Lok Sabha Question No. 2885 (UNSTARRED), answered on 2023-03-17
Subject: Marketing of Fake AYUSH Products
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Vishnu Dayal Ram, Ramya  Haridas

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 2885 TO BE ANSWERED ON 17 TH  MARCH, 2023

## MARKETING OF FAKE AYUSH PRODUCTS

## 2885.   SHRI VISHNU DAYAL RAM: MS. RAMYA HARIDAS:

Will the Minister of AYUSH be pleased to state:

(a) whether there has been an increase in fake/misleading products being marketed as AYUSH products and if so, the details thereof;

- (b) whether the Government has set up a Pharmacopoeia Commission for Indian Medicine and Homoeopathy and if so, the details of the brands and raw products banned by the Commission; (c) whether Government has noticed the dubious claims and advertisement of AYUSH products and if so, the details thereof; (d)  whether  any  protocol  or  guidelines  are  in  force  to  restrict  AYUSH  products  only  for medicinal use and if so, the details thereof; (e)  the  action  taken  by  the  Government  in  cases  of  false  advertising/marketing  of  products  as AYUSH products; and (f)  whether  there  is  a  monitoring  mechanism  in  place  to  prosecute/penalise  second-time offenders  engaging  in  false  marketing/advertising  and  if  so,  the  details  of  such  second-time

offenders, State-wise?

## ANSWER THE MINISTER OF AYUSH (SHRI SARBANANDA SONOWAL)

(a) As  prescribed  in  Drugs  and  Cosmetics  Act  1940  and  Rules  1945  made  thereunder, enforcement of the legal provisions pertaining to Quality Control and issuance of drug license of Ayurveda,  Siddha,  Unani  and  Homoeopathic  drugs,  is  vested  with  the  State  drug  Controllers/ State  Licensing  Authorities  appointed  by  the  concerned  State/  Union  Territory  Government.

State government of Andhra Pradesh (A.P.) has informed that following fake/ misleading products have come to their notice-

- i. Vata  Nivarini  Gulika  &  Dhanwantari  Gulika,  manufactured  by  M/s  Ijas  Herbals  of Kurnool, A.P. (Mfg.License no. R-1909/Ayur.) & M/s Susruta Ayurvedics of Ravulapalem,  W.G.  Dist.  Of  A.P.  (Mfg.  License  A-1610/Ayur.  for  Arhtirits  Pains). Casses has been filed under Section 33-E, EE and EEA, the licenses were cancelled and the units have been seized.
- ii. Sri  Anandaiah's  Covid  Medicine  (P,K,LF  &  Eye  drops)  -  Activity  is  stopped  and  the department has furnished all the relevant documents to Hon'ble High Court of A.P. in connection with a case filled by others.

State government  of Kerala has informed that the number  of  cases filed regarding fake/misleading  products  has  been  increased  compared  to  previous  years.  From  2013,  19 complaints for misleading advertisement and 11 cases for Drugs &  Magic  Remedies (Objectionable Advertisements) Act, 1954 & Rules there under have been reported.

(b)  Yes  Sir  and  Madam.    Government  of  India  has  merged  three  organizations  namely; Pharmacopoeia Laboratory of Indian Medicine (PLIM), Homoeopathic Pharmacopoeia Laboratory (HPL) [both central government laboratories under Ministy of Ayush and deals the matter  pertaining  to  drug  testing  and  Pharmacopoeial  Standardization  of  drug  used  in  Indian System (Ayurveda, Siddha Unani) of medicine and Homoeopathy respectively] and Pharmacopoeia Commission for Indian Medicine & Homoeopathy an autonomous body under M/o  Ayush, and re-established as Pharmacopoeia  Commission for Indian Medicine  & Homoeopathy  (PCIM&H),  a  subordinate  office  under  Ministry  of    Ayush  vide  Gazette Notification No. CG-DL-W-20072020-220580, dated 06.07.2020.

The  prime  mandate  of  re-established  PCIM&H  on  behalf  of  M/o  Ayush  to  lays  down Pharmacopoeial  Standards  and  Formulary  specifications  for  ASU&H  drugs,  which  serve  as official compendia for ascertaining the identity, purity and strength of the drugs included therein. Further, commission is acting as appellate laboratory for testing of ASU&H drugs.

(c) to (e) Yes. As prescribed in Drugs and Cosmetics Act 1940 and Rules 1945 made thereunder, enforcement of the legal provisions pertaining to Quality Control and issuance of drug license of Ayurveda,  Siddha,  Unani  and  Homoeopathic  drugs,  is  vested  with  the  State  drug  Controllers/

State  Licensing  Authorities  appointed  by  the  concerned  State/  Union  Territory  Government. State/UT Governments are empowered to enforce the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 & Rules there under and Rule 170 of the Drugs & Cosmetics Rules, 1945 pertaining to control and prohibition of misleading advertisements and exaggerated  claims  of  drugs.  Accordingly,  directives  have  been  issued  to  the  States/UTs  for appointing Officers to enter, search any premises or examine or seize any record related to the alleged misleading or improper advertisements and initiate action against the cases of default.

Pharmacovigilance  Centres  for  Ayurveda,  Siddha,  Unani  and  Homoeopathy  (ASU&H) Drugs set up in different parts of the country under the Central Scheme of Ministry of Ayush are mandated to monitor and report the misleading advertisements to the respective State Regulatory Authorities.  A  three  tier  structure  comprising  of  a  National  Pharmacovigilance  Co-ordination Centre (NPvCC), Intermediary Pharmacovigilance Centres (IPvCs) and Peripheral Pharmacovigilance Centres (PPvCs) is established. 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.  Objectionable advertisements are being reported to the respective State Licensing Authorities by PPvC at regular intervals.

As per the information received from State/UT government, the details of dubious claims and advertisement of AYUSH products and the action taken by the Government in cases of false advertising/marketing of products as AYUSH products are as follows -

|   S.no. | Name of the State/UT   | the details of dubious claims and advertisement of AYUSH products   | Action taken by the State/ UT Government for false advertising/marketing of products as AYUSH products                                                                                                                                                                                                                                                                                                                  |
|---------|------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Tamil Nadu             | 01, misleading advertisement of Thamara-20                          |  License of Asthra Power Tonic Capsule & Cream of M/ s. Pee Gee Pharma, No. 2/143, Sivadapuram, S.O, Salem - 636 307 had been suspended for one month for illegal advertisement with false claim.  License of Boraxine Ointment of M/ s. Ancient Pharma, Door No. 4/150, Virathanur Road, Ayyanarpuram, Panaiyur Post, Madurai - 625 009 had been suspended for one month for illegal advertisement with false claim. |

|    |             |                                                                                                                                                            |  License of Segro Plus Capsule, Musli Segro Capsule & Kamana Capsule of M/ s. Shankaralaya Herbals Pvt Ltd, No. 9, 10th Cross Street, Mangalanagar, Chennai - 116 had been suspended for one month for illegal advertisement with false claim.   |  License of Segro Plus Capsule, Musli Segro Capsule & Kamana Capsule of M/ s. Shankaralaya Herbals Pvt Ltd, No. 9, 10th Cross Street, Mangalanagar, Chennai - 116 had been suspended for one month for illegal advertisement with false claim.   |
|----|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|  2 | Karnataka   | Drug Inspectors have issued 1409 notices to erring advertisers for the misleading claims in their advertisements.                                          | Government officers have been notified under Section (8) of Drugs & Magic Remedies (OA) Act, 1954 to initiate action against advertisers issuing misleading and objectionable advertisement.                                                      | Government officers have been notified under Section (8) of Drugs & Magic Remedies (OA) Act, 1954 to initiate action against advertisers issuing misleading and objectionable advertisement.                                                      |
|  3 | Maharashtra | 73 objectionable advertisements of Ayush products have been detected since 2020.                                                                           | Action taken since 2020 Notice issued, investigation in progress Manufacture informed that they have stopped advertisement Objectionable contents removed Investigation in progress Prosecution filed No contravention                            | No. of manufacturing companies                                                                                                                                                                                                                    |
|  3 | Maharashtra | 73 objectionable advertisements of Ayush products have been detected since 2020.                                                                           | Action taken since 2020 Notice issued, investigation in progress Manufacture informed that they have stopped advertisement Objectionable contents removed Investigation in progress Prosecution filed No contravention                            | 28                                                                                                                                                                                                                                                |
|  3 | Maharashtra | 73 objectionable advertisements of Ayush products have been detected since 2020.                                                                           | Action taken since 2020 Notice issued, investigation in progress Manufacture informed that they have stopped advertisement Objectionable contents removed Investigation in progress Prosecution filed No contravention                            | 11                                                                                                                                                                                                                                                |
|  3 | Maharashtra | 73 objectionable advertisements of Ayush products have been detected since 2020.                                                                           | Action taken since 2020 Notice issued, investigation in progress Manufacture informed that they have stopped advertisement Objectionable contents removed Investigation in progress Prosecution filed No contravention                            | 10                                                                                                                                                                                                                                                |
|  3 | Maharashtra | 73 objectionable advertisements of Ayush products have been detected since 2020.                                                                           | Action taken since 2020 Notice issued, investigation in progress Manufacture informed that they have stopped advertisement Objectionable contents removed Investigation in progress Prosecution filed No contravention                            | 08                                                                                                                                                                                                                                                |
|  3 | Maharashtra | 73 objectionable advertisements of Ayush products have been detected since 2020.                                                                           | Action taken since 2020 Notice issued, investigation in progress Manufacture informed that they have stopped advertisement Objectionable contents removed Investigation in progress Prosecution filed No contravention                            | 13                                                                                                                                                                                                                                                |
|  3 | Maharashtra | 73 objectionable advertisements of Ayush products have been detected since 2020.                                                                           | Action taken since 2020 Notice issued, investigation in progress Manufacture informed that they have stopped advertisement Objectionable contents removed Investigation in progress Prosecution filed No contravention                            | 02                                                                                                                                                                                                                                                |
|  3 | Maharashtra | 73 objectionable advertisements of Ayush products have been detected since 2020.                                                                           | Stock seized and                                                                                                                                                                                                                                  | 01                                                                                                                                                                                                                                                |
|  4 | Manipur     | under process 08 misleading advertisement noticed by PPvC.                                                                                                 | under process 08 misleading advertisement noticed by PPvC.                                                                                                                                                                                        | under process 08 misleading advertisement noticed by PPvC.                                                                                                                                                                                        |
|  5 | Kerala      | Ayurveda Drug inspectors are constantly monitoring for any dubious claims and advertisement. From 2013, 19 complaints of advertisements have been noticed. | Legal action to 11 manufacturers has been taken against false advertising/ marketing of Ayurveda, Siddha and Unani products                                                                                                                       | Legal action to 11 manufacturers has been taken against false advertising/ marketing of Ayurveda, Siddha and Unani products                                                                                                                       |
|  6 | Mizoram     | NIL                                                                                                                                                        | NIL                                                                                                                                                                                                                                               | NIL                                                                                                                                                                                                                                               |
|  7 | Odisha      | NIL                                                                                                                                                        | NIL                                                                                                                                                                                                                                               | NIL                                                                                                                                                                                                                                               |
|  8 | Puducherry  |                                                                                                                                                            | Nodal officer has been appointed for Drugs & Magic Remedies (OA) 1954.                                                                                                                                                                            | the Act,                                                                                                                                                                                                                                          |

|   9. | Gujarat           | Year                                                                                                                                                                |                                                                                                                                                                     | No. of advertisement in respect of DMR Act, 1954.                                                                                                                   | Warning issued                                                                                                                                                                                                              | Show Cause notice issued                                                                                                                                                                                                    | Sent for inquiry/ referred                                                                                                                                                                                                  |
|------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|    9 | Gujarat           | 2020                                                                                                                                                                |                                                                                                                                                                     | 24                                                                                                                                                                  | 11                                                                                                                                                                                                                          | 8                                                                                                                                                                                                                           | 5                                                                                                                                                                                                                           |
|    9 | Gujarat           | 2021                                                                                                                                                                | 6                                                                                                                                                                   | -                                                                                                                                                                   |                                                                                                                                                                                                                             | 2                                                                                                                                                                                                                           | 4                                                                                                                                                                                                                           |
|    9 | Gujarat           | 2022                                                                                                                                                                | 4                                                                                                                                                                   | -                                                                                                                                                                   |                                                                                                                                                                                                                             | 2                                                                                                                                                                                                                           | 2                                                                                                                                                                                                                           |
|   10 | Andaman & Nicobar | One advertisement with dubious claim of Ayush Product over Internet (by the manufacturer based in Haryana State) has been noticed.                                  | One advertisement with dubious claim of Ayush Product over Internet (by the manufacturer based in Haryana State) has been noticed.                                  | One advertisement with dubious claim of Ayush Product over Internet (by the manufacturer based in Haryana State) has been noticed.                                  |  Matter has been reported to intermediary pharmacovigilance Centre jamnagar and PPvC, Haryana to take up with the concerned authority.  Regular awareness programs on DMR (OA) Act, 1954 have been                        |  Matter has been reported to intermediary pharmacovigilance Centre jamnagar and PPvC, Haryana to take up with the concerned authority.  Regular awareness programs on DMR (OA) Act, 1954 have been                        |  Matter has been reported to intermediary pharmacovigilance Centre jamnagar and PPvC, Haryana to take up with the concerned authority.  Regular awareness programs on DMR (OA) Act, 1954 have been                        |
|   11 | Uttar Pradesh     | 04 dubious claims/ advertisement have been noticed.                                                                                                                 | 04 dubious claims/ advertisement have been noticed.                                                                                                                 | 04 dubious claims/ advertisement have been noticed.                                                                                                                 | Cognizance of the case, direction have been to the concern authority for taking necessary action against the defaulters and alleged manufacturing/ advertisers under the DMR (OR) Act, 1954 and Drugs &Cosmetics Act, 1940. | Cognizance of the case, direction have been to the concern authority for taking necessary action against the defaulters and alleged manufacturing/ advertisers under the DMR (OR) Act, 1954 and Drugs &Cosmetics Act, 1940. | Cognizance of the case, direction have been to the concern authority for taking necessary action against the defaulters and alleged manufacturing/ advertisers under the DMR (OR) Act, 1954 and Drugs &Cosmetics Act, 1940. |
|   12 | Andhra Pradesh    | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | As per the provisions of DMR (OR) Act, 1954                                                                                                                                                                                 | As per the provisions of DMR (OR) Act, 1954                                                                                                                                                                                 | As per the provisions of DMR (OR) Act, 1954                                                                                                                                                                                 |
|   13 | Jammu & Kashmir   | There is no separate Ayush Drug Controlling Authority which can monitor herbal drug companies and any misleading / objectionable advertisements under Ayush sector. | There is no separate Ayush Drug Controlling Authority which can monitor herbal drug companies and any misleading / objectionable advertisements under Ayush sector. | There is no separate Ayush Drug Controlling Authority which can monitor herbal drug companies and any misleading / objectionable advertisements under Ayush sector. | There is no separate Ayush Drug Controlling Authority which can monitor herbal drug companies and any misleading / objectionable advertisements under Ayush sector.                                                         | There is no separate Ayush Drug Controlling Authority which can monitor herbal drug companies and any misleading / objectionable advertisements under Ayush sector.                                                         | There is no separate Ayush Drug Controlling Authority which can monitor herbal drug companies and any misleading / objectionable advertisements under Ayush sector.                                                         |
|   14 | Delhi             | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                                                                         | NIL                                                                                                                                                                                                                         | NIL                                                                                                                                                                                                                         |
|   15 | Tripura           | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                                                                         | NIL                                                                                                                                                                                                                         | NIL                                                                                                                                                                                                                         |
|   16 | Goa               | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                                                                         | NIL                                                                                                                                                                                                                         | NIL                                                                                                                                                                                                                         |
|   17 | Lakshadweep       | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                                                                         | NIL                                                                                                                                                                                                                         | NIL                                                                                                                                                                                                                         |
|   18 | Ladakh            | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | The department will act against the false advertisement / marketing of product as                                                                                                                                           | The department will act against the false advertisement / marketing of product as                                                                                                                                           | The department will act against the false advertisement / marketing of product as                                                                                                                                           |
|   19 | Meghalaya         | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                                                                         | NIL                                                                                                                                                                                                                         | NIL                                                                                                                                                                                                                         |

(f)  State/UT  Governments  are  empowered  to  enforce  the  provisions  of  Drugs  &  Magic Remedies (Objectionable Advertisements) Act, 1954 & Rules there under and Rule 170 of the Drugs &  Cosmetics Rules, 1945 pertaining to control and prohibition of misleading advertisements and exaggerated claims of drugs. As per section 7 of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 -

Whoever contravenes any of the provisions of this Act [or the rules made there under] shall, on conviction, be punishable a) in the case of a first conviction, with imprisonment which may extend to six months, or with fine, or with both; b) in the case of a subsequent conviction, with imprisonment which may extend to one year, or with fine, or with both.

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