Department of Biotechnology, Government of India and Indian Society of Nanomedicine have jointly prepared the Guidelines for Evaluation of Nanopharmaceuticals in India. This is to ensure the quality, safety and efficacy as well as encourage the commercialization of nanotechnology based innovation with high benefit and low risk ratio.
This is however a proposal made by the Biotechnology Department and has not yet been implemented.
These guidelines would apply to the nanopharmaceuticals in the form of finished formulation as well as API of a new molecule or an already approved molecule with altered dimensions, properties or phenomenon associated with the application of nanotechnology intended to be used for diagnosis, treatment, mitigation or prevention of diseases in human.
Source: Department of Biotechnology, Government of India
