Regulatory and Ethical Frameworks for First-in-Human Clinical Trials in India: Proceedings of a Codesigned Capacity-Building Workshop.

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Title: Regulatory and Ethical Frameworks for First-in-Human Clinical Trials in India: Proceedings of a Codesigned Capacity-Building Workshop.
Authors: Shafiq N; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India. nusrat.shafiq.pgi@gmail.com., Kumar A; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India., Cherian JJ; Clinical studies and trials Unit, Division of Development Research, Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India.; Health Systems and Policy (HSP), Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.; Faculty of Medical Research, Academy of Scientific and Innovative Research (AcSIR), Ghaziabad, Uttar Pradesh, 201002, India., Madan T; Division of Development Research, ICMR Network for Phase 1 Clinical Trials, CSTU, ICMR HQ, New Delhi, Delhi, 110029, India., Kshirsagar N; Former National Chair Clinical Pharmacology, Division of Basic Medical Sciences, Indian Council of Medical Research, New Delhi, Delhi, 110029, India., Mukherjee A; Clinical studies and trials Unit, Division of Development Research, Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India.; Faculty of Medical Research, Academy of Scientific and Innovative Research (AcSIR), Ghaziabad, Uttar Pradesh, 201002, India.; Wellcome Trust/India Alliance, New Delhi, India., Vij S; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India., Singh PK; Formerly- Senior VP Clinical Trial Management, Lambda Therapeutic Research, Ahmedabad, Gujarat, 382481, India.; Kashiv Biosciences India Pvt. Ltd, Sardar Patel Ring Rd, Ahmedabad, Gujrat, 382210, India., Srivastava G; Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Visala A; Central Drugs Standard Control Organization (CDSCO), FDA Bhavan, ITO, Kotla Road, New Delhi, 110002, India., Kumar A; Aurigene Oncology Limited, Bengaluru, Karnataka, 560100, India., Soman A; Global Regulatory Affairs- CMC, Sun Pharma Advanced Research Co. Ltd. (SPARC), Mumbai, Maharashtra, 400093, India., Kotakonda HK; DMPK & Clinical Pharmacology, Bugworks Research India Pvt Ltd, Bangalore, Karnataka, 560065, India., Joglekar S; Novartis Healthcare Pvt Ltd., Hyderabad, Telangana, 500081, India., Joshi M; Technical Operations, IDRS Labs Pvt Ltd., Bengaluru, Karnataka, 560099, India., Udupa V; Toxicology, Glenmark Pharmaceuticals Limited, Mumbai, Maharashtra, 400026, India., Poomali A; Division of Development Research, ICMR Network for Phase 1 Clinical Trials, CSTU, Indian Council of Medical Research, New Delhi, Delhi, 110029, India., Noronha NB; Division of Development Research, ICMR Network for Phase 1 Clinical Trials, CSTU, Indian Council of Medical Research, New Delhi, Delhi, 110029, India., Gogtay N; Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Mumbai, Maharashtra, 400012, India., Krishnamurthy MN; Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Navi Mumbai, Maharashtra, 410210, India.; Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, 400094, India., Mohapatra S; Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Guwahati, Assam, 781101, India., Saha N; Centre for Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, New Delhi, Delhi, 110062, India., Gota V; Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Navi Mumbai, Maharashtra, 410210, India., Pradhan AK; Advisor to CDSCO, New Delhi, Delhi, 110002, India., Chatterjee P; Cell and Gene Therapy R&D and Process Development, Aurigene Oncology Limited, Bangalore, Karnataka, 560100, India., Kumar A; Novartis Healthcare Pvt Ltd, Hyderabad, Telangana, 500081, India., Chaturvedi A; CSR Delivery and Head-RWS India, Hyderabad, Telangana, 500032, India.; Regulatory Writing and Submissions (RWS), Global Clinical Operations (GCO), Novartis Healthcare Pvt Ltd., Novartis Knowledge city, Hyderabad, Telangana, 500032, India., Balasundaram MK; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India., Prakash G; Department of Clinical Haematology and Medical Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India., Kakkar AK; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India., Malhotra S; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.
Source: Clinical drug investigation [Clin Drug Investig] 2026 Jul; Vol. 46 (7), pp. 683-689. Date of Electronic Publication: 2026 May 26.
Publication Type: Journal Article; Review
Journal Info: Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9504817 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1918 (Electronic) Linking ISSN: 11732563 NLM ISO Abbreviation: Clin Drug Investig Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1179-1918
DOI:10.1007/s40261-026-01558-8