As of 4 October 2019, the UNFPA Expert Review Panel (ERP) for RH medicines has awarded a Category 2 rating for Incepta Pharmaceuticals Ltd. (Bangladesh) intramuscular (IM) depot medroxyprogesterone acetate (DMPA) 150mg/ml product. The UNFPA ERP is an independent advisory body of technical experts coordinated by the WHO that assesses quality risks of pharmaceutical products that do not meet all stringent quality requirements. Products are classified in categories 1 through 4, with categories 1 and 2 signifying that there is no objection to time-limited procurement. The list of current ERP-approved product is available here.
The list of generic quality-assured DMPA-IM products available for procurement also includes one prequalified product manufactured by Mylan (India) and another with an ERP category 1/2 rating manufactured by PT Tunggal (Indonesia). This approval for procurement of an additional generic 3-monthly injectable contraceptive is timely considering the current issues relating to supply shortages from Pfizer for the innovator product, Depo-Provera, that are impacting the global RH community.
Concept Foundation has been working in partnership with Incepta towards WHO-PQ of their DMPA-IM product since 2013 as part of its Bill & Melinda Gates Foundation (BMGF) funded programme entitled ‘Addressing the barriers to making quality assured 3 monthly injectable contraption more widely available’ which focused on provision of technical support to a number of manufacturers of generic DMPA-IM to achieve WHO-PQ. This ERP recommendation reflects the meeting of a major milestone for this programme, and for the Incepta and Concept Foundation teams who have been working hard over the last 5 years to ensure the product meets International Quality Assurance standards. Concept Foundation congratulates the Incepta team and those colleagues for a great achievement.