The Centre has moved to lay down the law on nanopharmaceuticals, with the release of guidelines at the end of last week to promote them and ensure they are regulated on par with other medicines and medical products.
The ‘Guidelines for Evaluation of Nanopharmaceuticals in India’ were jointly prepared by the Department of Biotechnology under the Union Ministry of Science and Technology and the Central Drugs Standard Control Organisation (CDSCO), and the Indian Council for Medical Research (ICMR) under the Union Ministry of Health and Family Welfare. The guidelines have been issued in the absence of globally accepted guidelines for nanopharmaceuticals contain a number of provisions.
“A nanopharmaceutical is defined as a pharmaceutical preparation containing nanomaterials intended for internal use or external application on humans for the purpose of therapeutics, diagnostics and health benefits,” the Guidelines explain. Nanopharmaceuticals are the subject of much fervour in treatment by the healthcare community.
“There has been a revolution in nanotechnology and nanomedicine,” read a study published last year. “Since 1980, there has been a remarkable increase in approved nano-based pharmaceutical products. These novel nano-based systems can either be therapeutic agents themselves, or else act as vehicles to carry different active pharmaceutical agents into specific parts of the body.”
“Nanopharmaceuticals offer the ability to detect diseases at much earlier stages and the diagnostic applications could build upon conventional procedures using nanoparticles,” writes the Nano Science and Technology Consortium. “Nanopharmaceuticals represent an emerging field where the sizes of the drug particle or a therapeutic delivery system work at the nanoscale.
“In the pharmaceutical industry, a long standing issue is the difficulty of delivering the appropriate dose of a particular active agent to specific disease site. Nanopharmaceuticals have enormous potential in addressing this failure of traditional therapeutics which offers site-specific targeting of active agents. Such precision targeting via nanopharmaceuticals reduces toxic systemic side effects, resulting in better patient compliance.”
Dr Harsh Vardhan, the Union Minister of both Health and Family Welfare and Science and Technology, has expounded upon the potential of nanopharmaceuticals. “Nanocarrier-based targeted drug delivery is an emerging field with introduction of nanopharmaceuticals in the market,” he said at the launch of the guidelines. “These nanoformulations have higher efficacy, lower toxicity and are safer than the conventional [drugs].”
Of the guidelines themselves, Vardhan described their formulation as “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.”
“The Guidelines…are compiled with an aim of evaluation of the pharmaceutical preparations containing nanomaterials,” the editors write in the Guidelines’ preface. “Nanopharmaceuticals need additional tests for ensuring uniform safety and efficacy. The general principle of regulatory [guidelines] for API [active pharmaceutical ingredients] as mentioned in the New Drugs and Clinical Trial Rules 2019 issued by CDSCO has been followed. These guidelines are also aligned with ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] guidelines and international norms followed by other countries commercializing such products.
“The goal of these guidelines is to help the regulators to assess the quality, safety and efficacy of the nanoformulation/nanopharmaceuticals in a systematic manner. It will also guide the innovators and industries to generate the data according to the nanomaterial specific requirements. The current guidelines are applicable to nanopharmaceuticals and not for cosmetics and nanoenabled devices or implants.”
The 2017 National Health Policy reflected the need for stimulation of innovation in the health sector. The enthusiasm of government agencies in the development and regulation of nanopharmaceuticals suggests that the sector will form a part of this way forward.
The ‘Guidelines for Evaluation of Nanopharmaceuticals in India’ can be accessed here.