REGULATORY REQUIREMENTS FOR ORPHAN MEDICINE AS PER CDSCO IN INDIA COMPARISON WITH US AND EUROPE UNION

Ashok Kumar P.*, Meghana, Prakruthi, Deepak, Kowshik S. V. and Anup Kumar M.

ABSTRACT

The project aims to conduct an in-depth analysis and documentation of the regulatory framework governing orphan medicines in India as established by the Central Drugs Standard Control Organization (CDSCO). This comprehensive report is intended to serve as an invaluable resource for pharmaceutical companies, healthcare professionals, regulatory authorities, and other stakeholders involved in the development, approval, and accessibility of orphan medicines in India. The primary purpose of this project, "Regulatory Framework Analysis for Orphan Medicines in India: A CDSCO Perspective," is to conduct an exhaustive examination and documentation of the regulatory landscape governing orphan medicines in India. Specifically, the project focuses on the regulations and guidelines established by the Central Drugs Standard Control Organization (CDSCO). This section of the project report provides a detailed examination of the Central Drugs Standard Control Organization (CDSCO) guidelines related to orphan medicines in India. It covers the definition and criteria for orphan medicines, as well as the designation process for orphan drug status within the CDSCO framework. It's important to note that the criteria for orphan designation may evolve over time as scientific understanding of rare diseases advances and as regulatory authorities like the CDSCO refine their guidelines. These criteria ensure that orphan medicines meet high standards of safety and efficacy while addressing the unique healthcare challenges posed by rare diseases, ultimately aiming to improve the prospects and well-being of rare disease patients in India.

Keywords: Rare diseases, Orphan medicine, CDSCO, Agendas, Union.