Guidelines for evaluation of Nano Pharmaceuticals released

Ministry of Science and Technology issued the “Guidelines for the Evaluation of Nano pharmaceuticals in India” on October 24, 2019. This is the most crucial step for delineating quality, safety and efficacy assessment of the novel nano formulations. The guidelines are important as they help to provide predictable regulatory pathways and transparency for nano pharmaceuticals in India.

The guidelines were framed by the inter-ministerial expert committee constituted by Department of Biotechnology in May 2019.

Key points of the Guidelines

  • The impact of nano material waste disposal on environment should be declared
  • The guidelines have been prepared for finished formulation and API-Active Pharmaceutical Ingredients.
  • It makes it compulsory for the pharma companies to present the data on how the plasma, off-target tissue and disease sites are affected by repeated dosing
  • It provides guidelines for animal toxicology data. It allows the toxicology studies to be performed only on rodent species and dogs in both the sexes.
  • The guidelines have been provided for information on the ingredients, physio chemical characterization data on nano pharmaceuticals, waste disposals, nano carriers, stability studies and analytical method validations.

Significance

  • The guidelines will help to facilitate transitional research in line with regulatory requirements.
  • It will help in making decision in clearing new products based on nano technology
  • It will help to initiate activities for developing safety guidelines for other domains like agri-inputs, cosmetics, implantable devices, etc
  • As the regulatory system of nano pharmaceuticals are strengthened it would attract private investments.

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