India develops regulatory guidelines to promote nano-pharmaceuticals

India has developed technical guidelines to evaluate nano-pharmaceuticals for regulatory approvals in the country. The guidelines, released by Union Health Minister Harsh Vardhan on Thursday, are expected to aid translational research towards development of novel nano-formulations that are more efficacious, less toxic and safer than conventional drugs.

Nano-formulations are not entirely new drugs but medicines that have better quality because of the technology-led delivery mechanisms that are used to make its administration in the body more effective. There are no internationally accepted uniform guidelines for nano-pharmaceuticals. The usual consensus for evaluation of quality, safety and efficacy of nanotechnology-based products is to have a case-to-case approach. It takes into account the physical, chemical and 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 the similar approach.

The guidelines define the nano-pharmaceuticals and categorise it according to its level of degradability and organic or inorganic nature.

On the conduct of clinical trials, the guidelines say that while "the general requirements of clinical data and 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 and biomarkers to exploit the increased permeability and retention of the drug".

Speaking at the launch function, the minister said that the development of cost effective quality products through innovative technologies such as nano interventions could ensure affordable healthcare for all.

The authors of the guidelines say it was compiled with an aim to evaluate the pharmaceutical preparations containing nano-materials where the novel application of nanotechnology imparts significant advantages over the existing active pharmaceutical ingredients in terms of targeted delivery to the disease site, higher efficacy and lower toxicity.

S Eswara Reddy, Joint Drugs Controller said that the guidelines, a joint effort by the department of biotechnology, Indian Council for Medical Research and Central Drugs Standard Control Organisation, become critical as there is no strict regulatory pathway to assess the quality of the product by the health ministry at the moment. "Nanotechnology 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 commercialise new nano-pharmaceuticals, which will make our country a global leader in this area," the guidelines state.