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Date: 13-Mar-2023 Category: Extra Ordinary State: Union Government Country: India

Use of induced Pluripotent Stem Cells additional testing methods

Issued by Ministry of Health and Family Welfare · Department of Health and Family Welfare

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Executive Summary & Key Takeaways

What it means

  • The gazette notification introduces the New Drugs and Clinical Trials (Amendment) Rules, 2023. These rules amend the New Drugs and Clinical Trials Rules, 2019, specifically focusing on non-clinical study requirements for new drugs.
  • The amendment incorporates updated non-clinical testing methods for assessing the safety and efficacy of new drugs, including cell-based assays, organ chips, microphysiological systems, sophisticated computer modeling, human biology-based test methods, and animal studies.

Key Changes

  • The New Drugs and Clinical Trials (Amendment) Rules, 2023, are introduced.
  • The amendment modifies paragraph 3, sub-paragraph (1), clause (b) of the First Schedule of the New Drugs and Clinical Trials Rules, 2019, concerning development methodology.
  • The updated clause (b) specifies that general requirements for non-clinical studies are outlined in the Second Schedule.
  • It details non-clinical testing methods for evaluating the safety and efficacy of new drugs, including cell-based assays, organ chips and microphysiological systems, sophisticated computer modeling, human biology-based test methods, and animal studies.
  • The notification was published on March 13, 2023, and the rules come into force on the date of their publication in the Official Gazette.

Impact Analysis

Pharmaceutical Companies

  • Action Item: Review and update internal SOPs to align with the new guidelines for non-clinical studies. Assess current capabilities and invest in necessary technologies and training.

Research Institutions

  • Action Item: Develop training programs and research initiatives focused on the new non-clinical testing methods. Foster collaborations with pharmaceutical companies to validate and refine these methods.

Regulatory Agencies

  • Action Item: Update review processes and guidelines to incorporate the new non-clinical testing methods. Provide training to regulatory staff on the evaluation of data from these methods.

Patients

  • Action Item: No direct action needed. The impact on patients is indirect, through improved drug development processes.

Key Entities Referenced

Drugs and Cosmetics Act, 1940: The principal legislation governing drug regulation in India. Sections 12 and 33 of this act provide the central government with the power to make rules for drug regulation. New Drugs and Clinical Trials Rules, 2019: The rules that are being amended by this notification. These rules govern the approval and conduct of clinical trials and the approval of new drugs in India. New Drugs and Clinical Trials (Amendment) Rules, 2023: The current amendment to the New Drugs and Clinical Trials Rules, 2019. Drugs Technical Advisory Board: A statutory body that advises the central government on technical matters related to drugs and cosmetics. Ministry of Health and Family Welfare: The government ministry responsible for health policy in India, including drug regulation.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-13032023-244322 xxxGIDHxxx CG-DL-E-13032023-244322 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.ं 136] नई दिल्ली, सोमवार, माच च13, 2023/फाल्ग नु 22, 1944 No. 136] NEW DELHI, MONDAY, MARCH 13, 2023/PHALGUNA 22, 1944 स्ट्व ास्ट्् य और पररवार कल्य ाण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 9 माच,च 2023 सा. का. जन. 175(अ).—िबदक औषध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा (1) और धारा 33 की उप-धारा (1) के तहत यथाअपेजित, नई औषजध जललजनकल परीिण जनयम, 2019 म ें संिोधन करने के जलए बनाए गए कजतपय जनयमों का मसौिा स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) म ें भारत सरकार की अजधसूचना सं.सा.का.जन.835(अ.) दिनाकं 22 नवंबर, 2022 के द्वारा भारत के रािपत्र, असाधारण, भाग-II, खडं 3, उप-खडं (i) म ें प्रकाजित कराया गया था, साथ ही इससे संभवत: प्रभाजवत होने वाले व्यजियों से आपजियां और सुझाव, उि अजधसूचना से युि सरकारी रािपत्र की प्रजतयां आम िनता के जलए उपलब्ध कराए िान े की तारीख से पंद्रह दिनों की अवजध समाप्त होने से पहल े आमंजत्रत दकए गए थे; और िबदक, उि सरकारी रािपत्र की प्रजतयां आम िनता को 22 नवंबर, 2022 को उपलब्ध कराई गई थीं; और िबदक, उि जनयमों पर आम िनता से प्राप्त आपजियों और सुझावों पर केंद्र सरकार द्वारा जवचार दकया गया ह;ै अब, इसजलए, औषध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 और धारा 33 द्वारा प्रिि िजियों का प्रयोग करत े हुए केंद्र सरकार औषध तकनीकी सलाहकार बोड च के साथ परामिच करने के बाि एतद्द्वारा नई औषजध और जललजनकल परीिण जनयम, 2019 में आग ेसंिोधन करने के जलए जनम्नजलजखत जनयम बनाती ह,ै नामत:- 1. (1) इन जनयमों का नाम नई औषजध और जललजनकल परीिण (.............संिोधन) जनयम, 2023 ह।ै 1636 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] (2) य ेजनयम सरकारी रािपत्र में इनके प्रकािन की तारीख से प्रवृि होंगे। 2. नई औषजध और जललजनकल परीिण जनयम, 2019 म,ें प्रथम अनुसूची के पैरा 3 के उप-परै ा (1) में, तैयार करन े की पद्धजत से संबंजधत खण्ड (ख) के स्ट्थान पर जनम्नजलजखत रखा िाएगा नामत:- “(ख) (I) गरै -जललजनकल अध्ययनों की सामान्य अपिे ाएं जद्वतीय अनुसूची म ें जवजनर्िचष्ट की गई ह।ैं (II) दकसी नई िवा अथवा परीिणाधीन नई िवा की अहाजनकारकता और प्रभावकाररता का आकलन करन े के जलए गैर-नैिाजनक परीिण पद्धजतयों में जनम्नजलजखत िाजमल ह,ैं नामत:- i. सैल-आधाररत मूल्यांकन; ii. ऑगनच जचप्स और माइक्रो दफजियोलॉजिकल प्रणाजलयां; iii. पररष्कृत कंप्यूटर मॉडललगं ; iv. मानव िीव-जवज्ञान आधाररत अन्य परीिण पद्धजतयां; v. पिु अध्ययन”. [फा. स.ं एलस.11014/15/2022-डीआर] रािीव वधावन, सलाहकार (लागत) रटप्पण: नई औषजध और जललजनकल परीिण जनयम, 2019 भारत के रािपत्र, असाधारण, भाग-II, खंड 3, उप-खडं (i) म ें 19 माच,च 2019 की अजधसूचना सं. सा.का.जन.227(अ.) के तहत प्रकाजित हुए थे और जपछली बार 14 अलटूबर, 2022 की अजधसूचना सं. सा.का.जन. 778(अ.) के तहत संिोजधत हुए। MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 9th March, 2023 G.S.R. 175(E).—Whereas a draft of certain rules further to amend the New Drugs and Clinical Trials Rules, 2019, 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. 835 (E), dated the 22nd November, 2022, 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 fifteen days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas, copies of the said Official Gazette were made available to the public on the 22nd November, 2022; And whereas, objections and suggestions received from the public on the said rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the New Drugs and Clinical Trials Rules, 2019, namely:— 1. (1) These rules may be called the New Drugs and Clinical Trials (Amendment) Rules, 2023. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the New Drugs and Clinical Trials Rules, 2019, in the First Schedule, in paragraph 3, in sub paragraph (1), for clause (b), the following shall be substituted, relating to development methodology namely: — “(b) (I) The general requirements of non-clinical studies have been specified in the Second Schedule. (II) The non-clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug include the following, namely: -[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3 (i) Cell-based assay; (ii) Organ chips and micro physiological systems; (iii) Sophisticated computer modeling; (iv) Other human biology-based test methods; (v) Animal Studies.”. [F. No. X.11014/15/2022-DR] RAJIV WADHAWAN, Advisor (Cost) Note: The New Drugs and Clinical Trial Rules, 2019 were published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i) vide Notification Number G.S.R. 227(E), dated the 19th March, 2019 and last amended vide notification number G.S.R. 778(E), dated the 14th October, 2022. 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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