Salient features of the National Guidelines for Gene Therapy Product Development and Clinical Trails

'The National Guidelines for Gene Therapy Product Development and Clinical Trials aim to accelerate the development of advanced therapeutic options for genetic diseases in India. The guidelines define gene therapy products as entities that include a nucleic acid component being delivered by various means for therapeutic benefit to patients. They provide general principles for developing gene therapy products for any human ailment, as well as the framework for human clinical trials that must follow established biomedical research principles. The guidelines cover all areas of gene therapy product production, pre-clinical testing, and clinical administration, including long-term follow-up, and require that all gene therapy research be conducted within their principles in a scientific and ethical manner following regulatory requirements. The guidelines also provide mechanisms for review and oversight, responsibilities of investigators, sponsors, ethics committees, and details on chemistry, manufacturing, and control, quality assurance, product attributes, personnel training, and infrastructure requirements.'