What to study?
For Prelims: Nanopharmaceuticals- meaning and features.
For Mains: The need for, significance of the technology, challenges involved and the overview of guidelines.
Context: Guidelines Released for Evaluation of Nanopharmaceuticals in India.
Guidelines are developed by DBT, ICMR and Central Drugs Standard Control Organization (CDSCO).
Developed in line with the provisions of Schedule Y of Drugs and Cosmetics Rules, 1945 as well as Second Schedule of the New Drugs and Clinical Trials Rules, 2019 with specific requirements for nanopharmaceuticals.
Need for these guidelines:
Nanocarrier based targeted drug delivery is an emerging field with introduction of nanopharmaceuticals in the market. These nanoformulations have higher efficacy, lower toxicity and are safer than the conventional drugs.
Therefore, to provide transparent, consistent and predictable regulatory pathways for nanopharmaceuticals in India these guidelines were necessary.
Application of these guidelines:
The guidelines apply to the nanopharmaceuticals in the form of finished formulation as well as Active Pharmaceutical Ingredient (API) of a new molecule or an already approved molecule with altered nanoscale dimensions, properties or phenomenon associated with the application of nanotechnology intended to be used for treatment, in vivo diagnosis, mitigation, cure or prevention of diseases and disorders in humans.
- These guidelines mark one of the most important steps for delineating quality, safety and efficacy assessment of the novel nanoformulations.
- The guidelines will pave the way for significant benefits through such cutting edge technology and contribute to the mission on “Affordable Health Care for All”.
- Private investments would also be attracted since these guidelines would strengthen the regulatory system.
What are Nanopharmaceuticals?
They are a relatively new class of therapeutic-containing nanomaterials that often have unique ” nanoproperties” (physiochemical properties) due to their small size (compared with their bulk-phase counterparts) a high surface-to-volume ratio and the possibility of modulating their properties.
- Nanopharmaceuticals present novel reformulation opportunities for active agents (e.g., single molecule drugs, proteins, nucleic acids, etc.) that were previously insoluble or could not be targeted to a specific site of the body where they were needed.
- Nanopharmaceuticals can also increase drug half-life by reducing immunogenicity and diminishing drug metabolism.
- With these advantages, nanopharmaceuticals have the ability to extend the economic life of proprietary drugs, thereby creating additional revenue streams.