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27 June 2026

Simplification of drug import rules

The proposed amendments to the Drugs Rules, 1945 represent a specific regulatory intervention aimed at improving ease of doing business and supporting pharmaceutical R&D, which is a relevant topic for governance and industrial policy.

2 min read 2 questions 2 prelims

Notes

  • Union Health Ministry proposed amendments to the Drugs Rules, 1945 to simplify import procedures for drugs intended for examination, test, or analysis.
  • Introduction of an acknowledgement-based system for small quantity imports, replacing the previous licensing requirement.
  • Applicants must submit a prior intimation form to receive an acknowledgement, which serves as the basis for import.
  • Exclusions from the new system: sex hormones, cytotoxic drugs, beta lactam drugs, biologics with live microorganisms, and narcotic/psychotropic substances.
  • The policy aims to reduce compliance burden and support R&D and start-ups in the pharmaceutical sector.
  • Proposed amendment to Rule 31 of the Drugs Rules, 1945 seeks to change the residual shelf-life norm for imported drugs from >60% to a minimum of 12 months.
  • Biological products and radio pharmaceuticals are excluded from the 12-month shelf-life rule and will continue to follow the >60% residual shelf-life requirement.
  • The shelf-life change aims to improve pharmaceutical supply chain efficiency while ensuring drug quality for patients.

Questions

  1. Discuss how the proposed amendments to the Drugs Rules, 1945, aim to promote ease of doing business and foster research and development in the Indian pharmaceutical sector. 150 words
    Attempt this — 150 words in 8 min
    0 / 150 words 8:00
  2. The simplification of drug import regulations is a critical step in balancing regulatory oversight with the need for pharmaceutical innovation. Critically examine the implications of these changes for public health and the domestic R&D ecosystem. 250 words
    Attempt this — 250 words in 11 min
    0 / 250 words 11:00

Prelims

  1. Under the proposed amendments to the Drugs Rules, 1945, which of the following categories of drugs is NOT eligible for the new acknowledgement-based import system for testing purposes?

  2. What is the proposed change to the residual shelf-life norm for general imported drugs under the draft amendment to Rule 31 of the Drugs Rules, 1945?

Syllabus

Topics

Sources

250words.in · https://250words.in/daily/2026-06-27/simplification-of-drug-import-rules