Nanopharmaceuticals guidelines have recently been launched by the Indian government. These play a crucial role in the standardization and regulation of nanopharmaceuticals, an emerging sector within the pharmaceutical industry. This article breaks down the importance of these guidelines, how they are defined, and the possible implications they hold for the future of pharmaceuticals.
Nanopharmaceuticals Defined
Nanopharmaceuticals refers to pharmaceutical preparations that utilize nanomaterials. These materials are intended for both internal use and external application on humans for therapeutic, diagnostic, and general health benefit purposes. Particularly, nanomaterial is marked as having a particle size ranging from 1 to 100 nm in a minimum of one dimension. Nanopharmaceuticals are not completely novel drugs but enhanced versions of existing medicines, improved in quality by technological delivery mechanisms, rendering them more effective.
Setting the Standard: Nanopharmaceuticals Guidelines
The newly instituted guidelines align with the provisions laid out in Schedule Y of the Drugs and Cosmetics Rules from 1945, as well as the Second Schedule of the New Drugs and Clinical Trials Rules from 2019, specifically addressing nanopharmaceuticals requirements. Key aspects of the guidelines include insuring particles fit within the declared nano-size range under all testing conditions, revealing in-depth methods of the manufacturing process and the environmental impact of nanomaterial waste disposal, and stating clearly the advantages and potential drawbacks of nanopharmaceuticals compared to conventional/traditional drugs or Active Pharmaceutical Ingredient (API).
Nanocarrier: An innovative module
Nanocarriers, nanomaterials functioning as transport modules for other substances like drugs, along with nanoformulations are considered to demonstrate greater efficacy, lower toxicity, and higher safety than conventional drugs. The guidelines indicate that stability testing for Nanoformulations keep their focus on the functionality, integrity, and size range of nanopharmaceuticals.
Scope of Nanopharmaceuticals
Notably, these guidelines apply not only to nanopharmaceuticals as finished formulations but also to Active Pharmaceutical Ingredient (API) that encompasses both new molecular substances and previously approved molecules with altered nanoscale dimensions and properties.
| Features | Description |
|---|---|
| Nanopharmaceuticals | Pharmaceutical preparations containing nanomaterials |
| Nanomaterial | Material having a particle size ranging from 1 to 100 nm in one dimension |
| Nanocarrier | Nanomaterial used as a transport module for other substances |
Implications and Advantages of Guidelines
The implementation of these guidelines is suggested to reinforce the regulatory system for Nanoformulations. This could serve as an aid to Indian researchers and industry insiders looking to conduct research into nanopharmaceuticals product development and commercialization. Furthermore, such guidelines can pave the way for substantial benefits via this innovative technology, contributing to the mission of ‘Affordable Health Care for All’.
