Guidelines for Evaluation of Nanopharmaceuticals in India

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News:Union Minister for Science & Technology has released the Guidelines for Evaluation of Nanopharmaceuticals in India.


What are Nanopharmaceuticals?

  • 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 higher efficacy, lower toxicity and are safer than the conventional drugs.

Guidelines on Nanopharmaceuticals:

  • These Guidelines were prepared to provide transparent, consistent and predictable regulatory pathways for nanopharmaceuticals in India.
  • They were framed by the inter-ministerial expert committee constituted by the Department of Biotechnology in May 2019.
  • It was prepared in line with the provisions of Schedule Y of Drugs and Cosmetics Rules,1945 as well as Second Schedule of the New Drugs and Clinical Trials Rules, 2019 with specific requirements for nanopharmaceuticals.

Key points of the Guidelines:

  • The impact of nano material waste disposal on environment should be declared.
  • The stability testing for Nanoformulations should focus on functionality, integrity, size range of nanopharmaceuticals.
  • 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 sexes.

Significance of the guidelines:

  • The guidelines will help to facilitate research in line with the regulatory requirements.
  • It will help in making decision in clearing new products based on nanotechnology and would also help in attracting new private investments.
  • It will help to initiate activities for developing safety guidelines for other domains like agri-inputs, cosmetics, implantable devices.
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