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Source- This post on Rule 170 of the Drugs and Cosmetics Act has been created based on the article “Supreme Court Stays Ayush Ministry’s Notification That Omitted Prohibition On Ads Of Ayurvedic, Unani & Siddha Drugs Without Approval” published in “PIB” on 31st August 2024.
Why in News?
The Supreme Court has recently put a hold on a Central government notification that aimed to remove Rule 170 from the Drugs and Cosmetics Rules of 1945.
About Rule 170 of the Drugs and Cosmetics Act
1. It was introduced in 2018 as part of the Drugs and Cosmetics Act.
2. Purpose: Its primary purpose is to regulate and prevent misleading advertisements of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy) products.
3. Key Provisions of Rule 170: The rule prohibits advertisements without proper approval. Advertisements can be rejected if:
i) The manufacturer does not provide contact details.
ii) The content is deemed obscene or vulgar.
iii) It includes claims about enhancing sexual organs.
iv) It features celebrities or government officials, references any government organization, or makes false, misleading, or exaggerated claims.
4. Requirements Under Rule 170: AYUSH product manufacturers must obtain approval and a unique identification number from the state licensing authority before advertising their products.
5. Manufacturers are required to provide detailed information, including textual references, rationale for the medicine based on authoritative books, intended use, and evidence of safety, effectiveness, and quality.
Challenges in Regulating AYUSH Drugs
1. Licensing Requirements: Like allopathic (modern) medicines, AYUSH drugs also require a license from the drug controller.
2. Clinical Trials: Unlike allopathic drugs, AYUSH products generally do not require phase I, II, or III trials for approval. Most AYUSH drugs are approved based on the rationale provided in authoritative texts from their respective disciplines.
3. Safety Trials: Safety trials are mandatory only for formulations that use about 60 specific ingredients listed in the act, such as snake venom, heavy metals (e.g., arsenic, mercury), and compounds like copper sulfate.
4. Proof of Effectiveness: For licensing drugs containing these ingredients or traditional drugs used for new indications, proof of effectiveness must be provided as per the Act.
Why did the AYUSH Ministry Recommend Ignoring Rule 170?
1. The Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB) which is an expert body for regulating AYUSH drugs, suggested in a May 2023 meeting that Rule 170 could be omitted.
2. This suggestion was made because amendments to the Drugs and Magic Remedies Act, another law aimed at preventing misleading advertisements, were also being considered by the health and AYUSH ministries.
3. In light of ASUDTAB’s recommendation and ongoing legislative changes, the AYUSH Ministry advised state licensing authorities to disregard Rule 170.
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