{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T20:21:37Z","timestamp":1787775697528,"version":"build-2784847793"},"reference-count":8,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The manuscript summarizes the outcomes of a one-day conference by the South Asian College of American College of Clinical Pharmacology (SAC-ACCP) in July 2023, at Bhopal. The theme of the conference was \u201cAdvancing pediatric drug development in South Asia.\u201d SAC-ACCP organized this event in Bhopal to foster the discipline of clinical pharmacology and to motivate researchers and physicians in the in the central part of India. The conference featured presentations on regional approaches to pediatric drug development in Asia by pediatric scientific experts from the pharmaceutical industry, regulatory agencies, as well as independent consultancies. The speakers highlighted several important aspects of the evolving regulatory landscape in India and proposed numerous actionable steps in acceleration of pediatric drug development. This commentary provides insights from presentations and the panel discussion at this conference and also makes an attempt to connect to similar discussions that occurred at the SAC-ACCP drug development conference in 2017.<\/jats:p>","DOI":"10.4103\/ijp.ijp_396_24","type":"journal-article","created":{"date-parts":[[2024,9,9]],"date-time":"2024-09-09T15:17:42Z","timestamp":1725895062000},"page":"285-289","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":0,"title":["Advancing pediatric drug development in South Asia: Current landscape and vision for the future"],"prefix":"10.4103","volume":"56","author":[{"given":"Rajesh","family":"Krishna","sequence":"first","affiliation":[{"name":"Drug Development Solutions, Certara USA, Inc., Princeton, Hillsborough, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manoj","family":"Jadhav","sequence":"additional","affiliation":[{"name":"Clinical Development, ISHA Therapeutics, Hillsborough, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rama","family":"Sivasubramanian","sequence":"additional","affiliation":[{"name":"Clinical Development, Novartis Healthcare Pvt. Ltd, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gangadhar","family":"Sunkara","sequence":"additional","affiliation":[{"name":"Development, Novartis Pharmaceuticals, East Hanover, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vikram","family":"Gota","sequence":"additional","affiliation":[{"name":"Clinial Pharmacology, Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Navi Mumbai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vis","family":"Niranjan","sequence":"additional","affiliation":[{"name":"Translational Medicine, RxMD, Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vipin","family":"Dhote","sequence":"additional","affiliation":[{"name":"Pharmacology, Vidya Niketan Samiti Faculty of Pharmacy, Bhopal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nidhi","family":"Sapkal","sequence":"additional","affiliation":[{"name":"Pharmaceutics, Guru Nanak College of Pharmacy, Nagpur, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nirmala N","family":"Rege","sequence":"additional","affiliation":[{"name":"Pharmacology, Seth GS Medical college and KEM Hospital, Mumbai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samir","family":"Sethi","sequence":"additional","affiliation":[{"name":"Advocacy, Indian Rett Syndrome Foundation, Post Graduate Institute of Medical Education & Research, Chandigarh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bikash","family":"Medhi","sequence":"additional","affiliation":[{"name":"Pharmacology, Post Graduate Institute of Medical Education & Research, Chandigarh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nilima","family":"Kshirsagar","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Indian Council of Medical Research, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deven","family":"Parmar","sequence":"additional","affiliation":[{"name":"Development, Zydus Pharmaceuticals, Pennington, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2024,9,10]]},"reference":[{"key":"R1-20240909","doi-asserted-by":"crossref","first-page":"943","DOI":"10.1002\/jcph.916","article-title":"Regulatory and ethical issues in pediatric clinical research:Recommendations from a panel discussion","volume":"57","author":"Kshirsagar","year":"2017","journal-title":"J Clin Pharmacol"},{"key":"R2-20240909","year":"2002","journal-title":"Best Pharmaceuticals for Children Act. Proceedings of the 107th Congress of the United States of America, Washington, D.C., USA"},{"key":"R3-20240909","year":"2003","journal-title":"Pediatric Research Equity Act of 2003. Proceedings of the 108th Congress of the United States of America, Washington, D.C., USA"},{"key":"R5-20240909","article-title":"International Conference on Harmonization","year":"2022","journal-title":"ICH-E11 A on Pediatric Extrapolation Step 2b"},{"key":"R6-20240909","article-title":"Ministry of Health and Family Welfare, 2021","year":"2021","journal-title":"National Health Policy"},{"key":"R7-20240909","article-title":"World Health Organization Essential Medicines list Avialable from: WHO Model List of Essential Medicines - 23rd list","year":"2023"},{"key":"R9-20240909","article-title":"International Conference on Harmonization ICH E11 (R1) Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population Step 5"},{"key":"R10-20240909","first-page":"e35340","article-title":"Indian essential medicine list for children: Time to revisit","volume":"15","author":"Singhal","year":"2023","journal-title":"Cureus"}],"container-title":["Indian Journal of Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.4103\/ijp.ijp_396_24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T19:39:27Z","timestamp":1787773167000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.4103\/ijp.ijp_396_24"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7]]},"references-count":8,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024]]}},"URL":"https:\/\/doi.org\/10.4103\/ijp.ijp_396_24","relation":{},"ISSN":["0253-7613","1998-3751"],"issn-type":[{"value":"0253-7613","type":"print"},{"value":"1998-3751","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7]]},"assertion":[{"value":"2024-05-13","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-08-12","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}