Regulatory Pathway for Registration of ORS with Zinc in Domestic Market and its Comparison with African Countries and The Regulatory Perspective of Real-World Data in the US, Europe, and the UK

Abstract

This work examines the regulatory pathway for registration and dossier filing of ORS with Zinc in the domestic market and compares it with various African countries. The study concludes that the regulatory pathway for the registration of ORS with Zinc in India is more streamlined and efficient than that of African countries. This work also examines how the FDC-Fixed Dose Combination registration and approval process takes place in India. Here FDC used is ORS with Zinc. Basically, Zinc with ORS is more effective than ORS alone as this combination helps prevent diarrhoea by restoring immunity in malnourished children, it also reduces the risk of recurrent diarrhoeal episodes. There are certain regulatory provisions and rules governing FDCs in India and a checklist for the data requirements for approval of FDCs that needs to be followed when registering in the SUGAM portal. This work also focuses on the registration process of FDC in various African markets. In Africa, access to water, sanitation, and hygiene is poor and the burden of diarrhoea is countless relative to the rest of the world. A comparative analysis of the regulatory processes, requirements, and harmonization efforts across these regions can provide valuable insights and identify opportunities for further streamlining and collaboration.