Lok Sabha Question No. 3794 (UNSTARRED), answered on 2023-08-11
Subject: Promotion of Quality AYUSH Drugs/Products
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Upendra Singh Rawat, Debasree Chaudhuri

## GOVERNMENTOFINDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 3794 TO BE ANSWERED ON 11AUGUST, 2023

## 'PROMOTION OF QUALITYAYUSH DRUGS/PRODUCTS'

## 3794 SHRI UPENDRASINGH RAWAT: MS. DEBASREE CHAUDHURI:

Will the Minister of AYUSH be pleased to state:

- (a) whether there is any law to check and control the quality of the AYUSH drugs and products, if so, the details thereof and if not, the reasons therefor;
- (b) whether the Government proposes to promote quality AYUSH drugs and products on a larger scale in the country, particularly in Uttar Pradesh;
- (c) if so, the challenges faced by the Government this regard, particularly in Uttar Pradesh;
- (d) the details of the number of samples of AYUSH drugs and products received, tested and failed during the last five years and the current year, State/UT-wise, year-wise and stream-wise;
- (e) whether any malpractices have been detected in manufacturing of AYUSH drugs and products and if so, the details thereof along with the steps taken to improve their quality; and
- (f) the funds allocated for testing of AYUSH drugs and products?

## ANSWER THE MINISTER OFAYUSH (SHRI SARBANANDASONOWAL)

- (a) The Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945 have exclusive regulatory provisions for Ayurvedic, Siddha, 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 and Cosmetics 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 and Cosmetics Rules, 1945 pertain to Homoeopathic drugs. It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing

units & medicines including proof of safety & effectiveness, compliance with the Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of Drugs and Cosmetics Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

- (b) and (c) Ministry of Ayush has implemented Central Sector Scheme AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) throughout the Country including for Uttar Pradesh. The total financial allocation to this scheme is Rs. 122.00 crores for five years. The components of 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 guideline is available at https://main.ayush.gov.in/schemes-2/central -sector-scheme/aogusy-scheme/

Further Ministry of Ayush encourages following certifications of AYUSH products as per details below:-

- Certification of Pharmaceutical Products (CoPP) as per WHO Guidelines for herbal products.
- Quality Certifications Scheme implemented by the Quality Council of India (QCI) for grant of AYUSH 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 international standards.

Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) is mandated to lays down the Pharmacopoeial Standards and Formulary specifications for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs, which serve as official compendia for ascertaining the Quality Control (identity, purity and strength) of the ASU&H drugs, included herein, as per Drugs & Cosmetics Act, 1940 and Rules 1945, thereunder.

(d) The details of the number of samples of AYUSH drugs and products received, tested and failed during the last five years and the current year, State/UT-wise, yearwise and stream-wise are attached at Annexure-I.

(e) 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 Homoeopathy drugs, is vested with the State Drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government. Further As per the information received from State/UT's Licensing Authorities, the details of malpractices detected in manufacturing of AYUSH Drugs and products are attached at Annexure- II.

(f) No funds have been allocated specifically for testing of AYUSH drugs and products. However Ministry of Ayush has implemented Central Sector Scheme AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) and the total financial allocation to this scheme is Rs. 122.00 crores for five years. One of the components of the Scheme is to Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards, under which Recurring expenditure covers:

1. Upto 10 Contractual Technical manpower.

2. Chemicals and Reagents.

3. AMC of equipments which are funded under the scheme.

*****

1. PCIM & H

Annexure- I

| Year           | System      |   Samples Collected |   Not tested due to less qty., Broken etc. |   Samples Tested |   Samples Failed |
|----------------|-------------|---------------------|--------------------------------------------|------------------|------------------|
| 2019-2020      | Homoeopathy |                 618 |                                         19 |              599 |               11 |
| 2019-2020      | Ayurveda    |                  37 |                                         01 |               36 |               09 |
| 2019-2020      | Siddha      |                  00 |                                         00 |               00 |               00 |
| 2019-2020      | Unani       |                  07 |                                         00 |               07 |               00 |
| 2020-21        | Homoeopathy |                 310 |                                         07 |              303 |               01 |
| 2020-21        | Ayurveda    |                  25 |                                         00 |               25 |               03 |
| 2020-21        | Siddha      |                  00 |                                         00 |               00 |               00 |
| 2020-21        | Unani       |                  00 |                                         00 |               00 |               00 |
| 2021-22        | Homoeopathy |                1027 |                                         21 |             1006 |               46 |
| 2021-22        | Ayurveda    |                  02 |                                         00 |               02 |               00 |
| 2021-22        | Siddha      |                  00 |                                         00 |               00 |               00 |
| 2021-22        | Unani       |                  00 |                                         00 |               00 |               00 |
| 2022-23        | Homoeopathy |                 249 |                                         06 |              243 |               06 |
| 2022-23        | Ayurveda    |                  28 |                                         03 |               25 |               21 |
| 2022-23        | Siddha      |                  00 |                                         00 |               00 |               00 |
| 2022-23        | Unani       |                  03 |                                         00 |               03 |               00 |
| 2023-till date | Homoeopathy |                  00 |                                         00 |               00 |               00 |
| 2023-till date | Ayurveda    |                  01 |                                         00 |               01 |               01 |
| 2023-till date | Siddha      |                  00 |                                         00 |               00 |               00 |
| 2023-till date | Unani       |                  00 |                                         00 |               00 |               00 |

| Sr. No.   | States/UTs   | Information   | Information       | Information    | Information    |
|-----------|--------------|---------------|-------------------|----------------|----------------|
| 1.        | Delhi        | Year          | Samples Collected | Samples Tested | Samples Failed |
|           |              | 2017-18       | 2372              | 2372           | 15             |

|    |           | 2018-19                            | 449                    | 449                  | 09                   |
|----|-----------|------------------------------------|------------------------|----------------------|----------------------|
|    |           | 2019-20                            | 1005                   | 1005                 | 15                   |
|    |           | 2020-21                            | 540                    | 540                  | 14                   |
|    |           | 2021-22                            | 433                    | 433                  | 14                   |
|    |           | 2022-23 (till date)                | 335                    | 335                  | 03                   |
| 2. | Karnataka | Year                               | Samples Received       | Samples Tested       | Samples Failed       |
|    |           | 2019-20                            | 976                    | 959                  | 57                   |
|    |           | 2020-21                            | 779                    | 742                  | 59                   |
|    |           | 2021-22                            | 852                    | 460                  | 00                   |
|    |           | 2022-23                            | 720                    | 348                  | 08                   |
|    |           | 2023-till date                     | 335                    | 97                   | 00                   |
| 3. | Kerala    | Year                               | Samples Collected      | Samples Tested       | Samples Failed       |
|    |           | 2018                               | 938                    | 938                  | 55                   |
|    |           | 2019                               | 719                    | 719                  | 28                   |
|    |           | 2020                               | 308                    | 308                  | 15                   |
|    |           | 2021                               | 391                    | 391                  | 13                   |
|    |           | 2022                               | 531                    | 531                  | 36                   |
|    |           | 2023 (data till the month of June) | 230                    | 230                  | 15                   |
| 4. | Odisha    | Year                               | Samples Received (A&H) | Samples Tested (A&H) | Samples Failed (A&H) |
|    |           | 2018-19                            | 542                    | 542                  | 102                  |
|    |           | 2019-20                            | 753                    | 753                  | 58                   |
|    |           | 2020-21                            | 2176                   | 2176                 | 844                  |
|    |           | 2021-22                            | 2073                   | 2073                 | 329                  |
|    |           | 2022-23                            | 1635                   | 1635                 | 304                  |
| 5. | Assam     | Year                               | Samples                | Samples              | Samples Failed       |

|    |           |                   |                 | Received          | Received          | Tested         | Tested         | Tested         |                |                |                |                |
|----|-----------|-------------------|-----------------|-------------------|-------------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|
|    |           | 2017-18           | 2017-18         | 101               | 101               | 111            | 111            | 111            | 00             | 00             | 00             | 00             |
|    |           | 2018-19           | 2018-19         | 174               | 174               | 161            | 161            | 161            | 00             | 00             | 00             | 00             |
|    |           | 2019-20           | 2019-20         | 92                | 92                | 74             | 74             | 74             | 01             | 01             | 01             | 01             |
|    |           | 2020-21           | 2020-21         | 230               | 230               | 115            | 115            | 115            | 27             | 27             | 27             | 27             |
|    |           | 2021-22           | 2021-22         | 117               | 117               | 175            | 175            | 175            | 14             | 14             | 14             | 14             |
|    |           | 2022-23           | 2022-23         | 64                | 64                | 137            | 137            | 137            | 02             | 02             | 02             | 02             |
|    |           | 2023-21/07/2023   | 2023-21/07/2023 | 152               | 152               | 64             | 64             | 64             | 17             | 17             | 17             | 17             |
| 6. | Tamilnadu | Year              | Samples Tested  | Samples Tested    | Samples Tested    | Samples Failed | Samples Failed | Samples Failed | Samples Failed | Samples Failed | Samples Failed | Samples Failed |
|    |           |                   | Ayurveda        | Unani             | Siddh a           | Ayurveda       | Ayurveda       | Unani          | Unani          | Unani          | Siddha         | Siddha         |
|    |           | 2018              | 388             | 31                | 685               | 23             | 23             | 00             | 00             | 00             | 27             | 27             |
|    |           | 2019              | 1264            | 152               | 2032              | 27             | 27             | 01             | 01             | 01             | 06             | 06             |
|    |           | 2020              | 675             | 41                | 1009              | 18             | 18             | 00             | 00             | 00             | 05             | 05             |
|    |           | 2021              | 533             | 37                | 1176              | 26             | 26             | 00             | 00             | 00             | 05             | 05             |
|    |           | 2022              | 1100            | 91                | 1539              | 15             | 15             | 01             | 01             | 01             | 05             | 05             |
|    |           | 2023 (Up to july) | 495             | 41                | 845               | 01             | 01             | 00             | 00             | 00             | 01             | 01             |
| 7. | Manipur   | Year              | Year            | Samples Collected | Samples Collected | Samples Tested | Samples Tested | Samples Tested | Samples Failed | Samples Failed | Samples Failed | Samples Failed |
|    |           |                   | A.              |                   | H.                | A.             | U.             | H.             | A.             | U.             |                | H.             |
|    |           | 2019              | 07              |                   | 35                | 07             | 01             | 35             | 00             |                | 00             | 01             |
|    |           | 2020              | 00              |                   | 16                | 00             | 00             | 16             | 00             |                | 00             | 01             |
|    |           | 2021              | 07              |                   | 00                | 07             | 03             | 00             |                | 00             | 00             | 00             |
|    |           | 2022-23           | 00              |                   | 00                | 00             | 00             | 00             | 00             |                | 00             | 00             |
| 8. | Rajasthan | Year              |                 | Samples Collected | Samples Collected | Samples        | Samples        | Samples        | Samples        | Samples        | Samples        | Samples        |
|    |           | 2019-20           |                 |                   |                   | Tested         | Tested         | Tested         | Failed         | Failed         | Failed         | Failed         |
|    |           |                   | 193             |                   |                   | 181            | 181            | 181            | 36             | 36             | 36             | 36             |
|    |           | 2020-21           | 736             |                   |                   | 537            | 537            | 537            |                |                |                |                |
|    |           | 2021-22           |                 |                   |                   |                | 639            |                | 99 84          | 99 84          | 99 84          | 99 84          |

|     |             | 2022-23                                                                            | 581                                                                                | 549                                                                                | 39                                                                                 |
|-----|-------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
|     |             | 2023-till date                                                                     | 146                                                                                | 145                                                                                | 22                                                                                 |
| 9.  | Goa         | Year                                                                               | Samples Collected                                                                  | Samples Tested                                                                     | Samples Failed                                                                     |
|     |             | 2018-19                                                                            | 01                                                                                 | 01                                                                                 | NIL                                                                                |
|     |             | 2019-20                                                                            | 29                                                                                 | 07                                                                                 | NIL                                                                                |
|     |             | 2020-21                                                                            | 58                                                                                 | 29                                                                                 | NIL                                                                                |
|     |             | 2021-22                                                                            | 70                                                                                 | 75*                                                                                | NIL                                                                                |
|     |             | 2022-23                                                                            | 202                                                                                | 227*                                                                               | 01                                                                                 |
|     |             | 04/2023-07/2023                                                                    | 30                                                                                 | 47*                                                                                | 01                                                                                 |
|     |             | (*-Extra samples analysed are the samples carried forward from the previous years) | (*-Extra samples analysed are the samples carried forward from the previous years) | (*-Extra samples analysed are the samples carried forward from the previous years) | (*-Extra samples analysed are the samples carried forward from the previous years) |
| 10. | Gujarat     | Year                                                                               | Samples Tested                                                                     | Samples Failed                                                                     | Samples Failed                                                                     |
|     |             | 2018-19                                                                            | 304                                                                                | 17                                                                                 | 17                                                                                 |
|     |             | 2019-20                                                                            | 97                                                                                 | 00                                                                                 | 00                                                                                 |
|     |             | 2020-21                                                                            | 408                                                                                | 70                                                                                 | 70                                                                                 |
|     |             | 2021-22                                                                            | 71                                                                                 | 12                                                                                 | 12                                                                                 |
|     |             | 2022-23                                                                            | 172                                                                                | 12                                                                                 | 12                                                                                 |
| 11. | Haryana     | Year                                                                               | Samples Tested                                                                     | Samples Failed                                                                     | Samples Failed                                                                     |
|     |             | 2018-19                                                                            | 240                                                                                | 11                                                                                 | 11                                                                                 |
|     |             | 2019-20                                                                            | 799                                                                                | 42                                                                                 | 42                                                                                 |
|     |             | 2020-21                                                                            | 1038                                                                               | 54                                                                                 | 54                                                                                 |
|     |             | 2021-22                                                                            | 600                                                                                | 43                                                                                 | 43                                                                                 |
|     |             | 2022-23                                                                            | 1133                                                                               | 59                                                                                 | 59                                                                                 |
| 12. | Uttarakhand | Year                                                                               | Samples Tested                                                                     | Samples Failed                                                                     | Samples Failed                                                                     |
|     |             | 2018-19                                                                            | 199                                                                                | 06                                                                                 | 06                                                                                 |
|     |             | 2019-20                                                                            | 74                                                                                 | 08                                                                                 | 08                                                                                 |
|     |             | 2020-21                                                                            | 114                                                                                | 09                                                                                 | 09                                                                                 |
|     |             | 2021-22                                                                            | 55                                                                                 | 15                                                                                 | 15                                                                                 |

|     |                  | 2022-23        | 116                       | 16                        |
|-----|------------------|----------------|---------------------------|---------------------------|
|     |                  | 2023-till date | 32                        | 01                        |
| 13. | Mizoram          | Year           | Samples Tested            | Samples Failed            |
|     |                  | 2019-june 2023 | 1574                      | 38                        |
| 14. | Himachal Pradesh | Year           | Samples Tested            | Samples Failed            |
|     |                  | 2018-19        | 385                       | 23                        |
|     |                  | 2019-20        | 462                       | 50                        |
|     |                  | 2020-21        | 404                       | 27                        |
|     |                  | 2021-22        | 443                       | 31                        |
|     |                  | 2022-23        | 816                       | 53                        |
| 15. | Andhra           | Year           | Products Received, tested | Products Received, tested |
|     | Pradesh          | 2018-19        | 108                       | 108                       |
|     |                  | 2019-20        | 16                        | 16                        |
|     |                  | 2020-21        | 176                       | 176                       |
|     |                  | 2021-22        | 17                        | 17                        |
|     |                  | 2022-23        | 07                        | 07                        |
| 16. | West             | Year           | Products Received, tested | Products Received, tested |
|     | Bengal           | 2017-22        | NIL                       | NIL                       |
|     |                  | 2022-23        | 08                        | 08                        |
| 17. | Chandigarh       | Year           | Sample Collected          | Sample Collected          |
|     |                  | 2022           | 01                        | 01                        |

## Annexure- II

|   Sr. No. | States/UTs     | Malpractices detected                                                                                                    | Malpractices detected                                                                                                    | Malpractices detected                                                                                                    | Malpractices detected                                                                                                    |
|-----------|----------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
|         1 | Andhra Pradesh | NIL                                                                                                                      | NIL                                                                                                                      | NIL                                                                                                                      | NIL                                                                                                                      |
|         2 | Delhi          | NIL                                                                                                                      | NIL                                                                                                                      | NIL                                                                                                                      | NIL                                                                                                                      |
|         3 | Gujarat        | Year                                                                                                                     | Product                                                                                                                  | Reason                                                                                                                   | Action Taken                                                                                                             |
|         3 | Gujarat        | 2019                                                                                                                     | Without Licence Ayurvedic Product Manufactured-V inubhai Kantibhai Patel Gandhinagar                                     | Without Licence Ayurvedic Medicine Manufactured                                                                          | Court Case Launched                                                                                                      |
|         3 | Gujarat        | 2020                                                                                                                     | Krish Hand Sanitizer Gel                                                                                                 | The Does Not Show Presence Of Isopropyl, Alcohol& The Sample Shows Presence Of Methanol                                  | Product Permission Cancelled                                                                                             |
|         3 | Gujarat        |                                                                                                                          | Collage G7 Hand Sanitizer                                                                                                | Nil                                                                                                                      | Product Permission Cancelled                                                                                             |
|         3 | Gujarat        |                                                                                                                          | 2021 NIL                                                                                                                 | 2021 NIL                                                                                                                 | 2021 NIL                                                                                                                 |
|         3 | Gujarat        | 2022                                                                                                                     | Relaxo Mood Support 500 Ml                                                                                               | Herbal Sample Contains 20.27% Ethyl Alcohol                                                                              | Investigation is going on.                                                                                               |
|         3 | Gujarat        |                                                                                                                          | Relaxo Mood Support 250 Ml                                                                                               | Herbal Sample Contains 22.34% Ethyl Alcohol                                                                              | Investigation is going on.                                                                                               |
|         3 | Gujarat        |                                                                                                                          | Tulsi Santra- Ashva Herbal Tonic                                                                                         | The Sample Contains 13.38 percent V/V Ethyl Alcohol.                                                                     | Investigation is going on.                                                                                               |
|         3 | Gujarat        | 2023                                                                                                                     | NIL                                                                                                                      | NIL                                                                                                                      | NIL                                                                                                                      |
|         4 | Kerala         | The drugs that were tested Not of Standard Quality were subjected to departmental action and in serious offences such as | The drugs that were tested Not of Standard Quality were subjected to departmental action and in serious offences such as | The drugs that were tested Not of Standard Quality were subjected to departmental action and in serious offences such as | The drugs that were tested Not of Standard Quality were subjected to departmental action and in serious offences such as |

|    |                  | detection of allopathic drugs prosecution was initiated.                                     |
|----|------------------|----------------------------------------------------------------------------------------------|
|  5 | Rajasthan        | Action is taken as per rules against the producer firm, when the samples found Sub-standard. |
|  6 | Goa              | NIL                                                                                          |
|  7 | Haryana          | -                                                                                            |
|  8 | Karnataka        | NIL                                                                                          |
|  9 | Mizoram          | NIL                                                                                          |
| 10 | Odisha           | NIL                                                                                          |
| 11 | Puducherry       | NIL                                                                                          |
| 12 | Tamilnadu        | -                                                                                            |
| 13 | Uttarakhand      | NIL                                                                                          |
| 14 | West Bengal      | NIL                                                                                          |
| 15 | Himachal Pradesh | NIL                                                                                          |
| 16 | Chandigarh       | NIL                                                                                          |

*****