईन सभी व्यजियों की जानकारी के जलए प्रकाजित दकए जाते हैं जजनके प्रभाजवत होने की संभावना है, और एतद्द्वारा यह नोरिस ददया जाता है दक ईि प्रारूप जनयमों पर ईस तारीख से तीस ददन की ऄवजध समाप्त होने पर या ईसके बाद जवचार दकया जाएगा जजस तारीख को आन प्रारूप जनयमों वाले भारत के राजपत्र की प्रजतयां जनता के जलए ईपलब्ध कराइ जाती हैं। ईि ऄवजध के भीतर दकसी भी व्यजि से प्राप्त होने वाली अपजत्तयों और सुझावों पर केंद्र सरकार द्वारा जवचार दकया जाएगा। अपजत्तयां और सुझाव, यदद कोइ हों, ऄवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत सरकार, यू-6, वकड हॉल-सी ववग, पहली मंजजल, कतडव्य भवन-1, नइ ददल्ली, 110001 को संबोजधत दकए जा सकते हैं या drugsdiv-mohfw@gov.in पर इमेल दकए जा सकते हैं। प्रारूप जनयम सं. 458] नइ ददल्ली, मंगलवार, जून 23, 2026/अषाढ 2, 1948
No. 458] NEW DELHI, TUESDAY, JUNE 23, 2026/ASHADHA 2, 1948
सी.जी.-डी.एल.-अ.-26062026-273857 CG-DL-E-26062026-273857
2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
3 ईि जनयमों में, जनयम 34 में, ― (a) ईपांत िीषडक में, "ऄनुज्ञजप्त" िब्द के स्ट्थान पर, "ऄनुज्ञजप्त या पूवड सूचना" िब्द प्रजतस्ट्थाजपत दकए जाएंगे; (b) ईप-जनयम (1) के पश्चात्, जनम्नजलजखत परंतुक ऄंतःस्ट्थाजपत दकया जाएगा, ― परंतु यह दक जवश्लेषणात्मक और गैर-नैदाजनक परीक्षण के जलए औषजध के अयात के मामले में (यौन हामोन, साआिोिॉजससक, बीिा लैसिम, जीजवत सूक्ष्मजीवों वाले बायोलॉजजसस और नारकोरिसस और साआकोरोजपक दवाओं की श्रेणी की दवाओं को छोड़कर) केंद्रीय ऄनुज्ञजप्त प्राजधकारी को प्ररूप 12 में एक ऑनलाआन अवेदन पूवड सूचना के रूप में प्रस्ट्तुत दकया जाएगा और अवेदक ऐसी सूचना की पावती के अधार पर ऐसी औषजध का अयात कर सकता है।"; 4 ईि जनयमों में, जनयम 35 में, ― (a) ईपांत िीषडक में, "ऄनुज्ञजप्त" िब्द के स्ट्थान पर, "ऄनुज्ञजप्त या पूवड सूचना की पावती" िब्द प्रजतस्ट्थाजपत दकए जाएंगे; (b) ईप-जनयम (1) में, "ऄनुज्ञजप्त" िब्द जहां कहीं भी अता है, ईसके स्ट्थान पर, "ऄनुज्ञजप्त या जनयम 34 के ईप-जनयम (1) के परंतुक के ऄधीन पूवड सूचना की पावती, जैसा भी मामला हो" िब्द, संख्या और कोष्ठक प्रजतस्ट्थाजपत दकए जाएंगे; (c) ईप-जनयम (2) के स्ट्थान पर जनम्नजलजखत प्रजतस्ट्थाजपत दकया जाएगा ―
[भाग II—खण् ड 3(i)] भारत का राजपत्र : ऄसाधारण 3
कोइ ऄनुज्ञजप्तधारी या जनयम 34 के ईप-जनयम (1) के परंतुक के ऄधीन पूवड सूचना की पावती का धारक —जजसकी ऄनुज्ञजप्त या पूवड सूचना की पावती रद्द कर दी गइ हो—अदेि की तारीख से तीन महीने के भीतर केंद्र सरकार के पास ऄपील कर सकता है। 5 ईि जनयम में, ऄनुसूची क में, ― प्ररूप 12 में, ― (a) िीषडक में, "ऄनुज्ञजप्त" िब्द के स्ट्थान पर, "ऄनुज्ञजप्त या पूवड सूचना" िब्द प्रजतस्ट्थाजपत दकए जाएंगे; (b) प्रारंजभक पैराग्राफ में, "ऄनुज्ञजप्त" िब्द के स्ट्थान पर, "ऄनुज्ञजप्त या पूवड सूचना" िब्द प्रजतस्ट्थाजपत दकए जाएंगे;
[फा. सं. डीसी-डीिी-11011(11)/5/2026-इऑदफस] हषड मंगला, संयुि सजचव रिप्पणी: औषजध जनयम, 1945 राजपत्र में ऄजधसूचना संख्या एफ. 28-10/45-एच(1). ददनांक 21 ददसंबर, 1945 के तहत प्रकाजित दकए गए थे और ऄंजतम बार ऄजधसूचना संख्या सा.का.जन.….ददनांक …. के तहत संिोजधत दकए गए थे।
MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 23rd June, 2026 G.S.R. 509(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 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. 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 (hereinafter referred to as the said rules), in rule 33, ― (i). in clause (a), for the word and number “Form 11”, the words, number and brackets “Form 11 or the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be” shall be substituted; (ii). In clause (b), ─ (a) for the word “licensee” the words, number and brackets “licensee or the holder of the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be” shall be substituted;
4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(b) for the word “licence” wherever it may occur, the words, numbers and brackets “licence or the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be” shall be substituted; (iii). In clause (c), for the word “licensee” the words, number and brackets “licensee or the holder of the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be” shall be substituted; (iv). In clause (d), ─ (a) for the word “licensee” the words, number and brackets “licensee or the holder of the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be” shall be substituted; (b) for the word “licence” the words, numbers and brackets “licence or the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be” shall be substituted; (v). In clause (e), ─ (a) for the word “licensee” the words, number and brackets “licensee or the holder of the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be” shall be substituted; (b) for the words “holders of licenses” the words, numbers and brackets “holders of licences or the acknowledgements of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be” shall be substituted; 3. In the said rules, in rule 34, ― (i). in the marginal heading, for the word “licence”, the words “licence or prior intimation” shall be substituted; (ii). After sub-rule (1), the following proviso shall be inserted, ― Provided that in case of import of drug for analytical and non-clinical testing (excluding drugs of category of sex hormones, cytotoxic, beta lactam, biologics with live microorganisms and narcotics and psychotropic drugs) an online application in Form 12 to the Central Licencing Authority shall be submitted as prior intimation and the applicant may import such drug based on the acknowledgment of such intimation."; 4. In the said rules, in rule 35, ― (i). in the marginal heading, for the word “licence”, the words “licence or acknowledgment of prior intimation” shall be substituted; (ii). in sub-rule (1), for the word “licence”, wherever it may occur, the words, numbers and brackets “licence or the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be” shall be substituted; (iii). for sub-rule (2), following shall be substituted ― A licensee or the holder of the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be, whose licence or acknowledgement of prior intimation has been cancelled, may appeal to Central Government within three months of the date of the order. 5. In the said rule, in Schedule A, ― (i). In Form 12, ― (a) In the heading, for the word “LICENCE”, the words “LICENCE OR PRIOR INTIMATION” shall be substituted; (b) In the opening paragraph, for the word “licence”, the words “licence or prior intimation” shall be substituted; [F. No. DC-DT-11011(11)/5/2026-eoffice] 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 the 21st December, 1945 and last amended vide notification number G.S.R….dated ….
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: 2026.06.26 13:02:29 +05'30'
