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Date: 12-Mar-2025 Category: Extra Ordinary State: Union Government Country: India

Reconstitution of the Drugs Technical Advisory Board

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 S.O. 1159(E) dated March 12, 2025, issued by the Ministry of Health and Family Welfare, announces the reconstitution of the Drugs Technical Advisory Board.
  • This reconstitution is done in exercise of the powers conferred by sub-sections (1) and (2) of section 5 of the Drugs and Cosmetics Act, 1940.
  • The notification supersedes the earlier notification S.O. 4326(E) dated October 18, 2021, with the exception of actions already taken or omitted before this supersession.

Key Changes

  • The Drugs Technical Advisory Board is reconstituted with a list of 18 members.
  • The board includes ex-officio members like the Director General of Health Services, the Drugs Controller of India, and Directors of various research institutes and laboratories.
  • The board also includes nominated members from Food and Drugs Administration of Goa, Drugs Control Administration of Himachal Pradesh, Government Analysts from Andhra Pradesh and Uttar Pradesh.
  • The board also has elected members from Pharmacy Council of India, Indian Council of Medical Research, Narendra Modi Medical College, Indian Pharmaceutical Association and others.
  • The Drugs Controller of India will serve as the Member-Secretary of the Board.

Impact Analysis

Pharmaceutical Companies

  • Action Items: Pharmaceutical companies should closely monitor the board's recommendations and engage with board members to provide industry perspectives on relevant issues. They should also prepare for potential changes in regulations based on the board's advice.

Healthcare Providers

  • Action Items: Healthcare providers should stay informed about the board's activities and any resulting changes in drug regulations. They should also participate in consultations and provide feedback on drug-related issues.

Consumers

  • Action Items: Consumers should be aware of the regulatory framework and report any concerns about drug quality or safety to the appropriate authorities.

Government Agencies

  • Action Items: The Ministry of Health and Family Welfare should ensure that the reconstituted board operates effectively and efficiently. They should also provide the necessary resources and support for the board's activities.

Research Institutions

  • Action Items: Research institutions should actively contribute to the board's deliberations and provide evidence-based recommendations on drug-related issues.

Key Entities Referenced

Drugs Technical Advisory Board: A statutory body reconstituted by the Central Government to advise on technical matters related to drugs and cosmetics. Drugs and Cosmetics Act, 1940: The principal legislation governing the regulation of drugs and cosmetics in India. Section 5 empowers the Central Government to constitute the Drugs Technical Advisory Board. Ministry of Health and Family Welfare: The government ministry responsible for health policy in India, including the regulation of drugs and cosmetics. Notification S.O. 4326(E) dated October 18, 2021: The earlier notification that is being superseded by this new notification, except for actions already taken or omitted.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-13032025-261584 CG-DxLx-xEG-I1D3H0x3x2x0 25-261584 xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 1146] नई दिल्ली, बुधवार, माच च12, 2025/फाल्ग नु 21, 1946 No. 1146] NEW DELHI, WEDNESDAY, MARCH 12, 2025/PHALGUNA 21, 1946 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य एव ं पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 12 माच,च 2025 का.आ. 1159(अ).—औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23), जिस े इसम ें इसके बाि 'अजधजनयम' कहा िाएगा, की धारा 5 की उप-धारा (1) और (2) द्वारा प्रित्त िजियों का प्रयोग करत ेहुए और भारत सरकार के स्ट्वास्ट््य और पररवार कल्याण मंत्रालय की अजधसूचना संख्या का. आ. 4326(अ) दिनांक 18 अक्टूबर, 2021 का अजधक्रमण करत े हुए , ऐस े अजधक्रमण स े पहल े की गई या दकए िाने स े छूटी हुई बातों को छोड़कर, केंद्र सरकार एतद्द्वारा औषजध तकनीकी सलाहकार बोडच का पनु गठच न करती ह,ै जिसम ेंजनम्नजलजखत सिस्ट्य िाजमल होंगे, अर्ाचत्: - 1699 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] क्रम संख्या सदस्य का नाम/आधिकारिक पदनाम औषधि तकनीकी औषधि एव ंप्रसािन सामग्री सलाहकाि बोर्ड म ें अधिधनयम, 1940 की िािा धिसके धस्िधत. अंतर्तड धनयक्तु , नाम ननर्देनित या धनवाडधित ककया गया ह।ै (1) (2) (3) (4) 1. स्वास््य सेवाएं महाधनदेशक, नई अध्यक्ष पदेन अधिधनयम की िािा 5 की उपिािा कदल्ली (2) के खंर् (i) के अंतर्डत धनयक्तु ककया र्या। 2. औषधि धनयंत्रक, भाित, नई कदल्ली सदस्य पदेन अधिधनयम की िािा 5 की उपिािा (2) के खंर् (ii) के अतं र्तड धनयक्तु ककया र्या। 3. धनदेशक, केंद्रीय औषधि प्रयोर्शाला, सदस्य पदेन अधिधनयम की िािा 5 की उपिािा कोलकाता। (2) के खंर् (iii) के अंतर्डत धनयक्तु ककया र्या। 4. धनदेशक, केंद्रीय अनुसिं ान संस्िान, सदस्य पदेन अधिधनयम की िािा 5 की उपिािा कसौली। (2) के खंर् (iv) के अंतर्डत धनयक्तु ककया र्या। 5. धनदेशक, भाितीय पशु धिककत्सा सदस्य पदेन अधिधनयम की िािा 5 की उपिािा अनुसंिान सस्ं िान, इज्जतनर्ि, बिेली, (2) के खंर् (v) के अतं र्तड धनयक्तु उत्ति प्रदेश। ककया र्या। 6. अध्यक्ष, िाष्ट्रीय आयुर्वडज्ञान आयोर्, सदस्य पदेन अधिधनयम की िािा 5 की उपिािा भाित (2) के खंर् (vi) के अंतर्डत धनयक्तु ककया र्या। 7. अध्यक्ष, भाितीय भेषि परिषद सदस्य अधिधनयम की िािा 5 की उपिािा पदेन (2) के खंर् (vii) के अंतर्डत धनयक्तु ककया र्या। 8. धनदेशक, केंद्रीय औषधि अनुसंिान सदस्य पदेन अधिधनयम की िािा 5 की उपिािा संस्िान, लखनऊ (2) के खंर् (viii) के अिीन धनयक्तु ककया र्या। 9. धनदेशक, खाद्य एव ंऔषधि प्रशासन सदस्य अधिधनयम की िािा 5 की उपिािा धनदेशालय (2) के खंर् (ix) के अंतर्डत नाम ननर्देनित । 10. औषधि प्रशासन, र्ोवा सदस्य अधिधनयम की िािा 5 की उपिािा (2) के खंर् (ix) के अंतर्डत नाम ननर्देनित । 11. िाज्य औषधि धनयंत्रक, औषधि धनयंत्रण सदस्य अधिधनयम की िािा 5 की उपिािा प्रशासन, धहमािल प्रदशे (2) के खंर् (x) के अतं र्तड धनवाधड ित।[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3 12. र्ॉ. अतलु कुमाि नासा, सदस्य, सदस्य अधिधनयम की िािा 5 की उपिािा कायडकािी सधमधत, भाितीय भषे ि (2) के खंर् (xi) के अिीन धनवाडधित। परिषद 13. श्री सुदशडन िैन, महासधिव, इंनियन सदस्य अधिधनयम की िािा 5 की उपिािा फामाडस्युरिकल (2) के खंर् (xii) के अंतर्डत नाम एलायंस ननर्देनित 14. र्ॉ. िेरिन िोस िेरियन, वैज्ञाधनक-ई, सदस्य अधिधनयम की िािा 5 की उपिािा भाितीय आयुर्वडज्ञान अनुसंिान (2) के खंर् (xiii) के अतं र्तड परिषद धनवाडधित। 15. र्ॉ. भावेश व्यास, सहायक प्रोफेसि, सदस्य अधिधनयम की िािा 5 की उपिािा फामाडकोलॉिी धवभार्, निेंद्र मोदी (2) के खंर् (xiv) के अंतर्डत मेधर्कल कॉलेि, अहमदाबाद, र्ुििात धनवाडधित। 16. र्ॉ. आिएन र्ुप्ता, िाष्ट्रीय अध्यक्ष, सदस्य अधिधनयम की िािा 5 की उपिािा इंधर्यन फामाडस्युरिकल एसोधसएशन (2) के खंर् (xv) के अतं र्तड धनवाडधित। 17. सिकािी धवश्लेषक, औषधि धनयत्रं ण सदस्य अधिधनयम की िािा 5 की उपिािा प्रयोर्शाला, धवियवाडा, आंध्र प्रदेश। (2) के खंर् (xvi) के अंतर्डत नाधमत। 18. सिकािी धवश्लेषक, सिकािी लोक सदस्य अधिधनयम की िािा 5 की उपिािा धवश्लेषक प्रयोर्शाला, लखनऊ, उत्ति (2) के खंर् (xvi) के अंतर्डत नाधमत। प्रदेश। 2. औषजध जनयंत्रक (भारत) बोडच के सिस्ट्य-सजचव होंगे। [फा. सं. एक्स.19012/2/2009-डीएफक्यूसी(भाग)] जनजखल गिराि, संयक्ु त सजचव MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 12th March, 2025 S.O. 1159(E).—In exercise to the powers conferred by sub-sections (1) and (2) of section 5 of the Drugs and Cosmetics Act, 1940 (23 of 1940) hereinafter referred to as ‘the Act’ and in supersession of the notification of the Government of India in the Ministry of Health & Family Welfare, Number S.O. 4326(E) dated the 18th October, 2021, except as respects things done or omitted to be done before such supersession, the Central Government hereby reconstitutes the Drugs Technical Advisory Board consisting of the following members, namely: -4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] Serial Name/Official designation of the Status in Drugs Section of the Drugs and Cosmetics Number. Member. Technical Act, 1940 under which appointed, Advisory Board. nominated or elected. (1) (2) (3) (4) 1. The Director General of Health Chairman Appointed under clause (i) of sub Services, New Delhi. ex- officio section (2) of section 5 of the Act. 2. The Drugs Controller, India, New Delhi. Member Appointed under clause (ii) of sub ex- officio section (2) of section 5 of the Act. 3. The Director, Central Drugs Laboratory, Member Appointed under clause (iii) of sub Kolkata. ex- officio section (2) section 5 of the Act. 4. The Director, Central Research Institute, Member Appointed under clause (iv) of sub Kasauli. ex- officio section (2) section 5 of the Act. 5. The Director, Indian Veterinary Member Appointed under clause (v) of sub Research Institute, Izatnagar, Bareilly, ex- officio section (2) section 5 of the Act. Uttar Pradesh. 6. The Chairman, National Medical Member Appointed under clause (vi) of sub Commission, India. ex- officio section (2) section 5 of the Act. 7. The President, Pharmacy Council of Member Appointed under clause (vii) of sub India. ex- officio section (2) section 5 of the Act. 8. The Director, Central Drugs Research Member Appointed under clause (viii) of sub Institute, Lucknow. ex- officio section (2) section 5 of the Act. 9. Director, Directorate of Food and Member Nominated under clause (ix) of sub Drugs Administration, Goa. section (2) section 5 of the Act. 10. State Drugs Controller, Drugs Control Member Nominated under clause (ix) of sub Administration, Himachal Pradesh. section (2) section 5 of the Act. 11. Dr. Atul Kumar Nasa, Member, Member Elected under clause (x) of sub Executive Committee, Pharmacy section (2) section 5 of the Act. Council of India. 12. Dr. Vijay Oza, Member, Post Graduate Member Elected under clause (xi) of sub Medical Education Board, National section (2) section 5 of the Act. Medical Commission. 13. Shri Sudarshan Jain, Secretary General, Member Nominated under clause (xii) of sub Indian Pharmaceutical section (2) of section 5 of the Act. Alliance. 14. Dr. Jerin Jose Cherian, Scientist- E, Member Elected under clause (xiii) of sub Indian Council of Medical Research. section (2) of section 5 of the Act. 15. Dr. Bhavesh Vyas, Assistant Professor, Member Elected under clause (xiv) of sub Department of Pharmacology, Narendra section (2) of section 5 of the Act. Modi Medical College, Ahmedabad, Gujarat. 16. Dr. R.N. Gupta, National President, Member Elected under clause (xv) of sub Indian Pharmaceutical Association. section (2) of section 5 of the Act. 17. Government Analyst, Drugs Control Member Nominated under clause (xvi) of sub Laboratory, Vijayawada, Andhra section (2) of section 5 of the Act. Pradesh. 18. Government Analyst, Government Member Nominated under clause (xvi) of sub Public Analyst Laboratory, Lucknow, section (2) of section 5 of the Act. Uttar Pradesh. 2. The Drugs Controller (India) shall be the Member-Secretary of the Board. [F. No. X.19012/2/2009-DFQC(Pt.)] NIKHIL GAJRAJ, Jt. Secy. 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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