First Time: India releases guidelines on Nanopharmaceuticals; DBT asks for feedback

Nanopharmaceuticals can be targeted to the site of the disease using the nanocarriers, it improves the safety and potency of certain drugs by lowering its dose and, thereby, reducing toxicity.

New Delhi: In a move to boost Nanobiotechnology, the Department of Biotechnology (DBT) has prepared India’s first draft guidelines on the evaluation of Nanopharmaceuticals. DBT has put out the draft for public consultation till March 10 2019.

Nanopharmaceuticals are pharmaceuticals preparation containing nanomaterials intended for internal or external application on the body for the purpose of therapeutics, diagnostics and any health benefit.

These are the products that contain materials in the size scale range of 1 to 100nm in at least in one dimension. The nanocarriers in the drug preparation help improve the safety and potency of certain drugs by lowering its dose and, thereby, reducing toxicity.

Also Read: Arbro Pharma Launches Nanotechnology Based Bioavailable Curcumin

Various scientists/ stakeholders have felt the need to have specific guidelines for evaluation of products in various sector of biological sciences developed through interventions of Nanotechnology.

Accordingly the department, through Indian Society of Nanomedicine has formulated the draft “Guidelines for evaluation of nanopharmaceuticals in India” after a series of consultations with the stakeholders.

Besides assisting the drug controller in evaluating nanopharmaceuticals, the guideline will also guide researchers to get their products approved.

“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 is no nanopharmaceuticals in India but this is a proactive step as research on nanomedicine is on-going,” Renu Swarup, secretary, DBT told HT.

However, Swarup further added, “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.”

Strategically, DBT has initiated funding Research & Development (R&D) in this area since 2007. DBT and the Indian Council of Medical Research (ICMR) have reportedly been funding studies for the formulation of drugs with nanoparticles for cancer, epilepsy, Alzheimer’s disease, pain management and to combat antimicrobial resistance.

DBT had organized an inter-ministerial meeting recently and the draft guidelines have been further revised.

In this regard, DBT invites comments on “Guidelines for evaluation of nanopharmaceuticals in India” from the institutions/ industry/researchers engaged in research & development in Nanobiotechnology.
It is requested that comments/ observations pertaining to the same may be conveyed positively by March 10th, 2019 to nanobiotech.dbt@nic.in

Following pointers are to be taken care of while commenting-

• Mention “Comments on Nano Guidelines” in the subject line.


• Give reference to the page number and para number against your every comment.


• Ensure to mention full name, affiliation and correspondence address at the Email Signature.

Commenting on the same, Dr YK Gupta, the chairperson of the committee that drafted the guidelines told the daily, “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 a 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,”

DBT is mandated to bring out manuals/guidelines specifying procedures that will help in regulatory process pertaining to development/commercialization of Nano products in bio-sectors in India.

Attached below is the draft guidelines for evaluation of nanopharmaceuticals: