The ministry has launched “Guidelines for Evaluation of Nanopharmaceuticals in India", stating that the general requirements and guidelines specified for approval of manufacture/import of any new drug or to undertake clinical trial as specified in the New Drugs and Clinical Trials Rules, 2019 apply to nanopharmaceuticals also.
The guidelines said the requirement of special or additional tests for safety and efficacy evaluation of a particular nanopharmaceutical should be decided on a ‘case-by-case approach’ which will depend upon various factors such as physiochemical and biological nature, and other aspects, including the background data available on the active pharmaceutical ingredient (API) or nanocarrier, the regulatory status in other countries, etc.
Nanocarrier-based targeted drug delivery is an emerging field with introduction of nanopharmaceuticals in the market. These nanoformulations have higher efficacy, lower toxicity and are safer than conventional drugs.
The guidelines also state that successful translation of nanopharmaceuticals from nonclinical proof of concept to clinics is challenging. Like development of any new drug, it requires effective integration of nanotechnology with chemistry, life sciences and medicine. However, because of complexity in nanotechnology, the system necessitates a ‘case-by-case approach’ with involvement of varied expertise for successful development of nanopharmaceuticals.
“’Guidelines for Evaluation of Nanopharmaceuticals in India’ is one of the most important steps for delineating quality, safety and efficacy assessment of the novel nanoformulations. These guidelines are intended to provide transparent, consistent and predictable regulatory pathways for nanopharmaceuticals in India," Harsh Vardhan, Union Minister for Science & Technology, Earth Sciences and Health & Family Welfare.
The guidelines apply to the nanopharmaceuticals in the form of finished formulation as well as API of a new molecule or an already approved molecule with altered nanoscale dimension, properties or phenomenon associated with the application of nanotechnology intended to be used for treatment, in vivo diagnosis, mitigation, cure or prevention of diseases and disorders in humans
The guidelines would facilitate translational research in line with the regulatory requirements. Guidelines 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 with the guidelines.
“The guidelines 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 the way for significant benefits through such cutting edge technology and contribute to the mission on ‘Affordable Health Care for All’," Harsh Vardhan said.
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