Current Status of Rule 170 in Drugs and Cosmetics Act and Rules, 1940 and 1945
Journal name: Ayushdhara
Original article title: Current Status of Rule 170 in Drugs and Cosmetics Act & Rules, 1940 & 1945
AYUSHDHARA is an international peer-reviewed journal. It focuses on research in Ayurveda, Yoga, Unani, Siddha, Homeopathy, Allopathy, and Pharmaceutical Sciences.
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Sudhanya V. S
PG Scholar, Dept of Rasa Shastra and Bhaishajya Kalpana, Govt. Ayurvedic College, Patna, Bihar, India.
Prabhat Kumar Dwivedi
Professor, Dept of Rasa Shastra and Bhaishajya Kalpana, Govt. Ayurvedic College, Patna, Bihar, India.
Ayushdhara:
(A peer-reviewed, bi-monthly open-access journal)
Full text available for: Current Status of Rule 170 in Drugs and Cosmetics Act & Rules, 1940 & 1945
Year: 2024 | Doi: 10.47070/ayushdhara.v11i3.1599
Copyright (license): CC BY-NC-SA 4.0
Summary of article contents:
Introduction
The Drugs and Cosmetics Act of 1940, along with its associated Rules from 1945, was established to regulate the import, manufacture, distribution, and sale of various drugs and cosmetics, including Ayurveda, Siddha, and Unani medicines. Among the comprehensive provisions laid out in this framework is Rule 170, which specifically prohibits misleading advertisements pertaining to these traditional medicinal products. Recently, Rule 170 has come under scrutiny due to proposed amendments that have generated public confusion regarding its current status, particularly following a notification from the Ministry of AYUSH indicating its possible omission.
Status of Rule 170 and Its Implications
Rule 170, introduced in 2018, aimed to ensure the accuracy and safety of advertisements related to Ayurveda, Siddha, and Unani drugs by requiring manufacturers to obtain a Unique Identification Number before engaging in advertising. However, the rule's effectiveness has been called into question, especially after the Ministry of AYUSH issued a directive in August 2023, instructing licensing authorities not to enforce the rule while a final decision on its omission was awaited. This action was fueled by concerns raised during the Patanjali case involving misleading health claims that undermined allopathic medicine. As of July 2024, the Ministry of AYUSH has formally proposed the total omission of Rule 170, leading to increasing public uncertainty regarding the enforcement of regulation surrounding misleading advertisements of these traditional drugs.
Legal and Regulatory Developments
The ongoing legal discourse surrounding Rule 170 has involved various stakeholders—including manufacturers, health authorities, and the judiciary—reflecting broader concerns about the integrity of health communications. Despite suggestions from the Ayurvedic, Siddha, and Unani Drug Technical Advisory Board (ASUDTAB) that the rule should not be omitted, the Ministry’s ongoing consultations and recent proposals for amendments indicate an evolving regulatory landscape. The outcome of public objections and the lack of definitive court rulings related to Rule 170 further complicate its current status, as various High Courts have heard petitions challenging the rule’s legitimacy without issuing concrete decisions.
Conclusion
The recent developments regarding Rule 170 highlight significant ambiguities in the regulation of advertisements for Ayurveda, Siddha, and Unani drugs. While the Ministry of AYUSH has indicated plans to formally omit the rule, as reflected in notifications from early July 2024, the timeline for this change remains unclear. The ongoing deliberations and public feedback suggest that the framework governing the promotion of these traditional medicines continues to evolve, reflecting the need for regulatory clarity to protect consumers from misleading health claims and to ensure that safety standards persist in the landscape of Indian healthcare.
FAQ section (important questions/answers):
What is Rule 170 in the Drugs and Cosmetics Act?
Rule 170 pertains to the prohibition of misleading advertisements for Ayurveda, Siddha, or Unani drugs, ensuring that all advertisements are authorized by the relevant licensing authorities to prevent false health claims.
What recent changes have occurred regarding Rule 170?
On August 29, 2023, the Ministry of AYUSH directed authorities not to act under Rule 170, causing confusion. Subsequent amendments indicate that Rule 170 is to be omitted, with a formal notification pending.
How does the public influence the fate of Rule 170?
Public objections and suggestions are considered by the Central Government regarding proposed changes to Rule 170, culminating in notifications about its potential omission in The Indian Gazette, reflecting ongoing discussions and concerns.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Current Status of Rule 170 in Drugs and Cosmetics Act and Rules, 1940 and 1945�. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
A drug pertains to Ayurveda, Siddha, Unani, Allopathic, Homeopathic, and other systems of medicine, and their regulation is a primary focus of the Drugs and Cosmetics Act, 1940. The central and state governments are involved in the import, manufacture, and administration of drugs under this legislation.
2) Siddha:
Siddha, along with Ayurveda and Unani, is one of the traditional systems of medicine regulated under the Drugs and Cosmetics Act, 1940. Rule 170 specifically addresses misleading advertisements related to Siddha drugs to ensure they meet certain standards before being promoted.
3) Ayus (Ayush):
The Ministry of AYUSH in India oversees traditional systems of medicine, including Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy. It issued notifications regarding the omission of Rule 170 in the Drugs and Cosmetics Rules, 1945.
4) India:
India is the nation where the Drugs and Cosmetics Act, 1940, was enacted to regulate the import, manufacture, sale, and distribution of drugs and cosmetics, including Ayurveda, Siddha, and Unani systems of medicine. The legislation ensures the safety and efficacy of these products.
5) Ayurveda (Ayus-veda):
Ayurveda is a traditional system of medicine in India that, along with Siddha and Unani, falls under the regulatory purview of the Drugs and Cosmetics Act, 1940. Rule 170 aims to prevent misleading advertisements about Ayurveda drugs, ensuring that claims made about these products are accurate and truthful.
6) Indian:
The term 'Indian' is relevant in the context of the Indian Medical Gazette and Indian Medical Association. The Drugs and Cosmetics Act of 1940 came into being in response to concerns raised by Indian organizations about the quality of healthcare and drugs provided under British rule.
7) Medicine:
Medicine in the context of the Drugs and Cosmetics Act, 1940, includes various systems like Ayurveda, Siddha, Unani, and Allopathic. The act ensures the regulation of these medicines' import, manufacture, distribution, and sale, and Rule 170 specifically deals with the advertisement of traditional medicines to prevent misleading claims.
8) Delhi:
[see source text or glossary: Delhi]
9) Blood:
The Drugs and Cosmetics Rules include provisions for the collection, storage, processing, and distribution of whole human blood and its components by blood banks in India, ensuring that blood products meet statutory quality standards.
10) New Delhi:
New Delhi is where the Drugs and Cosmetics Rules, 1945, including Rule 170, came into existence via notification from the Department of Health, Government of India. It is a central administrative hub for such regulations.
11) Family:
The term 'Family' relates to the Ministry of Health and Family Welfare in India, which is involved in the regulatory framework of drugs and cosmetics, ensuring public safety and efficacy of these products under the Drugs and Cosmetics Act, 1940.
12) Kumar:
Kumar refers to Prabhat Kumar Dwivedi, one of the authors of the article discussing the status of Rule 170 in the Drugs and Cosmetics Act and Rules. He is a professor in the Department of Rasa Shastra and Bhaishajya Kalpana at the Government Ayurvedic College in Patna.
13) Patanjali:
Patanjali is a notable Ayurvedic product manufacturer that has been involved in legal cases concerning misleading advertisements. The controversy around Patanjali's advertisements was a significant factor in the discussions about Rule 170 in the Drugs and Cosmetics Rules.
14) Disease:
The term 'Disease' is relevant to Rule 170, which pertains to the prohibition of misleading advertisements of Ayurveda, Siddha, or Unani drugs for diagnosing, curing, mitigating, treating, or preventing any diseases.
15) Rasashastra (Rasa-shastra, Rasasastra):
Rasa-shastra is a branch of Ayurveda that deals with pharmaceutical theories and practices using metals and minerals. Sudhanya V. S and Prabhat Kumar Dwivedi, affiliated with this department at the Government Ayurvedic College, explore the current status of Rule 170.
16) Bhaishajya (Bhaisajya):
[see source text or glossary: Bhaishajya]
17) Discussion:
The discussion in the article centers on the current status and controversies regarding Rule 170, which deals with preventing misleading advertisements of Ayurveda, Siddha, or Unani drugs under the Drugs and Cosmetics Rules, 1945.
18) Shastra (Sastra):
[see source text or glossary: Shastra]
19) Kalpana:
[see source text or glossary: Kalpana]
20) Citizen:
Citizens of India benefit from the Drugs and Cosmetics Act, 1940, which aims to regulate and ensure the quality of drugs and cosmetics available in the country, thereby safeguarding public health.
21) Patna:
Patna is the location of the Government Ayurvedic College, where authors Sudhanya V. S and Prabhat Kumar Dwivedi are based. They have written about the current status of Rule 170 in the Drugs and Cosmetics Act.
22) Bihar:
Bihar is the Indian state where the Government Ayurvedic College is located, and it is also where the study on the status of Rule 170 in the Drugs and Cosmetics Act was conducted by Sudhanya V. S and Prabhat Kumar Dwivedi.
23) Rupee:
The term 'Rupee' refers to the application fee mentioned in Rule 170, which mandates a fee of one thousand rupees per advertisement of Ayurveda, Siddha, or Unani drugs to be submitted for approval by the state licensing authority.
24) Rasa (Rasha):
[see source text or glossary: Rasa]
Other Science Concepts:
Discover the significance of concepts within the article: �Current Status of Rule 170 in Drugs and Cosmetics Act and Rules, 1940 and 1945�. Further sources in the context of Science might help you critically compare this page with similair documents:
Central government, Clinical trial, Ministry of AYUSH, Drugs and Cosmetics Act, Drugs and Cosmetic Rules, Misleading advertisement, Unique Identification Number, Drugs and Cosmetic Act, 1940.
Concepts being referred in other categories, contexts and sources.