Lok Sabha Question No. 4802 (UNSTARRED), answered on 2025-03-28
Subject: Misleading Advertisements for AYUSH Drugs
Ministry: AYUSH
Asked by: Shri Sukhdeo Bhagat

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 4802 TO BE ANSWERED ON 28 th  MARCH 2025

'Misleading Advertisements for AYUSH Drugs'

## 4802. Shri Sukhdeo Bhagat:

## Will the Minister of AYUSH be pleased to state:

(a) whether the Government has any efforts to curb misleading advertisements as there has been a significant increase in such cases during the last three years and if so, the details thereof;

(b)  whether it  is  a  fact  that  the  Supreme  Court  temporarily  stayed  a  Ministry  notification  that contradicted earlier directives against misleading ads and if so, the details thereof;

(c) whether in view of this upward trend and legal challenges any concrete measures have been implemented  by  the  Government  to  effectively address and  reduce the proliferation of misleading AYUSH drug advertisements; and

(d) if so, the details thereof along with the steps taken thereon?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV)

(a),  (c)  &  (d)  Yes  sir,  Ministry  of  Ayush  implemented  a  Pharmacovigilance  Program  for Ayurveda,  Siddha,  Unani  and  Homoeopathy  (ASU&H)  drugs  as  a  component  of  Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY) scheme under its Central Sector  Scheme.  The  pharmacovigilance  program  is  working  through  a  three-tier  network  of  a National  Pharmacovigilance  Centre  (NPvCC),  Five  Intermediary  Pharmacovigilance  Centre's (IPvCs) and 99 Peripheral Pharmacovigilance Centres (PPvCs) established across the country.

These  centres  are  mandated  to  monitor  and  report  the  misleading  advertisements  to  the respective State Regulatory Authorities for suitable action against the defaulter.

In the last three years, misleading advertisements related to Ayush drugs have been reported to the respective state licensing authorities for appropriate action against the defaulters, as attached in Annexure I.

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.

Further,  Ministry  of  Ayush  issued  an  advisory  dated  18.04.2024  and  directed  to  all  State/UT Ayush Drug Licensing Authorities, all Ayush drug manufacturers/associations, and the National Pharmacovigilance Coordination Centre regarding 'Compliance to the labelling provisions for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs/medicines'.

Additionally,  Ministry  of  Ayush  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.

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.

(b) Ministry of Ayush vide Gazette notification no.- G.S.R. 360(E) dated 01.07.2024 has 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.

Annexure-I The details of misleading advertisements related to Ayush medicines noticed by pharmacovigilance and reported to SLA are as follows:

| S. No.   | Duration                    | Misleading Advertisements   |
|----------|-----------------------------|-----------------------------|
| 1        | March, 2022- February, 2023 | 7,417                       |
| 2        | March, 2023- February, 2024 | 7,790                       |
| 3        | March, 2024- February, 2025 | 11,119                      |
| Total    | Total                       | 26,326                      |

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