DBT releases guidelines for evaluation of nanopharmaceuticals

Science and Technology Minister Harsh Vardhan on Thursday released guidelines for the evaluation of nanopharmaceuticals, a move that is intended to provide transparent, consistent and predictable regulatory pathways in the area. The guidelines are developed by Department of Biotechnology (DBT), Ministry of Science and Technology, Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare. They are the outcome of inter-ministerial efforts coordinated by the DBT.

Nanocarrier based targeted drug delivery is an emerging field with the introduction of nanopharmaceuticals in the market. These nanoformulations have higher efficacy, lower toxicity and are safer than the conventional drugs. Indian researchers would be facilitated to undertake research in line with the regulatory guidelines and it is expected that industry will be keen to participate from the beginning of the research pipeline towards product development and commercialisation, a statement said.

Speaking at the event, Vardhan said these guidelines are intended to provide transparent, consistent and predictable regulatory pathways for nanopharmaceuticals in India. Further, the guidelines will also attract private investments as they will strengthen the regulatory system, he added.

The guidelines will facilitate translational research in line with the regulatory requirements. They will also facilitate decision-making by regulator during clearances to newer products based on nanotechnology and similarly for researchers to get clearance for their products to launch in market, the statement added.

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