Rashi Malik and Sharvil Patil* Pages 1 - 12 ( 12 )
Background: The outlook on “Nano-materials, products, medicine and technology” lacks a consensus on definition to be looked upon by regulatory bodies all over the world. Engineered nanoparticles, the formulated products containing nanomaterials are not subject to any precise regulation pertaining to production, handling and labeling till now. Also, Nano medicines holding an immense potential involved in treatment and diagnosis with emerging research, yet; lag behind with unnoticed concerns involved with their safety and toxicity. Therefore, regulatory framework focused with specific guidelines for products with application of nanotechnology are being worked on for extending the immense positive benefits of Nano medicines to the humanity. Regulatory bodies have taken forefront to deal with the risks associated with nanomedicines including United States Environment Protection Agency (EPA) and US Food and Drug Administration (USFDA), the Health and Consumer Protection Directorate of the European Commission(EC).
Objective: To addresses the updated understanding by compiling the guidance of different regulatory bodies, depicting the current status and suggesting future perspectives. Thereby, eliminating the vagueness of nanotechnology in regulatory terms.
Conclusion: Nebulousness continues to prevail considering the regulations and safety of nanomaterials. Therefore, it becomes vital to facilitate the harmonization of assessment practices for nanomaterials with a unanimous opinion. On global level, OECD and its Working Party are dealing with manufactured nanomaterials.
Nanomaterials, Nanotechnology, Regulations, USFDA, European Comission, CDSCO
Department of Drug and Regulatory Affairs, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Erandwane, Pune-411038, Maharashtra, Department of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Erandwane, Pune-411038, Maharashtra