Lok Sabha Question No. 3076 (UNSTARRED), answered on 2024-08-09
Subject: Misleading AYUSH Advertisements
Ministry: AYUSH
Asked by: Shri Kota Srinivasa Poojary

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 3076 TO BE ANSWERED ON 09 th  August 2024

'Misleading AYUSH Advertisements'

## 3076. Shri Kota Srinivasa Poojary

Will the Minister of AYUSH be pleased to state:

(a)  the  number  of  complaints  received  against  misleading  claims  made  about  any  herbal  and AYUSH product in advertisements given in any electronic/ print media in the last three years, year-wise;

(b) whether complaints have been received against sale of these herbal and AYUSH products in the market without any authentic clinical trial and if so, the details thereof;

(c) whether the Government has issued directives to the states for appointing Gazetted Officers to monitor advertisements of such medicines, in order to check their veracity regarding AYUSH products and if so, the details thereof; and

(d)  the  extent  to  which  the  Government  has  succeeded  in  checking  these  advertisements  and misleading claims in the country?

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH

## ANSWER (SHRI PRATAP RAO JADHAV)

(a) Ministry of Ayush has formulated a Central Sector Scheme-Ayush Oushadhi Gunvatta evam Uttpadan  Samvardhan  Yojana  (AOGUSY)  in  the  year  2021.  One  of  the  components  of  this scheme  is  Pharmacovigilance  Program  for  Ayurveda,  Siddha,  Unani  &  Homoeopathy  Drugs (ASU  &  H  Drugs).  The  program  is  working  through  a  three-tier  network  of  a  National Pharmacovigilance Centre (NPvCC), Five Intermediary Pharmacovigilance Centres (IPvCs) and 99 Peripheral Pharmacovigilance Centres (PPvCs) established across the country. Through this channel  of  Pharmacovigilance  centers  objectionable/misleading  advertisements  are  regularly

reported  to  the  respective  State  Licensing  Authorities  for  contravening  regulations  under different rules like Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, the cable television network (Regulation) Act 1995, the consumer protection Act, the Emblems and Names (Prevention of  Improper Use) Act, 1950, The Infant Milk Substitutes, Feeding Bottles and  Infant  Foods  (Regulation  of  Production,  Supply  and  Distribution)  Act,  1992,  the  Young Persons (Harmful Publications) Act, 1956 etc., for initiating action against the defaulters. Also, as  per  National  Commission  for  Indian  System  of  Medicine  Regulations  2022  and  National Commission for Homoeopathy regulations 2022, Pharmacovigilance is a mandate component for all the Ayush system of medicine.

Under  the  Pharmacovigilance  program  till  date  a  total  of  38539  misleading  advertisements related to Ayush drugs has been reported, details are attached at Annexure I.

- (b)  As  per  the  information  received  from  various  State/UTs  government,  no  such  compliant against  has  been  received  against  sale  of  Ayush  products  in  the  market  without  any  authentic clinical trial.
- (c) Under section 8 (1) of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, any Gazetted Officer authorized by the State Government may, within the local limits of the  area  for  which  he  is  so  authorized,  to  enter,  search  any  premises  or  examine  or  seize  any record which contravenes any provisions of the Act.

Ministry  of  Ayush  has  also  requested  State  Drug  Licensing  Authorities  and  State  Drug Controllers to take corrective measures for preventing inappropriate advertisement in electronic and print media including newspapers and initiate action as per the section 8 (1) of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

- (d) The  details of the extent to which Government  has  succeeded in checking these advertisements and misleading claims in the country-
- i. Provision of surveillance of ASU&H drugs misleading advertisements has been kept in a Central  Sector  Scheme  Ayush  Oushadhi  Gunavatta  evam  Uttpadan  Samvardhan  Yojana (AOGUSY), for safety monitoring of Ayurvedic, Siddha, Unani and Homeopathy drugs under the pharmacovigilance components. All India Institute of Ayurveda (AIIA), New Delhi under Ministry of Ayush is the National Pharmacovigilance Co-ordination Centre (NPvCC) for the

implementation  of  the  National  Pharmacovigilance  program  for  Ayurveda,  Siddha,  Unani  & Homoeopathy drugs.

- ii. Under  the  Pharmacovigilance  Program  for  ASU  &  H  Drugs  component  of  Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY) scheme, till date a total of 38539 misleading advertisements related to Ayush drugs has been reported to respective state licensing authorities for proper action against the defaulters.
- iii. 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.
- iv. Till  date  approximately  358  brands  of  Ayush  system  have  been  issued  the  notice  for exploiting various regulations. Also, the Press Council of India (PCI) is regularly taking action against the defaulter. The  action  taken  from  2018  upto  July  2024  against  misleading advertisements for treatment and drugs are available in Annexure-II.

## Annexure-I

Details of misleading advertisements related to Ayush drugs noticed by Pharmacovigilance and reported to the SLAs in last three years are as follows:

|   Year | Misleading Advertisements   |
|--------|-----------------------------|
|   2021 | 8144 + 43 (COVID)           |
|   2022 | 7367 + 4 (COVID)            |
|   2023 | 7771                        |
|   2024 | 4372                        |

## State wise total Action Taken by SLA Upto July 2024

| S. No.   | STATE          |   TOTAL SLA ACTION TAKEN |
|----------|----------------|--------------------------|
| 1        | Karnataka      |                       94 |
| 2        | Madhya Pradesh |                       27 |
| 3        | Rajasthan      |                      206 |
| 4        | Tamil Nadu     |                       31 |
| 5        | Uttarakhand    |                       15 |
| 6        | West Bengal    |                        5 |
| Total    | Total          |                      378 |

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## Annexure-II