India to promote nano-pharmaceuticals
India has now developed technical guidelines to evaluate nano-pharmaceuticals for regulatory approvals in the country. These guidelines, released by Union Health Minister Harsh Vardhan on Thursday, are expected to help translational research towards the development of novel nano-formulations that are more efficacious, less toxic and safer compared to the conventional drugs.
Nano-formulations are not entirely new drugs but they are the medicines that have better quality. This is because of the technology-led delivery mechanisms that are being used to make its administration in the body a more effective one. There are no internationally accepted uniform guidelines and norms for nano-pharmaceuticals. The usual consensus and factors considered for evaluation are quality, safety, & efficacy of nanotechnology-based products is to have a case-to-case approach. It takes into account the physical, chemical & biological characteristics of the nano-material used and the product, route of administration, the indication for which the product is intended to be used and other related aspects. The Indian
guidelines also advocate a similar approach.The guidelines define the nano-pharmaceuticals and categorize it according to its level of degradability & organic or inorganic nature.
On the conduct of clinical trials for the drug, the guidelines say that while “the general requirements of clinical data & guidelines as specified in the New Drugs and Clinical Trials Rules, 2019 apply to the nano-pharmaceuticals, it should also be demonstrated clinical through appropriate design, patient selection hypothesis & biomarkers to exploit the increased permeability and the retention of the drug”.
While speaking at the launch function, the minister said that the development of cost-effective quality products through innovative research and technologies such as nano interventions could ensure affordable healthcare for all.
The authors of the guidelines say that it was compiled with an aim to evaluate the pharmaceutical preparations that contain nano-materials where the novel application of nanotechnology imparts significant advantages over the existing active pharmaceutical ingredients both in terms of targeted delivery to the disease site, higher efficacy, & lower toxicity.
S Eswara Reddy, Joint Drugs Controller said that the guidelines, a joint effort by the Department of Biotechnology, Research and Central Drugs Standard Control Organisation, Indian Council for Medical become critical as there is no strict regulatory pathway to assess the quality of the product by the health ministry at the moment. “Nano-technology intervention has opened a new horizon for targeted delivery of approved drugs and repurposing of drugs. Every year several new nano-pharmaceuticals are being introduced into the market globally. The guidelines will encourage Indian innovators and industries to develop and commercialize new nano-pharmaceuticals, which will make our country a global leader in this area,” the guidelines state.
Author: Ria Roy
Editor’s Note: India to promote nano-pharmaceuticals, India Develops Regulatory Guidelines To Promote Nano-Pharmaceuticals, expected to help translational research, development of novel nano-formulations that are more efficacious, less toxic and safer compared to the conventional drugs.
