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Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

India’s Drug Standards Gain Global Recognition

Why in the News?

India has risen from 123rd to 8th position globally in contributions to the World Health Organization’s pharmacovigilance database, as stated by Union Health Minister J. P. Nadda during the release of Indian Pharmacopoeia 2026.

Key Announcement

  • India ranked 8th globally in WHO pharmacovigilance contributions in 2025
  • Earlier rank was 123rd during 2009 to 2014
  • Announcement made at the release of Indian Pharmacopoeia 2026
  • Event held at Dr Ambedkar International Centre, New Delhi

About Indian Pharmacopoeia

  • Official book of drug standards for India
  • Published by Indian Pharmacopoeia Commission
  • 2026 edition is the 10th edition
  • Sets standards for quality, purity and strength of medicines

Key Features of Indian Pharmacopoeia 2026

  • 121 new monographs added
  • Total monographs increased to 3,340
  • Expanded coverage of
    • Anti tubercular medicines
    • Anti diabetic medicines
    • Anti cancer medicines
    • Iron supplements
  • Supports standardisation under National Health Programmes

Pharmacovigilance Programme of India

  • Known as Pharmacovigilance Programme of India
  • Implemented under the Indian Pharmacopoeia Commission
  • Monitors adverse drug reactions and medicine safety
  • Major contributor to WHO global drug safety database

International Significance

  • Indian Pharmacopoeia standards now recognised in 19 countries of the Global South
  • Pharmacopoeia standards form part of India’s health diplomacy
  • Reflects India’s leadership in pharmaceutical regulation and manufacturing

Regulatory Advancement

  • First time inclusion of 20 blood component monographs
  • Related to transfusion medicine
  • In line with Drugs and Cosmetics Second Amendment Rules 2020

Prelims Pointers

  • WHO maintains a global pharmacovigilance database
  • Indian Pharmacopoeia is a statutory reference for drug quality
  • Pharmacovigilance focuses on drug safety after market approval
  • Blood component monographs are linked to transfusion safety
[2019] Which of the following are the reasons for the occurrence of multi-drug resistance in microbial pathogens in India? 

1. Genetic predisposition of some people 

2. Taking incorrect doses of antibiotics to cure diseases 

3. Using antibiotics in livestock farming 

4. Multiple chronic diseases in some people 

Select the correct answer using the code given below: 

(a) 1 and 2 (b) 2 and 3 only (c) 1, 3 and 4 (d) 2, 3 and 4

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