CDSCO, DBT and ICMR Joint Guidelines for Evaluation of Nanopharmaceuticals in India

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The guidelines for evaluation of nanopharmaceuticals in India aim to ensure quality, safety, and efficacy of these products. The guidelines define nanopharmaceuticals as pharmaceutical preparations containing nanomaterials intended for internal use or external application on humans. They categorize nanopharmaceuticals based on degradability, organicity, function, and approval status. Biodegradable nanomaterials are preferred due to their better encapsulation, controlled release, improved bioavailability, and reduction of toxic potential.

The guidelines specify requirements for quality, safety, and efficacy data for different categories of nanopharmaceuticals. They also provide considerations for stability testing, animal pharmacology and toxicology data, clinical trial data, information required for evaluation, and pharmacovigilance. The guidelines aim to encourage commercialization of new innovations in the field of nanopharmaceuticals/nanomedicine.

The document was compiled with an aim to ensure quality, safety, and efficacy of nanopharmaceuticals as well as to encourage commercialization of nanotechnology-based inventions by increasing their benefit-to-risk ratio. The guidelines are intended to provide transparent, consistent, and predictable regulatory pathways for nanopharmaceuticals in India.