Lok Sabha Question No. 3009 (UNSTARRED), answered on 2024-12-13
Subject: Drugs and Cosmetics Act
Ministry: AYUSH
Asked by: Shri Raja Ram Singh

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 3009 TO BE ANSWERED ON 13 th  December 2024

## 'Drugs and Cosmetics Act'

## 3009. Shri Raja Ram Singh:

Will the Minister of Ayush be pleased to state: (a) whether the Government has received any complaints with regards to Rule 170 of Drugs and Cosmetics Act, 1945 prohibiting misleading advertisements related to Ayurveda, Yoga, Unani, Siddha, and Homeopathy (AYUSH) products and if so, the details thereof, (b) the details of the companies who have violated the Rule 170 of Drugs and Cosmetics Act, 1945, company-wise; (c) whether any penalties have been imposed against the companies registered under Ministry of AYUSH which have violated the Rule 170 of Drugs and Cosmetics Act, 1945 and if so, the details thereof, and (d)  the  details  of  the  action  taken  by  the  Government  against  the  companies  which  have violated the Rule 170 of Drugs and Cosmetics Act, 1945?

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

(a) 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.

As per the information  received  from  All  India  Institute  of  Ayurveda  (AIIA),  New Delhi regarding Pharmacovigilance Program for Ayurveda, Siddha, Unani and Homeopathy drugs (ASU&H), the detail of number of complaints with regards to Rule 170 of the Drugs Rules,  1945  prohibiting  misleading  advertisements  related  to  Ayurveda,  Yoga,  Unani, Siddha, and Homeopathy (AYUSH) products is available at Annexure-I.

(b)  As  per  the  information  received  from  Pharmacovigilance  Program  for  ASU&H  drugs, AIIA, New Delhi and State/UT's licensing authorities, the details  of  the  companies  which have violated the Rule 170 of the Drugs Rules, 1945 is available at Annexure-II.

(c)  and (d) Enforcement of legal provisions under the Drugs and Cosmetics Act, 1940 and rules made  thereunder pertaining to  ASU&H  drugs  is  vested with the State  Drug Controllers/State Licensing Authorities appointed by the concerned State/UT government. As per the information received from State/UT's licensing authorities, the details of the action taken/penalty by the Government against the companies which have violated the Rule 170 of the Drugs Rules, 1945 is available at Annexure III.

As per the information received from Pharmacovigilance Program for ASU&H drugs, AIIA, the details of number of complaints received with regards to Rule 170 of the Drugs Rules, 1945 prohibiting misleading advertisements related to Ayurveda, Yoga, Unani, Siddha and Homeopathy (AYUSH) products from January to October 2024 is as follows:

|   S. No. | Month   |   No. of advertisements |
|----------|---------|-------------------------|
|        1 | Jan-24  |                     121 |
|        2 | Feb-24  |                     129 |
|        3 | Mar-24  |                     130 |
|        4 | Apr-24  |                       4 |
|        5 | May-24  |                      67 |
|        6 | Jun-24  |                      52 |
|        7 | Jul-24  |                      11 |
|        8 | Aug-24  |                       0 |
|        9 | Sep-24  |                       3 |
|       10 | Oct-24  |                      11 |

As per the information received from Pharmacovigilance Program for ASU&H drugs, AIIA and  State/UT's  licensing  authorities,  the  details  of  the  companies  which  have  violated  the Rule  170  of  the  Drugs  Rules,  1945,  company-wise  from  January  to  October  2024  are  as follows :

|   S. No. | Name of the State/ UT and others                                                     | Details of companies which have violated the Rule 170 of the Drugs Rules, 1945                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |
|----------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|        1 | Pharmacovigilance Program for ASU&H drugs, AIIA ( Data from January to October 2024) | 1)Amar Products 2) Amrit Noni Products 3) Dr. Asma Herbals 4) B.C. Hasaram and Sons 5) Baidyanath 6) Bhargava 7) Charutbhuj Pharma 8) Dhootpapeshwar 9) Divisa 10) Dr Dassan 11) Dr Juneja's 12) Dr Nutricio 13) Dr Thanki's 14) Emami Ltd. 15) Gynoveda 16) Jagat Pharma 17) Jolly Pharmacy 18) Kapiva 19) Tulison Pharma 20) Krishna Herbals 21) Orichem Drugs & Pharmaceuticals 22) Pankajakasturi Herbal India 23) Patanjali 24) Rajvaidya Ayurveda 25) Satrishi Herbals 26) SBS Bio-tech 27) Shankar Pharmacy 28) Shree Maruti Harbals 29) Swaarnim Nature Science Ltd. 30) Techno Pharma 31) Trichup Brand 32) Dr. Trust Healthcare 33) Well 'n' care 34) Zandu Care 35) Zee Pharmacueticals 36) Zocveda Wellness |
|        2 | Tamil Nadu (2019)                                                                    | 1. M/s. Pee Gee Pharma, No. 2/143, Sivadapuram, S.O, Salem - 636 307 2. M/s. Ancient Pharma, Door No. 4/150, Virathanur Road, Ayyanarpuram, Panaiyur Post, Madurai - 625 009 3. M/s. Shankaralaya Herbals Pvt Ltd, No. 9, 10th Cross Street, Mangalanagar, Chennai-116                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
|        3 | Gujarat (May 2024-October 2024)                                                      | 1. Dr. Vasishtha's Ayu Remedies 2. Sheth Brothers 3. Emami Pvt Ltd 4. Vasu Healthcare,Vadodara 5. S B Biotech 6 Vivvan Herbals, Ahmedabad 7.Shree Shankar Ayurvedic Pharmacy, Ahmedabad 8. Shreejee Remedies, Ahmedabad                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |
|        4 | Delhi                                                                                | May 2020: 1. M/s Rajvaidya Shital Prasad &Sons May 2024 till date: 1.M/s Saintlife Pharmaceuticals Ltd. 2.M/s Divisa Herbals Pvt. Ltd. 3.M/s Trust Health Care                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |

|    |                   | 4. M/s Allen Laboratories Ltd. 5.M/s Zandu Pharmaceuticals Ltd., 6.M/s Rajvaidya Shital Prasad &Sons 7.M/s Oriental Chemical Works 8. M/s Dabur India Ltd. 9.M/s Shree Baidyanath Ayurved Bhawan 10.M/s New Royal Products 11.M/s Dehlvi Remedies Pvt. Ltd. 12. M/s Apsara Herbals 13.M/s Rex Remedies Ltd. 14.M/s Rahat Herbal Industries 15.M/s Emami Limited 15.M/s Khojati Herbals 16.M/s Vicco Laboratories 17 . M/s Sana Herbals (P) Ltd. 18. M/s Hamdard Laboratories (INDIA) 19. M/s Dehlvi Naturals   |
|----|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|  5 | Odisha            | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
|  6 | Kerala            | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
|  7 | Karnataka         | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
|  8 | Mizoram           | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
|  9 | Haryana           | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| 10 | Arunachal Pradesh | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| 11 | Jharkhand         | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| 12 | Assam             | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| 13 | West Bengal       | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |

As per the information  received  from  State/UT's  licensing  authorities,  the  details  of  the action taken by the Government against the companies which have violated the Rule 170 of the Drugs Rules, 1945 is as follows:

|   S. No. | Name of the State/ UT      | Details of the penalties/action taken against the                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | Details of the penalties/action taken against the                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |
|----------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|        1 | Tamil Nadu                 | companies 1. 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. 2. 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. 3. License of Segro Plus Capsule, MusliSegro 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. | companies 1. 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. 2. 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. 3. License of Segro Plus Capsule, MusliSegro 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 | Gujarat                    | Warning issued to the following companies: 1. Dr. Vasishtha's Ayu Remedies 2. Sheth brothers 3. Emami Pvt Ltd 4. Vasu Healthcare,Vadodara 5. S B Biotech 6 Vivvan Herbals, Ahmedabad 7.Shree Shankar Ayurvedic Pharmacy, Ahmedabad Supreme Court notice issued to:                                                                                                                                                                                                                                                                                                                                                                                                        | Warning issued to the following companies: 1. Dr. Vasishtha's Ayu Remedies 2. Sheth brothers 3. Emami Pvt Ltd 4. Vasu Healthcare,Vadodara 5. S B Biotech 6 Vivvan Herbals, Ahmedabad 7.Shree Shankar Ayurvedic Pharmacy, Ahmedabad Supreme Court notice issued to:                                                                                                                                                                                                                                                                                                                                                                                                        |
|        3 | Delhi                      | Show cause notices, warnings and further necessary actions along with intimation to the concerned State Licensing Authorities were initiated and legal opinion in                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | Show cause notices, warnings and further necessary actions along with intimation to the concerned State Licensing Authorities were initiated and legal opinion in                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |
|        4 | Karnataka (2019-till date) | some cases is also sought for. Division No. of notices issued for violation of Rule 170 of Drugs Rules, 1945 Kalaburagi 0 Belagavi 143 Mysuru 280 Bengaluru 139 Bengaluru Headquarters 52 Total                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | the                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
|        4 | Karnataka (2019-till date) | some cases is also sought for. Division No. of notices issued for violation of Rule 170 of Drugs Rules, 1945 Kalaburagi 0 Belagavi 143 Mysuru 280 Bengaluru 139 Bengaluru Headquarters 52 Total                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | 614                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
|        4 | Karnataka (2019-till date) | some cases is also sought for. Division No. of notices issued for violation of Rule 170 of Drugs Rules, 1945 Kalaburagi 0 Belagavi 143 Mysuru 280 Bengaluru 139 Bengaluru Headquarters 52 Total                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
|        4 | Karnataka (2019-till date) | some cases is also sought for. Division No. of notices issued for violation of Rule 170 of Drugs Rules, 1945 Kalaburagi 0 Belagavi 143 Mysuru 280 Bengaluru 139 Bengaluru Headquarters 52 Total                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
|        4 | Karnataka (2019-till date) | some cases is also sought for. Division No. of notices issued for violation of Rule 170 of Drugs Rules, 1945 Kalaburagi 0 Belagavi 143 Mysuru 280 Bengaluru 139 Bengaluru Headquarters 52 Total                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
|        4 | Karnataka (2019-till date) | some cases is also sought for. Division No. of notices issued for violation of Rule 170 of Drugs Rules, 1945 Kalaburagi 0 Belagavi 143 Mysuru 280 Bengaluru 139 Bengaluru Headquarters 52 Total                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
|        4 | Karnataka (2019-till date) | some cases is also sought for. Division No. of notices issued for violation of Rule 170 of Drugs Rules, 1945 Kalaburagi 0 Belagavi 143 Mysuru 280 Bengaluru 139 Bengaluru Headquarters 52 Total                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |

|   5. | Odisha            | NIL   |
|------|-------------------|-------|
|    6 | Kerala            | NIL   |
|    7 | Mizoram           | NIL   |
|    8 | Haryana           | NIL   |
|    9 | Arunachal Pradesh | NIL   |
|   10 | Jharkhand         | NIL   |
|   11 | Assam             | NIL   |
|   12 | West Bengal       | NIL   |

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