Executive Summary:
This document addresses concerns regarding misleading advertisements of AYUSH (Ayurveda, Siddha, Unani, and Homoeopathy) products. It outlines steps taken by the Indian government to ensure consumer protection and prevent unverified claims by AYUSH product manufacturers. The Supreme Court has stayed the omission of Rule 170 of the Drugs Rules, 1945, related to misleading advertisements, until further notice (dated 27.08.2024). The Ministry of Ayush launched the Ayush Suraksha portal on 30th May 2025 to track misleading advertisements and adverse drug reactions.
Key Points / Main Content:
Rule 170 Status:
* The Ministry of Ayush omitted Rule 170 of the Drugs Rules, 1945, via notification G.S.R. 360E dated 01.07.2024, based on recommendations from ASUDTAB.
* The Supreme Court stayed the notification omitting Rule 170 on 27.08.2024; Rule 170 remains sub judice.
Consumer Protection Measures:
* Pharmacovigilance Program: The Pharmacovigilance Program for ASU&H Drugs, under the AOGUSY scheme, uses a three-tier network (NPvCC, IPvCs, PPvCs) to monitor and report misleading advertisements to State Regulatory Authorities.
* Drugs and Magic Remedies Act: The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and its rules prohibit misleading advertisements for drugs, including AYUSH medicines. The Ministry of Ayush directs SLAs to enforce this Act.
* Public Notice: The Ministry of Ayush issued a public notice on 08.10.2024, published in 100 newspapers, to warn the public about misleading advertisements of ASUH drugs/medicines.
* GAMA Portal: The Department of Consumer Affairs' GAMA portal addresses misleading advertisements. TV advertisement complaints are forwarded to the Ministry of Information and Broadcasting.
* Ayush Suraksha Portal: An IT-enabled online portal launched on 30th May 2025 for healthcare professionals and the public to track misleading advertisements/objectionable advertisements and adverse drug reactions.
Impact Analysis:
AYUSH Product Manufacturers:
Impact: Subject to increased scrutiny regarding advertising claims and potential regulatory action for misleading advertisements.
Action Required: Ensure all advertising and promotional materials comply with the Drugs and Magic Remedies Act, 1954, and refrain from making unverified claims.
Consumers:
Impact: Better protected from misleading advertisements related to AYUSH products through increased monitoring and reporting mechanisms.
Action Required: Utilize the Ayush Suraksha portal and GAMA portal to report misleading advertisements and be aware of the public notice issued by the Ministry of Ayush.
State Licensing Authorities (SLAs):
Impact: Responsible for enforcing the Drugs and Magic Remedies Act, 1954, and taking action against misleading advertisements of AYUSH products.
Action Required: Enforce regulations against misleading advertisements based on reports from the Pharmacovigilance Program and other sources.
AYUSH Healthcare Professionals:
Impact: Can contribute to monitoring and reporting misleading advertisements and adverse drug reactions.
Action Required: Utilize the Ayush Suraksha portal to report misleading advertisements and adverse drug reactions.
Key Entities Referenced
Ministry of Ayush: The Indian government ministry responsible for the development and promotion of AYUSH systems of medicine.
Shri K C Venugopal: Member of Parliament who raised the question about misleading advertisements of AYUSH products.
Rule 170 of the Drugs Rules, 1945: A rule within the Drugs Rules, 1945, that aimed to prevent misleading advertisements of AYUSH products. Its omission was stayed by the Supreme Court.
Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB): A board that made recommendations to the Ministry of Ayush, leading to the initial omission of Rule 170.
Supreme Court of India: The highest judicial body in India, which stayed the notification regarding the omission of Rule 170 of the Drugs Rules, 1945.
Pharmacovigilance Program for Ayurvedic, Siddha, Unani and Homoeopathy (ASU H Drugs): A program implemented under the Central Sector Scheme Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY) to monitor and report misleading advertisements of AYUSH drugs.
Drugs and Magic Remedies Objectionable Advertisements Act, 1954: An Indian law that prohibits misleading advertisements and exaggerated claims of drugs and medicinal substances, including AYUSH medicines.
Ayush Suraksha: An IT enabled online portal developed and launched by the Ministry of Ayush for Ayush Health care professionals and general public to track the reported misleading advertisements (MLAs)Objectionable Advertisements (OAs) and Adverse Drug Reactions (ADRs).
GOVERNMENT OF INDIA
MINISTRY OF AYUSH
LOK SABHA
UNSTARRED QUESTION NO. 993
TO BE ANSWERED ON 25th July, 2025
“Misleading Advertisements of AYUSH Products”
993. Shri K C Venugopal:
Will the Minister of Ayush be pleased to state:
(a) whether the Government is aware of the various concerns raised due to the directive to State
licensing authorities to disregard Rule 170 of the Drugs and Cosmetics Act, which aims to prevent
misleading advertisements of AYUSH products and if so, the details thereof.
(b) whether steps taken by the Government to ensure consumer protection and prevent the
dissemination of unverified claims by AYUSH product manufacturers and if so, the details thereof;
(c) whether there are plans to revise or strengthen guidelines under Rule 170 in response to these
concerns; and
(d) if so, the details thereof along with the timeline for implementing such revisions?
ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH
(SHRI PRATAPRAO JADHAV)
(a) , (c) and (d) Ministry of Ayush vide Gazette notification no.- G.S.R. 360(E) dated
01.07.2024 omitted Rule 170 of the Drugs Rules, 1945 based on recommendations from
the Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB). Further,
Hon’ble Supreme Court of India vide its order dated 27.08.2024 in W.P. (CIVIL)
NO.645/2022 has stayed the notification of omission of Rule 170 of the Drugs Rules, 1945
till further orders. The Rule 170 of the Drugs Rules, 1945 is subjudice.
(b) The steps taken by the Government to ensure consumer protection and prevent the
dissemination of unverified claims by Ayush product manufacturers are as follows: -
1. The Pharmacovigilance Program for Ayurvedic, Siddha, Unani and Homoeopathy
(ASU & H) Drugs has been implemented under Central Sector Scheme Ayush
Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY), which work
1through a three-tier network of a National Pharmacovigilance Centre (NPvCC),
Five Intermediary Pharmacovigilance Centers (IPvCs) and 97 Peripheral
Pharmacovigilance Centers (PPvCs) established across the country. These centres
are mandated to monitor and report misleading advertisements to the respective
State Regulatory Authorities for suitable action against the defaulter. Objectives of
this program is to keep vigilance over Ayush drugs and to reduce misleading
advertisements to ensure the consumer protection and prevent the dissemination of
unverified claims by Ayush product manufacturers.
2. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules
thereunder encompass the provisions for prohibition of misleading advertisements
and exaggerated claims of drugs and medicinal substances including Ayush
medicines, which appear in the print and electronic media and Ministry of Ayush
has issued advisories and gives direction to SLAs to enforce and regulate as per the
provision of this Act.
3. Ministry of Ayush has issued a public notice on 08.10.2024, informing the general
public about the facts regarding ASU&H drugs/medicines and urging them to avoid
patronizing misleading advertisements, which was published in 100 leading
newspapers across India in Hindi, English, and several regional languages.
4. The Department of Consumer Affairs (DoCA) maintains the Grievances Against
Misleading Advertisements (GAMA) portal, providing a platform to address
instances of misleading advertisements. Further, as the regulations and enforcement
for TV Channels falls under the mandate of Ministry of Information and
Broadcasting (MoIB), therefore references of misleading advertisement getting
broadcasted on TV channels are forwarded to MoIB for action.
5. Ministry of Ayush has developed and launched an IT enabled online portal “Ayush
Suraksha” for Ayush Health care professionals and general public to track the
reported misleading advertisements (MLAs)/Objectionable Advertisements (OAs)
and Adverse Drug Reactions (ADRs) on 30th May 2025.
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