- East Asia and the Pacific
- Asia
- Supply and manufacturing
- Guidance document
A review of the internationally accepted UNIMMAP MMS formulation, manufacturing and packaging standards was conducted in 2023 through a collaboration among the Ministry of Health, Republic of Indonesia (MOH), PHARCI, The Vitamin Angel Alliance, and Kirk Humanitarian. This review is based primarily on the specification for UNIMMAP MMS promulgated in the Expert Consensus on an Open-Access UNIMMAP MMS Product Specification, Version 3 (referred to herein as the “Consensus Specification”), which incorporates elements of UNICEF’s specification for the same product to ensure consistency across specifications. The author was given an advanced review copy of the Consensus Specification which will appear as a peer reviewed publication in the third quarter of 2024 in the Annals of the New York Academy of Sciences. The author also had access to all relevant health supplement regulatory and standard requirements established by the MOH, the Indonesian Food and Drug Authority (BPOM), and the Institute of Medicine (IOM), a private, nonprofit unit of the U.S. National Academy of Sciences.
The purpose of this manuscript is to provide recommendations to policymakers, based on a review of the relevant Indonesian regulatory requirements and technical specifications and standards for manufacturing the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) formulation for a multiple micronutrient supplement (MMS) for use in Indonesia.
The recommendations presented herein pertain to UNIMMAP MMS’s product formulation; product description; ingredients, stability studies; packaging; manufacturing standards and certificates; finished product specifications; analytical test methods; storage and transportation requirements; recommended daily allowance (RDA) calculations, with comparisons to upper intake limits; and current benchmark pricing. The recommendations include input from experts at MOH, BPOM, and Indonesian universities.
Recommended UNIMMAP MMS standards/specifications are presented to facilitate the formation and interpretation of future technical guidance that may be provided by BPOM when granting permission to manufacturers to register the UNIMMAP MMS product for use in Indonesia. The aim of the national government should be to replace iron and folic acid tablets or IFA tablets with UNIMMAP MMS for health purposes in accordance with the product specification recommended in this document. This is consistent with the World Health Organization (WHO) policy guidance which recommends context-specific use of UNIMMAP MMS. UNIMMAP MMS is included in the WHO Model List of Essential Medicines.
Consequently, UNIMMAP MMS (NB. MMS and UNIMMAP MMS mean the UNIMMAP formulated multiple micronutrient supplement unless stated otherwise) is recommended to be considered for inclusion in the Indonesian National List of Essential Medicines (DOEN), and eventually on the Indonesian National Formulary to ensure better fulfillment of nutritional needs for pregnant women and their fetuses in Indonesia.