10th January 2025, G.S.R. 28(E)

Here’s a simplified, pointwise breakdown of the key aspects of the amendment to the Drugs Rules, 1945, published in the Gazette:

Amendment Title and Commencement:

Name: The rules are called the Drugs (First Amendment) Rules, 2025.
Effective Date: The rules come into effect on the day they are published in the Official Gazette (i.e., January 10, 2025).

Key Addition: Rule 158 B Amendment

• New Sub-rule: A new sub-rule (VI) is added to Rule 158 B of the Drugs Rules, 1945.
• Licensing Requirement: This sub-rule states that for issuing licenses for Ayurvedic, Siddha, and Unani medicines in “nasal spray” form, the Licensing Authorities must follow the guidelines provided in a new “Schedule TB.”

Schedule TB: Guidelines for Nasal Spray Development

Purpose: Schedule TB provides guidelines for the development of nasal spray dosage forms specifically for Ayurveda, Siddha, and Unani (ASU) drugs.

I. Introduction: (Background on Nasya, the traditional practice)

• Explains the concept of “Nasya” (nasal administration) in Ayurveda.
  Describes different types of Nasya and their uses for various ailments, primarily related to head and neck conditions. Mentions examples of classical formulations used.
  Mentions about use of Nasya in Siddha and Unani system.

II. Definition: (Nasal Spray)

• Defines a nasal spray as a liquid or powder formulation dispensed as a fine spray into the nostril using a device.
• Highlights the difference between traditional Nasya (using medicated oils/juices without a device) and the new nasal spray (using a device).
• Clarifies that the amendment does not interfere with existing Nasya methods.

III. Differentiation from Nasya

• Explains that the nasal spray is administered with a specific device.
  The existing nasya methods shall continue and medications standards for those items remain the same as per the Ayurvedic Pharmacopoeia of India (API).
• The Standard Operating Procedures (SOPs) for the performance of Nasya shall also be the same as those developed by Central Council for Research in Ayurvedic Sciences (C.C.R.A.S.).

IV. Guidelines for Active Ingredient Selection: Active ingredients should be selected according to the definition of Ayurvedic, Siddha, or Unani drugs under the Drugs and Cosmetics Act, 1940.

V. Guidelines for Excipient Selection: Excipients must be selected according to Rule 169 of the Drugs Rules, 1945, and its amendments.

VI. Specifications for the Device: Provides guidance for the selection of packaging material and parameters to be considered.

VII. Specifications for the Finished Product (mandatory): This section likely outlines the essential quality standards that the final nasal spray product must meet.

VIII. Specifications for the Finished Product (optional): This section may provide additional, non-mandatory quality specifications that manufacturers can choose to include.

IX. One-time studies as part of product development (mandatory): These studies (e.g., on multiple batches) are required and are to be submitted with the license application.

X. Stability Guidelines: Stability studies should follow the guidelines provided in the relevant pharmacopoeia (e.g., Ayurvedic Pharmacopoeia of India).

XI. Safety and Efficacy Studies: Safety and efficacy studies need to be conducted as per Rule 158 B of the Drugs Rules, 1945 and amendments, as well as specific guidelines (e.g., for toxicity, mucosal irritation, and clinical trials following GCP guidelines).

Note: Refers to the original Drugs Rules and previous amendments.

Key Takeaways for Implementation:

• Licensing Authorities: Must use Schedule TB guidelines when issuing licenses for ASU nasal sprays.
• Manufacturers:
  • Must adhere to the guidelines in Schedule TB for developing nasal spray formulations.
  • This includes selecting appropriate active ingredients, excipients, device specifications, and conducting necessary studies (stability, safety, efficacy).
  • Need to understand the differentiation from traditional nasya methods and the continued guidelines.
• Practitioners: Should stay informed about the availability and regulatory status of ASU nasal spray products.
• Focus: The amendment emphasizes the safety and efficacy of ASU nasal sprays and the need for regulatory oversight of this dosage form.

Disclosure

Important Notice: Simplified Version of Regulation Updates

This simplified version of the recent regulation updates is provided solely for general understanding and informational purposes. It may not contain all the specific details or true information as presented in the original e-gazette.

For comprehensive and accurate information, we strongly recommend visiting the original gazette document. Additionally, before implementing any changes or actions based on these updates, please consult with qualified experts to ensure compliance and proper understanding of the regulations.

The information contained herein is not a substitute for professional advice.