The World Health Organisation (WHO) announced that that the National Regulatory Authority of India (NRAI) meets the WHO’s Global Benchmarking Tool (GBT) requirements for vaccines.
The announcement was made by the United Nations (UN) agency at the end of a comprehensive review, which was held between 13 February and 17 February 2017.
Details related to the announcement
• The WHO gave maximum ratings to the NRAI for vaccine regulations after assessing the maturity of the Indian vaccine production ecosystem.
• The assessment has been done in respect of 14 different functions. Out of them, 9 functions have met the ‘Level 4’ standards, while remaining 5 functions have met the ‘Level 3’ standards.
• Maturity level 4 indicates good results and sustained improvement trends. While, the level 3 reflects systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends.
What is the significance of the assessment?
• Next to the information technology services exports, pharmaceutical products constitute one of India’s major export items.
• As per an estimate, Indian pharmaceutical companies exported USD 25 billion worth of products in FY 2014-15.
• Moreover, India is one of the major suppliers of vaccines to the United Nations agencies, especially the WHO and the United Nations International Children's Fund (UNICEF).
• Against this backdrop, it is in India’s interest to get assessed its vaccine regulation programme by the WHO.
• WHO Prequalification Programme facilitates access to vaccines that meet the unified standards of quality, safety and efficacy as well as programme needs.
What is the WHO Prequalification Programme?
• Any manufacturer of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) can express an interest in having its API or FPP products evaluated by the WHO.
• The manufacturer of each pre-qualified APIs is issued with a document known as a WHO Confirmation of Active Pharmaceutical Ingredient Prequalification.
• This document contains the accepted active ingredient specifications and copies of the assay and related substances test methodology.
• Similarly, FPPs that are considered to have met pre-qualification requirements are included in the WHO List of Prequalified Medicinal Products.
When: February 2017