CELL & Gene therapy is a promising field of biomedical research and improving the safety and efficacy of gene therapy is the need of the hour. The United States and Europe are the pioneers in this field with clinical trials being carried out for more than two decades and India has stepped into it with much more awaiting results. Recently, here has been a surge in the number of gene therapy research activities in India. Ethical issues observed in the past related with the use of gene therapy technologies led to the development of stringent guidelines and regulations to avoid its misuse and premature commercialization. Hence, it is the responsibility of all the stakeholders to develop the strategies for adhering to the national guidelines to make gene therapy a reliable treatment option in future. These guidelines and regulations are dynamic and will have to be looked upon from time to time as per the changing global standards. Elaboration of strategies based on specific genetic diseases will also be a welcoming adds on to the update of the current guidelines.