Nanosafety — Tech Evolutions

Entry	Year	Description	Impact
CDSCO Guidance for Industry on Nanomaterials in Drug Products	2020	This guidance document, while not an 'amendment' to an act, represents a significant regulatory update by the Central Drugs Standard Control Organization. It provides specific requirements for the regulatory approval of nano-enabled drug products in India, detailing characterization, quality control, and non-clinical and clinical safety data expectations.	It provides a clearer regulatory pathway for pharmaceutical companies developing nanomedicines, enhancing patient safety and bringing India's framework closer to international standards for nano-drugs.
BIS Adoption of ISO Standards for Nanotechnology	Ongoing (e.g., IS/ISO 10808:2010)	The Bureau of Indian Standards (BIS) continuously adopts and adapts international ISO standards related to nanotechnology, such as those for terminology, characterization, and health and safety. These adoptions effectively 'amend' or expand the national standardization landscape for nanomaterials.	This helps in standardizing the nomenclature, measurement, and safety assessment protocols for nanomaterials in India, facilitating trade, research, and regulatory compliance by providing a common technical language and methodology.