Lok Sabha Question No. 3113 (UNSTARRED), answered on 2024-08-09
Subject: Misleading Advertisements
Ministry: AYUSH
Asked by: Smt. Pratima Mondal

## GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA UNSTARRED QUESTION NO. 3113 TO BE ANSWERED ON 09 th  AUGUST 2024

## Misleading Advertisements

3113 Smt. Pratima Mondal:

Will the Minister of AYUSH be pleased to state:

- (a)  the  details  of  the  Government's  initiative  to  ensure  the  protection  of  citizens  from misleading advertisements on Ayush drugs; and

(b)  findings  of  the  evaluation  of  false  advertisements  after  omission  of  Rule  170  from  the Drugs and Cosmetic Rules?

## ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAP RAO JADHAV)

- (a) The details of the Government's initiative to ensure the protection of citizens from misleading advertisements on Ayush drugs are as follows:
- I. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules there under encompass the provisions for prohibition of misleading advertisements and exaggerated claims of drugs and medicinal substances including Ayush medicines and for the penalty to be imposed on the defaulters.
- II.  Ministry  of  Ayush  has  formulated  a  Central  Sector  Scheme-Ayush  Oushadhi  Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY). One of the components of this scheme is Pharmacovigilance Program for ASU & H Drugs.  Under this Program the major objectives are  to  keep  vigilance  over  ASU  &  H  drugs  and  to  reduce  the  pollution  of  misleading advertisements.  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 centres objectionable/misleading advertisements

are regularly reported to the respective State Licensing  Authorities for  contravening regulations under different rules like Drug and Magic remedy act 1954, the cable television network act 1995, the consumer protection act, the emblems and names act 1950, the infant milk  substitutes  act  1992,  the  young  person's  act  1956,  the  cable  television  networks  rule 1994 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  Pharmacovigilance  Program  for  ASU  &  H  drugs  consumers  can  lodge complaints either directly or through online portal: https://www.ayushsuraksha.com.

III.  Under the Consumer Protection Act, 2019, misleading advertisement in relation to any product or service is defined as an advertisement, which - (i) falsely describes such product or service;  or  (ii)  gives  a  false  guarantee  to,  or  is  likely  to  mislead  the  consumers  as  to  the nature, substance, quantity or quality of such product or service; or (iii) conveys an express or implied  representation  which,  if  made  by  the  manufacturer  or  seller  or  service  provider thereof,  would  constitute  an  unfair  trade  practice;  or  (iv)  deliberately  conceals  important information.    Under  the  provisions  of  the  Consumer  Protection  Act,  2019,  the  Central Consumer Protection  Authority  (CCPA)  has  been  established  w.e.f  24.07.2020  to  regulate matters  relating  to  violation  of  rights  of  consumers,  unfair  trade  practices  and  false  or misleading advertisements which are prejudicial to the interests of public and consumers as a class.  The  CCPA has notified the Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022 on 9th June, 2022. These guidelines inter-alia provide for; (a) conditions for an advertisement to be non-misleading and valid; (b) certain stipulations in respect of bait advertisements and free claim advertisements; and, (c) duties of manufacturer, service provider, advertiser and advertising agency. These Guidelines shall apply to a manufacturer, service provider or trader whose goods, product or service is the  subject  of  an  advertisement,  or  to  an  advertising  agency  or  endorser  whose  service  is availed for the advertisement of such goods, product or service. The CCPA has also issued an advisory  dated  14.07.2022  regarding  the  sale  of  Ayurvedic,  Siddha  and  Unani  Drugs containing ingredients listed in Schedule E(1) of the Drugs and Cosmetic Rules, 1945 on ecommerce platforms.

(b) Ministry of Ayush vide Gazette notification no - G.S.R. 360(E) dated01/07/2024, omitted rule 170 of Drugs Rules 1945. As per the information received from National Pharmacovigilance  Centre  (NPvCC),  States/  UTs  governments,  details  of  number  of  false

advertisements  noticed  after  omission  of  Rule  170  of  Drugs  Rules,  1945  are  available  at Annexure I.

Annexure I

As per the information received from National Pharmacovigilance Centre (NPvCC), States/ UTs governments details of number of false advertisements noticed after omission of Rule 170 of Drugs Rules, 1945 are as follows:

|   S.No. | Name of the Organization/State /UT        | Reply                                                                                                                                                                                                                                                                                                                                                                                                |
|---------|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | National Pharmacovigilance Centre (NPvCC) | There are no significant changes in number of false advertisements by Ayush manufacturers after omission of Rule 170 of Drugs and Cosmetic Rules, 1945 .                                                                                                                                                                                                                                             |
|       2 | Odisha                                    | No such case has come to notice.                                                                                                                                                                                                                                                                                                                                                                     |
|       3 | Tripura                                   | The evaluation of false advertisements after omission of Rule 170 from the Drugs and Cosmetic Rules has no finding.                                                                                                                                                                                                                                                                                  |
|       4 | Gujarat                                   | 5 cases reported by the Pharmacovigilance center IPVC, Institute of Teaching and Research in Ayurveda, Jamnagar                                                                                                                                                                                                                                                                                      |
|       5 | Puducherry A&B                            | Dr. R. Sridharan, is appointed as Nodal officer (Siddha) for Drugs & Magic Remedies Act. Monitoring of Misleading advertisements done by SRRI (Siddha Regional Research Centre), Puducherry, a peripheral Pharmacovigilance Centre Siddha (PPv-02) CCRS, Ministry of AYUSH, GOI, a Nodal Agency Screening and regular inspection is done by Drugs Inspector, Department of Drugs Control, Puducherry |
|       6 | Uttrakhand                                | For prevention of false advertisements Drugs &Magic Remedies Act already exists.                                                                                                                                                                                                                                                                                                                     |
|       7 | Manipur                                   | False advertisements have not been reported in the State.                                                                                                                                                                                                                                                                                                                                            |
|       8 | Lakshadweep                               | This UT does not have any manufacturing Units/Companies for AYUSH Drug.                                                                                                                                                                                                                                                                                                                              |
|       9 | UP, Lucknow                               | It is too early as Rule-170 has been abolished on 01.07.2024. Therefore, no evaluation could be done in this regard in such a short time.                                                                                                                                                                                                                                                            |
|      10 | Andhra Pradesh                            | It is submitted that the department is evaluating false advertisement in the state.                                                                                                                                                                                                                                                                                                                  |
|      11 | Madhya Pradesh                            | After Omission of 170 Rules, there is no change found on receiving misleading advertisements.                                                                                                                                                                                                                                                                                                        |
|      12 | Karnataka                                 | No increase in number of false advertisements after omission of Rule 170 from Drugs and Cosmetics Rules has been reported in the State of Karnataka.                                                                                                                                                                                                                                                 |
|      13 | Maharashtra                               | The omission of Rule 170 from the Drugs and Cosmetic Rules has been done recently in May 2024 No any change in pattern in misleading advertisements is reported yet. However manufacturers are required to upload as self- declaration on Broadcast Seva Portal of Ministry of                                                                                                                       |

|    |           | information & Broadcasting for TV & Radio and Press Council of India's portal for print/digital/internet media.   |
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| 14 | New Delhi | NIL Information                                                                                                   |

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