From UPSC perspective, the following things are important :
Prelims level : Nano-pharmaceuticals
Mains level : Nano-pharmaceuticals and their applications
- The Ministry of Health and Family Welfare released guidelines for evaluation of nano-pharmaceuticals, which are emerging as more potent tools for treating various diseases.
What are Nano-pharmaceuticals?
- Nanopharmaceuticals represent an emerging field where the sizes of the drug particle or a therapeutic delivery system work at the nanoscale.
- They are derived by application of nanotechnology in medical therapeutics.
- In the pharmaceutical industry, a long-standing issue is a difficulty of delivering the appropriate dose of a particular active agent to specific disease site.
- Nanopharmaceuticals have enormous potential in addressing this failure of traditional therapeutics which offers site-specific targeting of active agents.
- Such precision targeting via nanopharmaceuticals reduces toxic systemic side effects, resulting in better patient compliance.
- They are expected to bring about a revolution in treatment strategies as they would enable targeting specific delivery of drugs and therapeutic molecules.
- They offer higher efficacy and lower toxicity in many disease conditions.
- They are expected to be of great use particularly in cancer treatment.
Why need guidelines?
- Every year several new nano-pharmaceuticals are being developed and marketed across the world.
- India too has a sizable pool of nano-scientists generating a large number of scientific publications in this domain.
- However, regulatory approval is the most important factor for translating laboratory research into bedside medicine.
- The new set of guidelines is designed to facilitate this process.
About the guidelines
- The guidelines cover all the aspects of evaluation from the definition and categorization of nano-pharmaceuticals to pharmacovigilance of the new set of therapeutics.
- It has been prepared as a joint project by the Department of Biotechnology (DBT) in the Union Ministry of Science and Technology, and ICMR and Central Drugs Standard Control Organisation under health Ministry.
- It will give a big boost to innovators and drug manufacturers to optimise their research and come out with medicines that would be safer and more affordable.