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Date: 2026-06-30 Category: Extra Ordinary State: Union Government Country: India

Notification regarding inclusion of additional items under the Centrally Licensed Approval Authority (CLAA) provisions in the Drugs Rules, 1945

Issued by Ministry of Health and Family Welfare · Not Applicable

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Executive Summary & Key Takeaways

**Executive Summary** The Ministry of Health and Family Welfare has notified the Drugs (Eighth Amendment) Rules, 2026, which further amend the Drugs Rules, 1945. These rules aim to include specialized biotechnology products, such as cell-derived and gene therapeutic products, within existing regulatory frameworks for recombinant DNA drugs. The amendment was finalized after a 30-day public consultation period and took effect on June 30, 2026. **Key Points / Main Content** **Product Scope Expansion** * The amendments introduce a specific category of products: "Cell or Stem Cell derived products, Gene therapeutic products or Xenografts." * These products are now regulated alongside "Recombinant DNA (r-DNA) derived drugs." **Amendments to Regulatory Rules** * **Rule 75 & 75A:** The new product categories are inserted into sub-rule (3) and sub-rule (1A) respectively to ensure they are covered under established drug protocols. * **Rule 76 & 76A:** References to r-DNA derived drugs are substituted or expanded to include cell-derived products, gene therapeutics, and xenografts wherever they occur in these rules. **Updates to Official Forms (Schedule A)** * **Form 27D & 27DA:** The headings and relevant sections of these forms are updated to include the new product categories, ensuring licensing applications for these therapies are standardized. * **Form 28D & 28DA:** These forms are amended to substitute or insert the new categories into their headings and content, aligning them with the expanded scope of the Drugs Rules. **Administrative Compliance** * The rules were developed following consultation with the Drugs Technical Advisory Board (DTAB). * The notification confirms that no objections or suggestions were received regarding the draft rules published in October 2025. **Impact Analysis** **Manufacturers and Importers of Biotechnology Products** **Impact** Manufacturers and importers of cell-derived, stem-cell, gene therapy, and xenograft products are now subject to the specific provisions of the Drugs Rules, 1945, previously focused on r-DNA drugs. **Action Required** They must use the updated Forms (27D, 27DA, 28D, 28DA) for licensing and ensure all technical documentation complies with the amended Rules 75, 75A, 76, and 76A. **Regulatory and Licensing Authorities** **Impact** Authorities now have a clear legal mandate to regulate gene therapy and cell-derived products under the updated headings of the Drugs Rules. **Action Required** Licensing bodies must update their administrative processes and application review systems to incorporate the revised terminology and expanded product categories. **Drugs Technical Advisory Board (DTAB)** **Impact** The board is responsible for the technical oversight leading to these amendments. **Action Required** Continued monitoring of the implementation of these rules to ensure technical standards for the newly included product categories are maintained.

Key Entities Referenced

Drugs (Eighth Amendment) Rules, 2026: The specific regulatory policy introduced to amend existing rules to include cell or stem cell derived products, gene therapeutic products, and xenografts within its scope. Drugs Rules, 1945: The principal set of rules governing the manufacture, sale, and distribution of drugs in India, which this notification modifies. Drugs and Cosmetics Act, 1940: The primary legislation that provides the legal framework and authority for the Central Government to regulate drugs and cosmetics. Drugs Technical Advisory Board: The statutory advisory body consulted by the Central Government to provide technical expertise on the amendments to the drug rules. Ministry of Health and Family Welfare: The primary regulator and government department responsible for issuing the notification and overseeing the implementation of drug regulations.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-02072026-274000 CG-DxLx-xEG-I0D2H0x7x2x0 26-274000 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.ं 477] नई दिल्ली, मगं लवार, िनू 30, 2026/ आषाढ 9, 1948 26/पौष 17, 1947 No. 477] NEW DELHI, TUESDAY, JUNE 30, 2026/ ASHADHA 9, 1948 /PAUSHA 17, 1947 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 29 िून, 2026 सा.का.जन. 530(अ).—औषजध जनयम, 1945 म ें और 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 अपेजित रूप स,े भारत सरकार, स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) की अजधसूचना संख्या सा.का.जन. 758 (अ), तारीख 16 अक्टूबर, 2025 द्वारा, भारत के रािपत्र, असाधारण, भाग 2, खंड 3, उप-खडं (i) म ें प्रकाजित दकया गया था, जिसम ें ऐस े व्यजियों स,े िो उससे प्रभाजवत होने की संभावना रखते ह,ैं उस अवजध की समाजि स े पूवव, िो उि अजधसूचना वाल े रािपत्र की प्रजतया ं िनता को उपलब्ध कराय े िान े की तारीख स े तीस दिन की थी, आिेप और सुझाव आमंजत्रत दकए गए थ;े और, उि रािपत्र की प्रजतयां िनता को 18 अक्टूबर, 2025 को उपलब्ध कराई गई थीं; और, उि प्रारूप जनयमों के संबंध म ें िनता स ेकोई आिेप और सुझाव प्राि नहीं हुए; अतः अब केंद्रीय सरकार उि अजधजनयम की धारा 12 और धारा 33 द्वारा प्रित्त िजियों का प्रयोग करत े हुए और औषजध तकनीकी सलाहकार बोडव स े परामि व के पश्चात ् एतद्द्वारा औषजध जनयम, 1945 म ें और संिोधन करन े के जलए जनम्नजलजखत जनयम बनाती ह,ै अथावत:् — 1. (1) इन जनयमों का संजिि नाम औषजध (आठवााँ संिोधन) जनयम, 2026 ह।ै (2) य ेजनयम रािपत्र म ेंउनके प्रकािन की तारीख को प्रवृत्त होंगे। 4848 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] 2. औषजध जनयम, 1945 म,ें ─ (i). जनयम 75 म,ें उप-जनयम (3) म,ें " रर-कॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां," िब्िों, अिरों और कोष्ठकों के पश्चात,् "सले या स्ट्टेम सेल व्युत्पन्न उत्पाि, िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट," िब्ि अंतःस्ट्थाजपत दकए िाएंगे; (ii). जनयम 75ए म,ें उप-जनयम (1ए) म,ें "रर-कॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधया"ं िब्िों, अिरों और कोष्ठकों के पश्चात,् "' सले या स्ट्टेम सले व्युत्पन्न उत्पाि', 'िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट'" िब्ि अंतःस्ट्थाजपत दकए िाएगं े; (iii). जनयम 76 म,ें "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां" िब्िों, अिरों और कोष्ठकों के स्ट्थान पर, िहां कहीं भी वे आते हों, "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां, सेल या स्ट्टेम सेल व्युत्पन्न उत्पाि, िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट," िब्ि प्रजतस्ट्थाजपत दकए िाएंग;े (iv). जनयम 76 ए म,ें "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां" िब्िों, अिरों और कोष्ठकों के स्ट्थान पर, "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां, सेल या स्ट्टेम सले व्युत्पन्न उत्पाि, िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट," िब्ि प्रजतस्ट्थाजपत दकए िाएंग;े (v). अनुसूची ए म,ें─ (क) प्ररूप 27डी म,ें ─ (क) िीषवक म,ें "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां" िब्िों, अिरों और कोष्ठकों के स्ट्थान पर, "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां/ सेल या स्ट्टेम सेल व्युत्पन्न उत्पाि, िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट," िब्ि प्रजतस्ट्थाजपत दकए िाएगं े; (ख) "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां," िब्िों, अिरों और कोष्ठकों के बाि, "सले या स्ट्टेम सेल व्युत्पन्न उत्पाि, िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट," िब्ि अंतःस्ट्थाजपत दकए िाएंगे; (ख) प्ररूप 27 डीए म,ें ─ (क) िीषवक म,ें "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां" िब्िों, अिरों और कोष्ठकों के स्ट्थान पर, "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां/सेल या स्ट्टेम सले व्युत्पन्न उत्पाि, िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट," िब्ि प्रजतस्ट्थाजपत दकए िाएगं े; (ख) "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां," िब्िों, अिरों और कोष्ठकों के बाि, "सले या स्ट्टेम सेल व्युत्पन्न उत्पाि, िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट," िब्ि अंतःस्ट्थाजपत दकए िाएंगे; (ग) प्ररूप 28डी म,ें ─ (क) िीषवक म,ें "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां" िब्िों, अिरों और कोष्ठकों के स्ट्थान पर, "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां/सेल या स्ट्टेम सले व्युत्पन्न उत्पाि, िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट," िब्ि प्रजतस्ट्थाजपत दकए िाएगं े; (ख) "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां," िब्िों, अिरों और कोष्ठकों के बाि, "सले या स्ट्टेम सेल व्युत्पन्न उत्पाि, िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट," िब्ि अंतःस्ट्थाजपत दकए िाएंगे; (घ) प्ररूप 28डीए म,ें ─ (क) िीषवक म,ें "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां" िब्िों, अिरों और कोष्ठकों के स्ट्थान पर, "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां/सेल या स्ट्टेम सले व्युत्पन्न उत्पाि, िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट," िब्ि प्रजतस्ट्थाजपत दकए िाएगं े; (ख) "ररकॉजबबनेंट डीएनए (आर-डीएनए) स े व्युत्पन्न औषजधयां," िब्िों, अिरों और कोष्ठकों के बाि, "सले या स्ट्टेम सेल व्युत्पन्न उत्पाि, िीन जचदकत्सीय उत्पाि या जेनोग्राफ्ट," िब्ि अंतःस्ट्थाजपत दकए िाएंगे; [फा.स.ं एक्स.11014/07/2025-डीआर-भाग(2)] हष व मंगला, संयुि सजचव रटप्पण: औषजध जनयम, 1945 को अजधसूचना स.ं एफ. 28-10/45एच(1), तारीख 21 दिसंबर, 1945 द्वारा रािपत्र म ें प्रकाजित दकया गया था और अंजतम संिोधन अजधसूचना संख्या सा.का.जन. 506(अ), तारीख 22 िून, 2026 द्वारा दकया गया था।[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 29th June 2026 G.S.R. 530(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. 758 (E), dated the 16th October, 2025, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), 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 Gazette containing the said notification were made available to the public; And whereas, copies of the said Gazette were made available to the public on the 18th October, 2025; And whereas, no objections and suggestions received from the public on the said draft rules; Now, therefore, in exercise of the powers conferred by section 12 and section 33 of the said Act, the Central Government, after consultation with the 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 (Eighth Amendment) Rules, 2026. (2) These rules shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs Rules, 1945, ─ (i). in rule 75, in sub-rule (3), after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,” shall be inserted; (ii). in rule 75A, in sub-rule (1A), after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs”, the words "‘Cell or Stem Cell derived products’, ‘Gene therapeutic products or Xenografts’" shall be inserted; (iii). in rule 76, for the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs” wherever may occur, the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs, Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,” shall be substituted; (iv). in rule 76A, for the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs”, the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs, Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,” shall be substituted; (v). in SCHEDULE A, ─ (a) in Form 27D, ─ (A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”, the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS,” shall be substituted; (B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,” shall be inserted; (b) in Form 27DA, ─ (A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”, the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS,” shall be substituted; (B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,” shall be inserted; (c) in Form 28D, ─4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] (A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”, the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS,” shall be substituted; (B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,” shall be inserted; (d) in Form 28DA, ─ (A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”, the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS,” shall be substituted; (B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,” shall be inserted; [F. No. X.11014/07/2025-DR-Part(2)] 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. 506(E), dated 22nd June, 2026 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.

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