India’s first draft guidelines on nano-medicines

The department of biotechnology (DBT) has put out India’s first draft guidelines on evaluation of nanopharmaceuticals for public consultation till March 10.

Nanopharmaceuticals are drug preparations that use nanoparticles the size of 1 to 100 nm as carriers for targetted delivery of an active pharmaceutical ingredient. As the drugs can be targeted to the site of the disease using the nanocarriers, it improves the safety and efficacy of certain drugs by lowering its dose and, thereby, reducing toxicity.

“This is a guideline document that will help the drug controller in evaluating nanopharmaceuticals and approving them for use in the Indian market. This document will also guide researchers on how to get their product approved. Currently, there are no nanopharmaceuticals in India but this is a proactive step as research on nanomedicine is on-going,” said Renu Swarup, secretary, DBT.

As part of India’s nano mission, the DBT and the Indian Council of Medical Research (ICMR) have been funding studies for formulation of drugs with nanoparticles for cancer, epilepsy, Alzheimer’s disease, pain management and to combat antimicrobial resistance.

“There are uses in diagnostics etc, which are not covered by these guidelines. The department will work on separate guidelines for diagnostics and applications in agriculture etc,” said Swarup.

“When the drug is in the nanoform, there are changes in pharmacokinetics or how it gets absorbed, distributed in the body, metabolised or excreted. The pharmacodynamics also change, meaning the way it binds with receptors. This may result in change in dosage, unexpected side effects etc.

Hence, there is a need for additional tests apart from the ones mentioned in Schedule Y of the Drugs and Cosmetics Act,” said Dr YK Gupta, the chairperson of the committee that drafted the guidelines.