e-Gazette statutory gazette instrument G.S.R. 299(E) · 22 Apr 2026
Official title
Draft Proposal for amendment under Rule 89 of Drugs Rules 1945, for obtaining licence under Form 29 for different categories falling under Form 25A, 25F, 28A, 28B, 28D, 28DA, 28E, 28F
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Check the official recordThe Central Government proposes an amendment to Rule 89 of the Drugs Rules 1945. This change expands the list of manufacturing licence forms that allow an applicant to obtain a licence in Form 29 for examination, test, or analysis. The current rule only references Form 25 and Form 28. The amendment adds Form 25A, Form 25F, Form 28A, Form 28B, Form 28D, Form 28DA, and Form 28F to this list. The public may submit objections or suggestions to the Ministry of Health and Family Welfare within thirty days from the date the Gazette notification becomes available to the public. The final rules will take effect three months after their publication in the Official Gazette.
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2820 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, 21 अप्रैल, 2026 सा.का.जन. 299(अ).— औषजध जनयम, 1945 में और संिोधन करने के जलए कुछ जनयमों का जनम्नजलजखत प्रारूप, जिसे केंद्र 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 से परामिड के बाि बनाना प्रस्ट्ताजवत करती है, इसके द्वारा प्रभाजवत होने की संभावना वाले सभी व्यजियों की िानकारी के जलए एतद्द्वारा प्रकाजित दकया िाता है; और एतद्द्वारा नोरिस दिया िाता है दक उि प्रारूप जनयमों को उस तारीख से तीस दिन की अवजध समाप्त होने पर या उसके बाि जवचारार्ड स्ट्वीकार कर जलया िाएगा जिस तारीख को इन प्रारूप जनयमों वाले भारत के रािपत्र की प्रजतयां िनता के जलए उपलब्ध कराई िाती हैं। उि अवजध के भीतर दकसी भी व्यजि से प्राप्त होने वाली आपजत्तयों और सुझावों पर केंद्र सरकार द्वारा जवचार दकया िाएगा। आपजत्तयां और सुझाव, यदि कोई हों, अवर सजचव (औषजध जवजनयमन), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत सरकार, यू-6, वकड हॉल- सी ववंग, पहली मंजिल, कतडव्य भवन-1, नई दिल्ली, 110001 को संबोजधत दकए िा सकते हैं या drugsdiv-mohfw@gov.in पर ईमेल दकए िा सकते हैं।
सं. 275] नई दिल्ली, मंगलवार, अप्रैल 21, 2026/वैिाख 1, 1948
No. 275] NEW DELHI, TUESDAY, APRIL 21, 2026/VAISAKHA 1, 1948
सी.जी.-डी.एल.-अ.-22042026-271969 CG-DL-E-22042026-271969
2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] प्रारूप जनयम
MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 21st April, 2026. G.S.R. 299(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 Regulation), 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
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.… (E), 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. KUMER CHAND MEENA Digitally signed by KUMER CHAND MEENA Date: 2026.04.22 14:13:16 +05'30'
