A Comparative study of Regulations of Cell and Gene therapy in US, EU and India

  • A Tejaswini
  • N.L. Prasanthi
  • K.Venkateswara Raju PROFESSOR


Cell and Gene therapy products were a field that is growing fast inventive therapies. The United States (US) and the European Union (EU) are encouraging their evolution and India is in its nascent stage. For three regions, CGTs fall beneath the biological merchandise regulatory framework of it requires the legal foundation for their evolution. In the EU, there is a defined trend between cell- and gene-based products concerning their classification as advanced therapies or coverage by the legal frameworks, while in the United States there is a wide classification as to classified as organic products. In EU, USA and India, to allocate a cell or an gene product’s as innovative therapy, care has to be taken for therapy of cells involves manoeuvres that amend their characters which are organic, as the term tactic in the USA is difference between systemic and non- systemic cells and gene therapy products. A descriptive analysis was carried out. Till now in USA 20 CGTPs are approved, out of 20 GTMP consists of 7 and CTMP consists of 13 products. Many products are under clinical trials, I searched clinical trials website to know the status of clinical trials in USA. I found 355 clinical trials under ATMPs, out of 355 GTMP consist of 225, SCTMP consists of 105, and CATMP consists of 25. In India the procedures are of two types which are to speed up the drug approval process for the betterment of everyone. They are 1) Conditional Approval, 2). Fast Track Approval. There are only 4 products were approved namely Apceden, Stempeucel, Ossgrow and Cartigrow. The problems related to clinical has been degenerate as the unproven stem cell clinics numbers in the USA reportedly were increased to approximately 715 by 2017. Therefore, the unproven industry of sanatorium is a moving intention essential in method examine and regulatory lapse.

Keywords: Cell therapy products, Gene therapy products, Gene remedy Advisory and evaluation Committee (GTAEC), CHMP, CBER


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How to Cite
Tejaswini, A., N. Prasanthi, and K. Raju. “A Comparative Study of Regulations of Cell and Gene Therapy in US, EU and India”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 4, Dec. 2022, pp. 88-95, doi:10.22270/ijdra.v10i4.569.

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