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The Union Minister for Health released “Guidelines for Evaluation of Nanopharmaceuticals in India”. The Guidelines are developed by Department of Biotechnology (DBT), Ministry of Science and Technology, Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO), Ministry of Health. The guidelines apply to the nanopharmaceuticals in the form of finished formulation as well as Active Pharmaceutical Ingredient (API) of a new molecule or an already approved molecule with altered nanoscale dimensions intended to be used for treatment or prevention of diseases. These guidelines are intended to provide transparent regulatory pathways for nanopharmaceuticals in India. It would facilitate translational research in line with the regulatory requirements.

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