National guidelines for gene therapy product (2019)

Abstract

The “National Guidelines for Gene Therapy Product (GTP) Development and Clinical Trials” prepared by the Indian Council of Medical Research and Department of Biotechnology in 2019 came as a welcome step in the process of regulation of gene therapy research, as there was a lack of Indian guidelines earlier specific to gene therapy. Indian researchers have taken their step in setting the path of gene therapy research, and this guideline serves to provide the standards starting from its development up to translation to new drug including the ethical, scientific, and regulatory requirements to be followed during the conduct of trial. The Indian guidelines were framed with reference to United States-Food and Drug Administration and European Union guidelines on gene therapy. It is the responsibility of all the stakeholders involved in the development of GTP to adhere to the national guidelines. This review provides an outline of the Indian regulatory guidelines on GTP.

Knowledge, attitudes and practices of Materiovigilance among physicians in a rural tertiary care teaching hospital in Puducherry- a cross sectional study

“…In a study conducted among staff nurses, 67% knew about the existence of MvPI program, which is higher than that observed in our study [14]. With respect to the correct responses to the knowledge questions, basic knowledge about the materiovigilance program was there in 60% of faculties, but the knowledge regarding the category of medical devices and how and where to report such events is very poor, with only 30-40% of physicians knowledgeable.…”