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Quality Local ProductionTraining Workshop Kathmandu, Nepal, 21–23 May 2024 © World Health Organization 2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGOlicence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the workis appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses anyspecific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you mustlicense your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you shouldadd the following disclaimer along with the suggested citation: “This translation was not created by the World HealthOrganization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shallbe the binding and authentic edition.” Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of theWorld Intellectual Property Organization. Suggested citation.Quality local production training workshop. New Delhi: World Health Organization, Regional Office forSouth-East Asia; 2024. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests forcommercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures orimages, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from thecopyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solelywith the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply theexpression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or ofits authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps representapproximate border lines for which there may not yet be full agreement. The mention of specific companies or of certainmanufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similarnature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initialcapital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, thepublished material is being distributed without warranty of any kind, either expressed or implied. The responsibility for theinterpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Contents Page No. IntroductionOpening remarksPresentations Annexure List of Participants 14 1. Introduction During the Director General (DG) WHO’s and Regional Director (RD) SEARO’s visit toKathmandu, Nepal there was a request from the Ministry of Health and Population, Nepal(MoHP) to improve and facilitate domestic production of essential drugs and surgical careproducts. Hence, a scoping mission was taken up by IPT during 20-24 March 2023, toidentify priority areas for technical support to facilitate domestic production of essentialmedicines in Nepal. Theactivity is in line with the World Health Assembly resolution WHA74.6“Strengthening local production of medicines and other health technologies to improveaccess to medicines and Global Strategy and plan of action on public health, innovation andintellectual property –GSPA-PHI,WHA61.2 – extended inMay 2022until2030. Based on the above, detail deliberations were held with MoHP and WCO Nepalcolleagues during the scoping visit and in consultation with WR Nepal it was decided tosupport a training workshop based on request of Department of Drug Administration (DDA)Nepal. The training workshop training was held in Kathmandu, Nepal from 21 to 23 May2024. WHO Country Office and SEARO was supported by DDA who also engaged withAssociation of Pharmaceutical Producers of Nepal (APPON). This is a report on the activityand resultant outcomes. The main objective of the training workshop was to provide training to manufacturingindustries in Nepal and officials of DDA for: technical support to facilitate domestic production of essential medicines; andcapacity-building of local manufacturers of medicines on cGMP, technologytransfer, WHO prequalification. Based on discussi