Lok Sabha Question No. 297 (STARRED), answered on 2025-08-08
Subject: AYUSH Drugs in Rural Markets
Ministry: AYUSH
Asked by: Adv Priya Saroj

## GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA STARRED QUESTION NO. 297

## TO BE ANSWERED ON 08 th  AUGUST 2025

' AYUSH Drugs in Rural Markets '

## 297. Adv Priya Saroj:

Will the Minister of AYUSH be pleased to state:

- (a)  the  existing  regulatory  framework  and  mechanisms  for  ensuring  the  quality,  safety  and efficacy of AYUSH drugs and products available in rural markets across the country and the number of drug testing laboratories dedicated to AYUSH products, State/UT-wise;
- (b)  the  total  number  of  cases  of  substandard,  misbranded  and  adulterated  AYUSH  drugs reported from rural areas in the last three financial years, State-wise and the punitive actions taken against the manufacturers and distributors of such drugs;
- (c)  the  details  of  initiatives  taken  by  the  Government  to  strengthen  pharmacovigilance  of AYUSH drugs, especially in rural areas; and

(d) the measures being adopted by the Government to promote Good Manufacturing Practices (GMP) among small and medium-scale AYUSH drug manufacturers operating in rural and semi-urban  areas  and  the  details  of  financial  or  technical  assistance  provided  for  their compliance?

## ANSWER

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

(a) to (d) A statement is laid on the Table of the House.

## THE  STATEMENT  REFERRED  TO  IN  REPLY  TO  LOK  SABHA  STARRED QUESTION NO. 297 FOR 08th AUGUST 2025.

- (a) The details of existing regulatory framework and mechanisms for ensuring the quality, safety and efficacy of Ayush drugs and products available in rural markets across the country  and  the  number  of  drug  testing  laboratories  dedicated  to  Ayush  products, State/UT-wise are as follows: -
1. The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions  for  Ayurvedic,  Siddha,  Sowa-Rigpa,  Unani,  and  Homoeopathy  drugs. Provisions relating to Ayurveda, Siddha and Unani Drugs are contained in Chapter IVA and  Schedule-  I  of  the  Drugs  and  Cosmetics  Act,  1940  and  in  Rules  151  to  169, Schedules E(I), T & TA of the Drugs Rules, 1945. Further, second schedule (4A) of the Drugs and Cosmetics Act, 1940 provides standards for Homoeopathic drugs and Rules 2dd, 30AA, 67 (C-H), 85 (A to I), 106-A, Schedule K, Schedule M-I of the Drugs Rules, 1945 pertain to Homoeopathic drugs. It is mandatory for the manufacturers to adhere to the prescribed requirements in  compliance with the Good Manufacturing Practices (GMP) as per Schedule  T  &  Schedule  M-I  of  Drugs  Rules,  1945  including  safety, effectiveness and quality standards of drugs given in the respective pharmacopoeia.
2. Drug Inspectors collect medicine samples regularly from manufacturing firms or sale shops within their jurisdiction and send them to Drug Testing Laboratory under Drug Control department for quality testing and if any sample is found to be 'Not of Standard Quality', appropriate action is initiated such as preventing the sale of the products from the market and appropriate legal actions as per Drugs and Cosmetics Act, 1940 and Rules made thereunder.
3. Pharmacopoeia  Commission  for  Indian  Medicine  &  Homoeopathy  (PCIM&H), subordinate office under Ministry of Ayush lays down the formulary specifications and pharmacopoeial standards for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs which serves as official compendia for ascertaining the quality (identity, purity and strength) of the ASU&H drugs. As per the Drugs & Cosmetics Act, 1940 and rules thereunder, the compliance to this quality standards are mandatory for the production

of ASU&H drugs being manufactured in India. So far, 2269 quality standards on raw materials  (single  drugs  of  plant/  animal/  mineral/  metal/  chemical  origin)  used  in ASU&H  drugs,  426  quality  standards  of  ASU  formulations  and  2799  formulary specifications of ASU drugs has been published.

4. PCIM&H  also  acts  as  the  Central  Drugs  Laboratory  for  Indian  Medicine  and Homoeopathy  for  the  purpose  of  testing  or  analysis  of  ASU&H  Drugs.  Further,  it imparts  Capacity  Building  Trainings  at  regular  interval  for  standardization/quality control/  testing  or  analysis  of  ASU&H  drugs  to  Drug  Regulatory  Authorities,  State Drug Testing Laboratories (Drug Analyst) and other stakeholders on quality control of ASU&H drugs on laboratory techniques and methods used to maintain the quality of ASU&H drugs.
5. Drug Testing Laboratories are being recognised under Rule 160 A to J of the Drugs Rules,  1945  for  carrying  out  such  tests  of  identity,  purity,  quality  and  strength  of Ayurvedic,  Siddha,  Sowa-Rigpa,  Unani  and  Homoeopathy  drugs.  As  on  date,  108 private laboratories are approved or licensed under the provisions of Drugs Rules, 1945 for  manufacturers. 34 Drug Testing Laboratories of State/UTs are testing quality of Ayurvedic, Siddha, Sowa-Rigpa, Unani and Homoeopathy drugs and raw materials for legal samples. The details of number of drug testing laboratories dedicated to Ayush products, State/UT-wise are available at Annexure-I.
6. Ministry of Ayush has implemented Central Sector Scheme Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) to support Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards under one of the components.
7. Pharmacovigilance Program for Ayurveda, Siddha, Unani, and Homoeopathy (ASU & H) Drugs is one of the components under the AOGUSY Scheme of Ministry of Ayush. This  is  established  with  an  objective  of  improving  patient  healthcare  and  safety  in relation to the use of medicines, developing culture of documenting adverse effects, promoting education and training in Pharmacovigilance, and surveillance of misleading advertisements appearing in the print and electronic media.

- (b) As per the information received from states/UTs governments, the details of the total number of cases of substandard, misbranded and adulterated Ayush drugs reported from rural areas in the last three financial years, State-wise and the punitive actions taken against the manufacturers and distributors of such drugs are attached at Annexure-II.
- (c) And (d) The details of initiatives taken by the Government to strengthen pharmacovigilance of Ayush drugs, especially in rural areas; and the measures being adopted by the Government to promote Good Manufacturing Practices (GMP) among small and medium-scale Ayush drug manufacturers operating in rural and semi-urban areas and the details of financial or technical assistance provided for their compliance are as follows: -
1.  Ministry  of  Ayush  has  implemented  Central  Sector  Scheme  Ayush  Oushadhi Gunvatta  Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY).  The  total  financial allocation  to  this  scheme  is  Rs.  122.00  crores  for  five  years.  The  components  of AOGUSY scheme are as follows -

A. Strengthening  and  up-gradation  of  Ayush  Pharmacies  and  Drug  Testing Laboratories to achieve higher standards.

B. Pharmacovigilance  of  ASU&H  drugs  including  surveillance  of  misleading advertisements.

C. Strengthening of Central and State regulatory frameworks including Technical Human Resource & Capacity Building programs for Ayush drugs.

D. Support for development of standards and accreditation/certification of Ayush products  &  materials  in  collaboration  with  Bureau  of  Indian  Standards  (BIS), Quality  Control  of  India  (QCI)  and  other  relevant  scientific  institutions  and industrial R&D centres.  Detailed guidelines of AOGUSY scheme are available at https://ayush.gov.in/resources/pdf/schemes/aoushdhi.pdf

2. The  Pharmacovigilance  Program  for  Ayurvedic,  Siddha,  Unani  and  Homoeopathy (ASU  &  H)  Drugs  has  been  implemented  under  Central  Sector  Scheme  Ayush Oushadhi  Gunavatta  Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY),  which  work through a three-tier network of a National Pharmacovigilance Centre (NPvCC), Five Intermediary Pharmacovigilance Centers (IPvCs) and 97 Peripheral Pharmacovigilance Centers (PPvCs) established across the country. These centres are mandated to monitor and report misleading advertisements to the respective State Regulatory Authorities for

suitable action against the defaulter. Objectives of this program is to keep vigilance over Ayush drugs and to reduce misleading advertisements to ensure the consumer protection  and  prevent  the  dissemination  of  unverified  claims  by  Ayush  product manufacturers.

3. To strengthen pharmacovigilance of Ayush drugs, regular awareness programs have been conducted throughout the nation under the pharmacovigilance program for ASU & H drugs for practitioners, healthcare workers and other different cohort including general public to disseminate the awareness regarding patient safety. Till date 3464 awareness programs have been conducted with 328709 beneficiaries across the country. Details are available as Annexure III.
4. Ministry of Ayush has developed and launched an IT enabled online portal 'Ayush Suraksha'  for  Ayush  Health  care  professionals  and public  to  track  the  reported misleading advertisements (MLAs)/Objectionable Advertisements (OAs) and Adverse Drug Reactions (ADRs) on 30th May 2025.
5. Further Ministry of Ayush encourages following certifications of Ayush products as per details below: -
- An  Ayush  vertical  has  been  created  in  Central  Drugs  Standard  Control Organization (CDSCO) to strengthen regulatory measures ensuring safety and quality of Ayush drugs. Further, CDSCO issues WHO Certificate of Pharmaceutical Product (WHO-CoPP) to Ayush drugs having compliance to such standards.
- Quality  Certifications  Scheme  implemented  by  the  Quality  Council  of  India (QCI)  for  grant  of  AYUSH  standard  and  premium  mark  to  Ayurvedic,  Siddha  and Unani products on the basis of third-party evaluation of quality in accordance with the status of compliance to domestic and international standards.

*****

## Annexure-I

The details of number of drug testing laboratories dedicated to AYUSH products, State/UTwise are as follows: -

|   S. No. | State/UT           |   Government/UTs drug testing laboratories |   Private drug testing laboratories approved under Rule 160 A to J of Drugs Rules 1945. |
|----------|--------------------|--------------------------------------------|-----------------------------------------------------------------------------------------|
|        1 | Andhra Pradesh     |                                         01 |                                                                                      00 |
|        2 | Arunanchal Pradesh |                                         01 |                                                                                      00 |
|        3 | Assam              |                                         01 |                                                                                      00 |
|        4 | Bihar              |                                         01 |                                                                                      00 |
|        5 | Chhattisgarh       |                                         01 |                                                                                      00 |
|        6 | Gujarat            |                                         01 |                                                                                      06 |
|        7 | Haryana            |                                         01 |                                                                                      09 |
|        8 | Himachal Pradesh   |                                         01 |                                                                                      03 |
|        9 | Jammu and Kashmir  |                                         01 |                                                                                      00 |
|       10 | Jharkhand          |                                         01 |                                                                                      00 |
|       11 | Karnataka          |                                         01 |                                                                                      09 |
|       12 | Kerala             |                                         02 |                                                                                      09 |
|       13 | Madhya Pradesh     |                                         01 |                                                                                      06 |
|       14 | Maharashtra        |                                         02 |                                                                                      13 |
|       15 | Manipur            |                                         01 |                                                                                      00 |
|       16 | Mizoram            |                                         01 |                                                                                      00 |
|       17 | Meghlaya           |                                         01 |                                                                                      00 |
|       18 | Nagaland           |                                         01 |                                                                                      00 |
|       19 | Odisha             |                                         02 |                                                                                      04 |
|       20 | Puducherry         |                                         01 |                                                                                      00 |
|       21 | Punjab             |                                         01 |                                                                                      02 |
|       22 | Rajasthan          |                                         01 |                                                                                      10 |
|       23 | Sikkim             |                                         01 |                                                                                      00 |
|       24 | Tamilnadu          |                                         01 |                                                                                      12 |

|   25. | Telangana     |   02 |   01 |
|-------|---------------|------|------|
|    26 | Tripura       |   01 |   00 |
|    27 | Uttar Pradesh |   02 |   05 |
|    28 | Uttarakhand   |   01 |   05 |
|    29 | West Bengal   |   01 |   01 |
|    30 | Delhi         |   00 |   13 |

## Annexure-II

State/UT wise details of the total number of cases of substandard, misbranded and adulterated AYUSH drugs reported from rural areas in the last three financial years, State-wise and the punitive actions taken against the manufacturers and distributors of such drugs are as follows:

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|   S.No . | State   | Replies          | Replies                      | Replies                                                          | Replies                                                                             |
|----------|---------|------------------|------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------|
|        1 | Kerala  | Serial Numb er 1 | Name of substandard medicine | Name of manufacturer                                             | Details of legal action                                                             |
|        1 | Kerala  |                  | Mustharishtam AA 02/22       | M/S Valluwanad Ayurveda Oushadhasala, Keralassery                | Product suspended for one month                                                     |
|        1 | Kerala  | 2                | Hinguvachaadi Gulika XBGD    | M/S Nagarjuna Herbal Concentrates Ltd. Kalayanthanni, Thodupuzha | Departmental action- Suspension of production for 30 days                           |
|        1 | Kerala  | 3                | Mustharishtam                | M/S Sidda Herbal Products, Porathissery, Irinjalakkuda,Thris sur | Product suspended for one month                                                     |
|        1 | Kerala  | 5                | Amruthrotharam Kashayam      | Itoozhi vaidhyasala ,Mayyil,Kannur                               | Product suspended for one month                                                     |
|        1 | Kerala  | 6                | Dhanwantharam Kashayam       | Itoozhi vaidhyasala ,Mayyil,Kannur                               | Final complaint filed before the court on 4/10/2024                                 |
|        1 | Kerala  | 7                | Abhayarishtam                | M/s Bala Herbals, Industrial Estate, Karunagappally, Kollam      | Final Complaint Filed before Honourable JFM Court- Karunagappally Case No ST 585/23 |

|   8 | Dasamoolarishtam               | M/s PM Pharmacy Kollam                                  | Product suspended for one month                                |
|-----|--------------------------------|---------------------------------------------------------|----------------------------------------------------------------|
|   9 | Haridrakhandam                 | Chaithanya Ayurveda Pharmacy Vadakara,Kozhiko de        | Product suspended for one month                                |
|  10 | Gee Pee Choornam               | Sun Ayurvedic Medicines ,Ponnani,Malappur am            | Took departmental action                                       |
|  11 | Ashokarishtam Batch No 01/2025 | Jayalekshmi Pharma Mynagapally,Koll am                  | Sent showcause notice and stopped the sale of the product      |
|  12 | Dasamularishtam                | M/s Vaidyasala Veettil Oushadhasala, Elamadu PO, Kollam | Sent showcause notice and stopped the sale of the product      |
|  13 | Amrutharishtam                 | M/s Vaidyasala Veettil Oushadhasala, Elamadu PO, Kollam | Sent showcause notice and stopped the sale of the product      |
|  14 | Asokarishtam                   | Sakthi Ayruveda Pharmaceuticals, Thiruvananthapu ram    | Final complaint is being prepared for filing before the court. |
|  15 | Balarishtam                    | Sakthi Ayruveda Pharmaceuticals,                        | Final complaint is being prepared for                          |

|    |           |                  |                         | ram                                                                                                                 | Thiruvananthapu                                                                                                     | filing before the court.                                       |
|----|-----------|------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
|    |           | 16               |                         | Amrutharishtam                                                                                                      | Sakthi Ayruveda Pharmaceuticals, Thiruvananthapu ram                                                                | Final complaint is being prepared for filing before the court. |
| 2. | Jharkhand | Sl.              | Name of Product         | Manufacturer Action                                                                                                 | Manufacturer Action                                                                                                 |                                                                |
|    |           | 1.               | HELLO-Jiv               | M/s Yuvnam Private Limited, Gutuwa, Ranchi                                                                          | M/s Yuvnam Private Limited, Gutuwa, Ranchi                                                                          | Product approval cancelled                                     |
|    |           | 2.               | REPL Orthovit Capsule   | Renovision Export Pvt. Ltd UNIT-II Bhuyandih, Kamidih, P.O. Chilgu, PS:- Chandil, Dist: Saraikela- Kharsawan-832401 | Renovision Export Pvt. Ltd UNIT-II Bhuyandih, Kamidih, P.O. Chilgu, PS:- Chandil, Dist: Saraikela- Kharsawan-832401 | Case Filed                                                     |
|    |           | 3.               | Menstrual Pain Min 30ml | Bharti Pharma, C-39, Phase2, Industries Area, Adityapur-                                                            | Bharti Pharma, C-39, Phase2, Industries Area, Adityapur-                                                            | Product suspended for 60 days                                  |
|    |           | 4.               | Liv Drops 30ml          | Bharti Pharma, C-39, Phase2, Industries Area, Adityapur-                                                            | Bharti Pharma, C-39, Phase2, Industries Area, Adityapur-                                                            | Product suspended for 60 days                                  |
|    |           | 5.               | Urginia Tincture IP 66  | M/s Moxie Pharmaceuticals Pvt. Ltd., Shed No.- B 12 &13, Jasidih Industrial Area, Jasidih, Deoghar-                 | M/s Moxie Pharmaceuticals Pvt. Ltd., Shed No.- B 12 &13, Jasidih Industrial Area, Jasidih, Deoghar-                 | Product Cancel/Removed from approved products list             |
| 3. | Tripura   | Year wise report | Year wise report        | Misbranded Ayush medicines                                                                                          | Not of standard Ayush medicines                                                                                     | Not of standard Ayush medicines                                |
|    |           | 2022-2023        | 2022-2023               | 62                                                                                                                  | 03                                                                                                                  | 03                                                             |
|    |           | 2023-2024        | 2023-2024               | 07                                                                                                                  | -                                                                                                                   | -                                                              |
|    |           | 2024-2025        | 2024-2025               | 36                                                                                                                  | -                                                                                                                   | -                                                              |
|    |           | 2025-till date   | 2025-till date          | -                                                                                                                   | 01                                                                                                                  | 01                                                             |

| 4.   | Goa          |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                                                                          |
|------|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|      |              |                                                                                                                                                                      |                                                                                                                                                                      | Product Name                                                                                                                                                         | Product Name                                                                                                                                                         | Mfg by Action                                                                                                                                                                                                                                                                                            | Mfg by Action                                                                                                                                                                                                                                                                                            | Mfg by Action                                                                                                                                                                                                                                                                                            |
|      |              |                                                                                                                                                                      | 01 case of NSQ drug reporte d                                                                                                                                        | Avipattika r Churna (Tablets), B.N: HCT-21, M/D: 12/2021, E/D: M/s. Pharmaceutical s (P) F-67, Area, 302019 does conform                                             | Avipattika r Churna (Tablets), B.N: HCT-21, M/D: 12/2021, E/D: M/s. Pharmaceutical s (P) F-67, Area, 302019 does conform                                             | Karnani Ltd; Fact: Industrial Bhiwadi - suspended the manufacturing license of the firm M/s. Karnani Pharmaceuticals (P) Ltd for the period of six months. Showcause Notice was issued to Hospital Pharmacy, North Goa District Hospital, (Asilo Hospital), Mapusa Goa, from where the sample was drawn. | Karnani Ltd; Fact: Industrial Bhiwadi - suspended the manufacturing license of the firm M/s. Karnani Pharmaceuticals (P) Ltd for the period of six months. Showcause Notice was issued to Hospital Pharmacy, North Goa District Hospital, (Asilo Hospital), Mapusa Goa, from where the sample was drawn. | Karnani Ltd; Fact: Industrial Bhiwadi - suspended the manufacturing license of the firm M/s. Karnani Pharmaceuticals (P) Ltd for the period of six months. Showcause Notice was issued to Hospital Pharmacy, North Goa District Hospital, (Asilo Hospital), Mapusa Goa, from where the sample was drawn. |
| 5.   | Maharasht ra | The total number of cases of substandard, misbranded and adulterated AYUSH drugs reported from Maharashtra State in the last three financial years are as follows: - | The total number of cases of substandard, misbranded and adulterated AYUSH drugs reported from Maharashtra State in the last three financial years are as follows: - | The total number of cases of substandard, misbranded and adulterated AYUSH drugs reported from Maharashtra State in the last three financial years are as follows: - | The total number of cases of substandard, misbranded and adulterated AYUSH drugs reported from Maharashtra State in the last three financial years are as follows: - | The total number of cases of substandard, misbranded and adulterated AYUSH drugs reported from Maharashtra State in the last three financial years are as follows: -                                                                                                                                     | The total number of cases of substandard, misbranded and adulterated AYUSH drugs reported from Maharashtra State in the last three financial years are as follows: -                                                                                                                                     | The total number of cases of substandard, misbranded and adulterated AYUSH drugs reported from Maharashtra State in the last three financial years are as follows: -                                                                                                                                     |
|      |              |                                                                                                                                                                      | Period 01/04/2022 to 31/03/2023                                                                                                                                      | Period 01/04/2022 to 31/03/2023                                                                                                                                      | 01/04/202 3 to 31/03/202 4                                                                                                                                           | 01/04/20 24 to 31/03/20 25                                                                                                                                                                                                                                                                               |                                                                                                                                                                                                                                                                                                          | 01/04/2025 to 30/06/2025                                                                                                                                                                                                                                                                                 |
|      |              |                                                                                                                                                                      | Ayurvedi c Samples 834                                                                                                                                               | Ayurvedi c Samples 834                                                                                                                                               |                                                                                                                                                                      | 761                                                                                                                                                                                                                                                                                                      | 343                                                                                                                                                                                                                                                                                                      | 23                                                                                                                                                                                                                                                                                                       |
|      |              |                                                                                                                                                                      | Ayurvedi c Samples 526                                                                                                                                               | Ayurvedi c Samples 526                                                                                                                                               |                                                                                                                                                                      | 476                                                                                                                                                                                                                                                                                                      | 343                                                                                                                                                                                                                                                                                                      | 23                                                                                                                                                                                                                                                                                                       |
|      |              |                                                                                                                                                                      | No of samples declared 17                                                                                                                                            | No of samples declared 17                                                                                                                                            |                                                                                                                                                                      | 08                                                                                                                                                                                                                                                                                                       | 30                                                                                                                                                                                                                                                                                                       | 08                                                                                                                                                                                                                                                                                                       |
|      |              |                                                                                                                                                                      | No of consent for 14                                                                                                                                                 | No of consent for 14                                                                                                                                                 |                                                                                                                                                                      | 05                                                                                                                                                                                                                                                                                                       | 28                                                                                                                                                                                                                                                                                                       | 08                                                                                                                                                                                                                                                                                                       |
| 6.   | West Bengal  |                                                                                                                                                                      | S.No                                                                                                                                                                 | S.No                                                                                                                                                                 | Year                                                                                                                                                                 | Total number of cases of substandard, misbranded and adulterated AYUSH drugs                                                                                                                                                                                                                             | Total number of cases of substandard, misbranded and adulterated AYUSH drugs                                                                                                                                                                                                                             | Total number of cases of substandard, misbranded and adulterated AYUSH drugs                                                                                                                                                                                                                             |

|                       | 1 2                                                                                                                                                                                                                                                                | 2022                                                                                                                                                                                                                                                               | 11                                                                                                                                                                                                                                                                 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|                       |                                                                                                                                                                                                                                                                    | 2023                                                                                                                                                                                                                                                               | 13                                                                                                                                                                                                                                                                 |
|                       | 3                                                                                                                                                                                                                                                                  | 2024                                                                                                                                                                                                                                                               | 09                                                                                                                                                                                                                                                                 |
| 7. Odisha             | No cases of substandard, misbranded and adulterated AYUSH drugs reported from rural areas in the last three financial years in the State of Odisha.                                                                                                                | No cases of substandard, misbranded and adulterated AYUSH drugs reported from rural areas in the last three financial years in the State of Odisha.                                                                                                                | No cases of substandard, misbranded and adulterated AYUSH drugs reported from rural areas in the last three financial years in the State of Odisha.                                                                                                                |
| 8. Gujarat            | Total Number of Not of Standard Cases in the last three financial years is 45 &the State Licensing authority has taken final departmental action under the provisions of the Drugs and Cosmetics act, 1940 &Rules their under.                                     | Total Number of Not of Standard Cases in the last three financial years is 45 &the State Licensing authority has taken final departmental action under the provisions of the Drugs and Cosmetics act, 1940 &Rules their under.                                     | Total Number of Not of Standard Cases in the last three financial years is 45 &the State Licensing authority has taken final departmental action under the provisions of the Drugs and Cosmetics act, 1940 &Rules their under.                                     |
| 9. Uttarakhan d       | In the last two years total 123 Sample found substandard quality. The action is taken by the Drug Inspector as per Drug and Cosmetic Act 1940 Rules thereunder. And also, necessary action taken against the manufacturers/Companies by State Licensing Authority. | In the last two years total 123 Sample found substandard quality. The action is taken by the Drug Inspector as per Drug and Cosmetic Act 1940 Rules thereunder. And also, necessary action taken against the manufacturers/Companies by State Licensing Authority. | In the last two years total 123 Sample found substandard quality. The action is taken by the Drug Inspector as per Drug and Cosmetic Act 1940 Rules thereunder. And also, necessary action taken against the manufacturers/Companies by State Licensing Authority. |
| 10. Haryana           | Action has been taken as per Drugs and Cosmetics Act, 1940 and rules framed thereunder.                                                                                                                                                                            | Action has been taken as per Drugs and Cosmetics Act, 1940 and rules framed thereunder.                                                                                                                                                                            | Action has been taken as per Drugs and Cosmetics Act, 1940 and rules framed thereunder.                                                                                                                                                                            |
| 11.UT of Ladakh       | No cases reported in UT Ladakh.                                                                                                                                                                                                                                    | No cases reported in UT Ladakh.                                                                                                                                                                                                                                    | No cases reported in UT Ladakh.                                                                                                                                                                                                                                    |
| 12. Madhya Pradesh    | No such data collected.                                                                                                                                                                                                                                            | No such data collected.                                                                                                                                                                                                                                            | No such data collected.                                                                                                                                                                                                                                            |
| 13. Manipur           | No report as such.                                                                                                                                                                                                                                                 | No report as such.                                                                                                                                                                                                                                                 | No report as such.                                                                                                                                                                                                                                                 |
| 14. Puducherr y       | NIL                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                |
| 15. Delhi             | NIL                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                |
| 16. Arunachal Pradesh | NIL                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                |

## Annexure-III

The details of awareness programs have been conducted to strengthen pharmacovigilance of Ayush drugs throughout the nation under the pharmacovigilance program for ASU & H drugs for  practitioners,  healthcare  workers  and  other  different  cohort  including  general  public  to disseminate the awareness regarding patient safety are as follows: -

| Year                  |   Awareness Program | Beneficiaries   |
|-----------------------|---------------------|-----------------|
| 2018                  |                   1 | 50              |
| 2019                  |                  54 | 800             |
| 2020                  |                  60 | 4300            |
| 2021                  |                 118 | 14659           |
| 2022                  |                 292 | 23510           |
| 2023                  |                 586 | 43396           |
| 2024                  |                1065 | 105148          |
| 2025 (Upto June 2025) |                 692 | 66255           |
| Total                 |                2868 | 2,58,118        |