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3 July 2026

Amendment to Drugs Rules 1945

This amendment represents a significant regulatory update to the Drugs Rules, 1945, directly impacting the governance of emerging medical technologies and falling under the purview of statutory regulatory frameworks.

1 min read Day 1 of 2 1 questions 1 prelims

Notes

  • The Central government has amended the Drugs Rules, 1945 to enhance regulatory oversight of advanced and emerging medical technologies.
  • The amendment brings stem cell-derived products, gene therapeutic products, and xenografts under the purview of the Centrally License Approving Authority (CLAA) framework.
  • The CLAA framework previously covered vaccines, large volume parenterals, and r-DNA based medicines.
  • The objective of the amendment is to ensure uniform regulations across the country for these advanced medical products.

Part of a longer story

This is day 1 of 2 in Amendments to the Drugs Rules 1945, which has been running since 3 July 2026. Reading it whole is usually worth more than reading today alone — the exam asks how something developed.

Questions

  1. Discuss the significance of bringing emerging medical technologies like gene therapy and stem cell-derived products under the Centrally License Approving Authority (CLAA) framework in the context of public health safety. 150 words
    Attempt this — 150 words in 8 min
    0 / 150 words 8:00

Prelims

  1. Which of the following categories of medical products have been recently brought under the ambit of the Centrally License Approving Authority (CLAA) framework by the amendment to the Drugs Rules, 1945?

Syllabus

Topics

Sources

250words.in · https://250words.in/daily/2026-07-03/amendment-to-drugs-rules-1945