Govt releases guidelines on nanopharmaceuticals evaluation

Union Minister Dr harsh Vardhan releasing Guidelines for Evaluation of Nanopharmaceuticals in India on October 24.

New Delhi (NVI): The Government on October 24, released “Guidelines for Evaluation of Nanopharmaceuticals in India” that will help delineating quality, safety and efficacy assessment of the novel nanoformulations.

Releasing the guidelines here, Minister for Science & Technology, Earth Sciences and Health & Family Welfare, Dr Harsh Vardhan said that these guidelines are intended to provide transparent, consistent and predictable regulatory pathways for nanopharmaceuticals in India.

Nanocarrier based targeted drug delivery, is an emerging field with introduction of nanopharmaceuticals in the market. These nanoformulations have higher efficacy, lower toxicity and safer than the conventional drugs, an official statement said.

Indian researchers would be facilitated to undertake research in line with the regulatory guidelines. Moreover, private investments would also be attracted since these guidelines would strengthen the regulatory system.

The guidelines would facilitate transitional research in line with the regulatory requirements. They will also facilitate the decision making by regulator during clearances to newer products based on nanotechnology and similarly to researchers to get clearance for their products to launch in market. End users will also benefit from the quality assured anticipated products in the market in accordance to the guidelines.

This document will give impetus to initiate activities for developing safety guidelines for other domains like agri-inputs and agri-products, cosmetics, implantable devices, through interventions of nanotechnology.

The guidelines will pave way for significant benefits through such cutting edge technology and contribute to the mission on “Affordable Health Care for All”.

–rb