National Regulatory Authority of India meets WHO international standards for vaccine regulations

National Regulatory Authority of India meets WHO internationalstandards for vaccine regulations

Question: WHO international standards for vaccine regulations include-
1. Quality 2. Safety 3. Efficacy

(a) (1) and (3)
(b) (2) and (3)
(c) (1) and (3)
(d) All (1),(2) and (3)
Ans: (d)
Related facts:

  • On 17 February 2017; the National Regulatory Authority of India (NRA) and affiliated institutions meet the WHO Global Benchmarking Tool requirements for a functional vaccine regulatory system.
  • A World Health Organization (WHO) led team of international experts from several countries came to this conclusion at the end of a comprehensive review from 13-17 February 2017.
  • Affiliated institutions includes, Central Drugs Standards Control Organization (CDSCO); Central Drugs Laboratory, Kasauli; Pharmaco-vigilance Programme and Immunization Division, and other relevant institutions engaged in the regulation, control and testing of vaccines.
  • One of the requirements to become eligible and retain the prequalification status is to have the NRA assessed as functional against the WHO Global Benchmarking Tool.
  • Safety, efficacy and quality are three basic parameters of assessment of vaccines.

Reference:
http://pib.nic.in/newsite/PrintRelease.aspx?relid=158598
http://www.searo.who.int/india/mediacentre/releases/who_india_nrapress_release_20170217.pdf