4th December 2024, S.O. 5285 (E) - E-Gazette Simplified
Here are the important points from the Ministry of AYUSH notification regarding amendments to the Drugs and Cosmetics Act, 1940, presented in a simplified and pointwise format for easier implementation:
Context and Purpose of Notification:
The amendments were made to the Drugs and Cosmetics Act, 1940, based on public feedback received after a draft was circulated in January 2024. The amendments aim to include additional systems of medicine.
Addition of Homoeopathic and Sowa-Rigpa Systems:
- A new section titled “C. —HOMOEOPATHIC SYSTEM” has been added to the **First Schedule** of the Act. This section will contain a list of relevant books related to Homoeopathy.
- Additionally, “D. SOWA-RIGPA SYSTEM” has also been introduced in the First Schedule, which will include a list of the associated texts.
Updates in the Second Schedule:
- In the **Second Schedule**, specifically in item number 4A:
- Under sub-item (b), after mentioning “the German Homoeopathic Pharmacopoeia,” the text will also include “or the French Homoeopathic Pharmacopoeia or the European Pharmacopeia.”
- Similarly, under sub-item (c), it will be updated to state “the German Homoeopathic Pharmacopoeia or the French Homoeopathic Pharmacopoeia or the European Pharmacopeia.”
Implications for Stakeholders:
- Pharmacists, manufacturers, and practitioners in the fields of Homoeopathy and Sowa-Rigpa should familiarize themselves with the newly included books and references.
- Compliance with the updated standards and guidelines in these schedules will be essential for regulatory adherence.
Consultation and Implementation:
- The amendments were made after consultations with the Ayurveda, Siddha, and Unani Drugs Technical Advisory Board, indicating a collaborative decision-making process.
- Stakeholders should keep themselves updated on any further guidelines that may be issued following these amendments.
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.