Guidelines Current Affairs - 2020

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Five Documents developed by UGC released

On December 26, 2019, the Union Human Resource Development Ministry released five documents that were developed by UGC covering five verticals of quality mandate. The documents covered eco-friendly and sustainable university campuses, evaluation reforms, human values and professional ethics, academic research integrity and faculty induction.

Highlights

The document provides new guidelines for values and ethics in higher education. The guidelines are being launched at a time when the student involvement in political issues has come under scrutiny.

Significance

The documents will help improve the quality of institutions of higher education in the country. The implementation of evaluation reforms in higher educational institutions will help achieve high learning outcomes. The documents are released to support administration in making right and timely decision.

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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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