Drugs (First Amendment) Rules, 2025

Act Name/Rule Name: Drugs and Cosmetics Act, 1940
Type of Document: Notification
Date: January 10, 2025
Circular No./Notification No.: G.S.R. 28(E)

The draft amendment to the Drugs Rules, 1945 was published for public feedback in December 2023. After considering the objections and suggestions, the Central Government, in consultation with the Ayurveda, Siddha, and Unani Drugs Technical Advisory Board, has finalized the amendments.

Description: The amendment introduces the following changes:

  1. Licensing Requirement for Nasal Sprays: A new sub-rule (VI) is inserted under Rule 158B (that deals with “Guidelines for issue of license with respect to Ayurveda, Siddha or Unani drags”) of the Drugs Rules, 1945. It mandates that Licensing Authorities shall follow the guidelines provided in Schedule TB for issuing licenses for Ayurveda, Siddha, and Unani drugs in nasal spray form.
  2. Introduction of Schedule TB: A new Schedule TB is added, detailing the guidelines for developing nasal sprays as a dosage form for Ayurveda, Siddha, and Unani drugs.

This amendment aims to regulate the production of nasal sprays in the traditional medicine systems of Ayurveda, Siddha, and Unani, ensuring their development follows standardized guidelines for safety and efficacy. The rules ensure better regulation and promote innovation in the field of traditional medicines while maintaining public health standards.

 

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