Comparative Regulatory Requirements for the Stem Cells and Stem Cells Based Products in India, United States and European Union

Abstract

: Stem cells are the unique cells in the body which have the capability to divide continuously and differentiate into various other kinds of cells and tissues. This work represents the issues and challenges in the stem cells and stem cells-based products regulations and compares the related guidelines in India, the USA, and the EU. In India, stem cells (SCs) and stem cells-based products (SCBP) are considered as ‘drugs’ as per the recent guidelines and amendments in the Indian Drugs and Cosmetics Act with a view to streamline the regulatory framework for advanced research. The United States Food and Drug Administration (USFDA) and the Centre for Biologics Evaluation and Research (CBER) in America regulate stem cells and stem cell therapies-based products. European regulation 1394/2007 was issued in 2008, which lays down the legal framework for cell- derived medicinal products in Europe. In the present review, India, USA and EU guidelines have been compared and critically evaluated. After the comparison of the drug approval process in India, the USA and the EU, it was found that India and the USA both have a single registration process for the approval of the drug products, while the EU has multiple processes. The product approval time is more in the USA. EU charges more fees compared to the other countries. Previously, India was following paper CTD formats, but now India is following eCTD, which is also followed by US and EU countries.