Guidelines for Nanopharmaceutical Products for Regulatory Approval

Abstract

The word 'nano' refers to a Greek prefix that means  'dwarf' or very little,' and represents a thousand  millionth of a meter (10-9) in length. Nanoscience and  nanotechnology are the study and application of  nanoscale range materials. Initially, the term  Nanotechnology was used by N. Taniguchi in 1974 at an  international conference on industrial production in  Tokyo to characterize the super-thin processing of  materials with nanometre accuracy and the fabrication of  nano-sized systems (Bayda S. et al., 2020). The usage of  nanomaterials has enhanced the application of  nanomedicine in various therapeutics area with  challenges and limitations over the last ten years.  Alteration of the physiochemical, biological, mechanical  & other properties of the materials made the  nanomaterials and it can be utilized in different useful  activities such as drug development, drug target.  Nanotechnology utilized novel nanomaterials to make  useful products. This technology has been used to  overcome the limitations & challenges in different drug  therapies. (Harea JI et al., 2017).  

 The combination of nanotechnology with  pharmaceuticals and biomedicals is termed nano  pharmaceutical. Nanopharmaceuticals is a new  technology in current practice. As a result, there are no  widely agreed nanopharmaceuticals guidelines. The  general idea of regulatory requirements for Active  Pharmaceutical Ingredients (API), as stated in the  CDSCO's New Drugs and Clinical Trial Rules 2019, was  mandatory in drug development pathways. These criteria  are also in line with the International Council for  Harmonization (ICH) recommendations and  international standards that other countries using such  items follow. New Drugs and Clinical Trials Rules, 2019  should be followed in different drug development. (Harea  JI et al., 2017).  

 Globally, there are important guidelines developed by  the United States Food & Drugs Administration  (USFDA), International Council for Harmonization  (ICH), or Organization for Economic Co-operation and  Development (OECD). (Harea JI et al., 2017).  

 Current regulatory approaches by US Food & Drug  Administration (FDA), established the nanotechnology  task force in August 2006. This regulatory approach  encourages the development of nanoproducts. FDA has  issued the guidelines in 2007 to the industry to address  the benefits & risks of Drugs, medical devices, and other  nanoproducts. FDA is also working with other U.S.  government agencies to focus on the safety & efficacy of  nanoproducts and U.S. initiates the National  Nanotechnology Initiative (NNI) which is a federal  research & development program to coordinate the effort  of all government agencies involved in nanotechnology.  The main goal of the NNI is to maintain the class of  research & development program, encourage inducing  the new technologies in the product, developing the supporting infrastructure & tools needed for  nanotechnology (Ventola et al., 2012).