There are no specific guidelines for development and evaluation of nanopharmaceuticals in India. There is a need to formulate comprehensive guideline focusing on the quality, safety and efficacy of nanopharmaceuticals for their therapeutics use.
Keeping this in mind and with an aim of supporting, coordinating and advancing the nanotechnology-based research in India, 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 and Family Welfare have rolled out the first guidelines for the sector ‘Guidelines for Evaluation of Nanopharmaceuticals in India’ on October 24. It is an outcome of all concerned Inter-Ministerial efforts coordinated by DBT.
Releasing the document Dr. Harsh Vardhan, Union Minister for Science & Technology, Earth Sciences and Health & Family Welfare informed that these “Guidelines for Evaluation of Nanopharmaceuticals in India” is one of the most important steps for delineating quality, safety and efficacy assessment of the novel nanoformulations. These guidelines are intended to provide transparent, consistent and predictable regulatory pathways for nanopharmaceuticals in India.”
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