Lok Sabha Question No. 4550 (UNSTARRED), answered on 2020-03-20
Subject: AYUSH Education and Products
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: S.R. Parthiban

## GOVERNMENT OF INDIA MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH)

## LOK  SABHA UNSTARRED  QUESTION NO. 4550 TO BE ANSWERED ON  20 TH MARCH, 2020

## AYUSH EDUCATION AND PRODUCTS

## 4550. SHRI PARTHIBAN S.R.:

Will  the  Minister of AYURVEDA,  YOGA  AND  NATUROPATHY,  UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:

(a)  whether  the  Government  has  set  any  regulator/  regulatory  mechanism  to  supervise regulate AYUSH education and their products in the cou ntry;

- (b) if so, the details thereof; and
- (c) the number of companies found selling fake AYUSH products and the steps taken by Government to check counterfeit products in the market?

## ANSWER

## THE MI NISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (SHRI SHRIPAD YESSO NAIK)

(a) & (b) : Central Government has already established regulatory mechanisms to supervise an regulate AYUSH education and AYUSH products as under:

- (i) The Central Council of Indian Medicine a statutory body under the M/o AYUSH regulates education of Ayurved, Una ni, Siddha & Sowa - Rigpa systems in accordance with the provisions of the Indian Medicine Central Council Act, 1970 and regulations made thereunder. The Cen Council of Homoeopathy a statutory body under the M/o AYUSH regulates the education of Homeopath y in accordance with the provisions of the Homoeopathy Central Council Act, 197 and regulations made thereunder.

(ii) Central Government makes and amends the regulatory provisions in the Drugs & Cosmetic Act, 1940 and Rules there under for AYUSH drugs an d the enforcement of these provisions vests with the State Governments. Accordingly, Ministry of AYUSH in the Central Government has Drug  Control  Cell,  now  named  as  Drug  Policy  Section,  to  deal  with  regulatory  matters Ayurvedic,  Siddha,  Unani  and  Homo eopathy  drugs  and  to  coordinate  with  respective  State Licensing/Drug  Control  Authorities  in  this  regard.  Since  05.02.2018  a  vertical  struc AYUSH has been created within Central Drugs Standard Control Organization to oversee t regulation of Ayurved ic, Siddha, Unani and Homeopathy (ASU&H) drugs from central level. Nine regulatory posts including one post of Deputy Drugs Controller, four posts of Ass Drugs Controller (one each of Ayurveda, Siddha, Unani and Homoeopathy) and four posts Drug In spectors (one each of Ayurveda, Siddha, Unani and Homoeopathy) have been created and notified on 24.07.2019.

State/ UT - wise and year -wise details of the number of manufacturing companies against whom action taken for fake Ayurvedic/Siddha/Unani products r eported during the last four years are given in the annexure .

durin notices

Licens

|      |                   |                                          |                                          |                                          |                                          |                                          |                                          |                                          |                                          |                                                                                                                                                                         | Annexure                                                                                                                                                                |
|------|-------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| S.N. | Name of the State | Sample tested by Drug Testing Laboratory | Sample tested by Drug Testing Laboratory | Sample tested by Drug Testing Laboratory | Sample tested by Drug Testing Laboratory | Sample tested by Drug Testing Laboratory | Sample tested by Drug Testing Laboratory | Sample tested by Drug Testing Laboratory | Sample tested by Drug Testing Laboratory | fake Ayurvedic products. Action taken by the State Governments                                                                                                          | fake Ayurvedic products. Action taken by the State Governments                                                                                                          |
| S.N. | Name of the State | 2015-16                                  | 2015-16                                  | 2016-17                                  | 2016-17                                  | 2017-18                                  | 2017-18                                  | 2018-19                                  | 2018-19                                  |                                                                                                                                                                         |                                                                                                                                                                         |
| S.N. | Name of the State | Tested                                   | Failed/ Sub Standard                     | Tested                                   | Failed/ Sub standard                     | Tested                                   | Failed/ Sub standard                     | Tested                                   | Failed/ standard                         | Sub                                                                                                                                                                     |                                                                                                                                                                         |
| 1    | Arunachal Pradesh | -                                        | -                                        | 91                                       | NA                                       | 145                                      | NA                                       | 80                                       | NA                                       | -                                                                                                                                                                       | -                                                                                                                                                                       |
| 2    | Assam             | 319(A)                                   | 4                                        | 146(A)                                   | NIL                                      | 115(A)                                   | NIL                                      | 106(A)                                   | NIL                                      | Show cause notices 2015- 16.                                                                                                                                            | issued                                                                                                                                                                  |
| 3    | Bihar             | -                                        | -                                        | 15(A)                                    | -                                        | 02(A)                                    | -                                        | 01(A)                                    | -                                        | 05 cases lodged during the year - 17, 2018- 19 & 2019 - 20 respectively the manufacturers. 01 license and 01 license suspended in the 2019- 20.                         | 05 cases lodged during the year - 17, 2018- 19 & 2019 - 20 respectively the manufacturers. 01 license and 01 license suspended in the 2019- 20.                         |
| 4    | Chandigarh        | -                                        | -                                        | 715(A) +48(U)                            | -                                        | 423(A)                                   | -                                        | -                                        | -                                        | -                                                                                                                                                                       | -                                                                                                                                                                       |
| 5    | Chhattisgarh      |                                          |                                          | 75(A)                                    | NIL                                      | +09(U) 149(A)                            | 6                                        | 69(A)                                    | 1                                        | -                                                                                                                                                                       | -                                                                                                                                                                       |
| 6    | Delhi             | 3000(A), 1000 (U)                        | 13(A), 7(U)                              | 2048 (A), 100(U)                         | 11(A), 11(U)                             | 600(A) , 200(U)                          | 4(A),1(U)                                |                                          |                                          | Inspection and market survey and of Ayurvedic and Unani drugs for test/analysis as a part of Control activity to keep spurious/sub -standard Ayurvedic Unani medicines. | Inspection and market survey and of Ayurvedic and Unani drugs for test/analysis as a part of Control activity to keep spurious/sub -standard Ayurvedic Unani medicines. |
| 7    | Goa               | -                                        | -                                        | 10                                       | -                                        | 1                                        | -                                        | 02                                       | -                                        | No such cases of sale and distribution spurious AYUSH medicines have reported.                                                                                          | No such cases of sale and distribution spurious AYUSH medicines have reported.                                                                                          |
| 8    | Gujarat           | 344 (ASU&H)                              | 12                                       | 325 (ASU& H)                             | NA                                       | 302 (ASU& H)                             | 13                                       | 304 (ASU&H)                              | 17                                       | 12 spurious cases booked against manufacturers. Show cause issued to 8 firms and 21 suspended.                                                                          | 12 spurious cases booked against manufacturers. Show cause issued to 8 firms and 21 suspended.                                                                          |
| 9    | Himachal Pradesh  | -                                        | -                                        | 748 (ASU)                                | 53                                       | 577 (ASU)                                | 61                                       | 94 (ASU)                                 | 4                                        | 20 spurious cases booked against manufacturers.                                                                                                                         | 20 spurious cases booked against manufacturers.                                                                                                                         |
| 10   | Jharkhand         | -                                        | -                                        | -                                        | -                                        | 33(H)                                    | 3                                        | -                                        | -                                        | -                                                                                                                                                                       | -                                                                                                                                                                       |

agains agains

fr the

an case

|   11 | J&K            | -            | -   | -              | -   | -            | -   | -          | -   | 2 inspectors and 12 Drug Control has been notified in Dept. of ISM                                                                                                                                                                                                                                          |
|------|----------------|--------------|-----|----------------|-----|--------------|-----|------------|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   12 | Karnataka      | -            | -   | 1071(A) +87(H) | -   | 1026( A)+30( | -   | -          | -   | 08 spurious cases booked against manufacturers.                                                                                                                                                                                                                                                             |
|   13 | Kerala         | 297(A)       | 7   | 297(A)         | 5   | 578          | 25  | 724        | 9   | 09 cases have been booked Spurious/Failed Ayurveda Drugs.                                                                                                                                                                                                                                                   |
|   14 | Madhya Pradesh |              |     |                |     |              |     |            |     | 02 cases have been booked Spurious/Failed Ayurveda Drugs                                                                                                                                                                                                                                                    |
|   15 | Maharashtra    | -            | -   | 350            | -   | 320          | -   | -          | -   | -                                                                                                                                                                                                                                                                                                           |
|   16 | Manipur        | NIL          | -   | NIL            | -   | Nil          | -   | NIL        | -   | -                                                                                                                                                                                                                                                                                                           |
|   17 | Meghalaya      | 15(A), 10(H) | NIL | 15(A), 15(H)   | NIL | 11(A), 9(H)  | NIL | 5(A), 2(H) | NIL | -                                                                                                                                                                                                                                                                                                           |
|   18 | Mizoram        | -            | -   | 31             | 11  | NIL          | -   | -          | -   | -                                                                                                                                                                                                                                                                                                           |
|   19 | Nagaland       | -            | -   | NIL            | -   | NIL          | -   | -          | -   | -                                                                                                                                                                                                                                                                                                           |
|   20 | Odisha         | 123 (A)      | -   | 638 (A)        | -   | 416 (A)      | -   | 451(A)     | -   | The suppliers of Ayurvedic medicines are insisted upon to submit the reports of the supplied batch laboratory approved under Rule 160 - J of the Drugs and Cosmetics Rules Random inspection and testing of supplied drugs are also being by the offici als authorized for purpose by the State Government. |
|   21 | Puducherry     | -            | -   | -              | -   | -            | -   | -          | -   | Effective measures are taken to the sale of Spurious Ayurvedic Unani Medicines. 34 spurious booked against the manufacturers.                                                                                                                                                                               |

|   22 | Punjab      | 921(A), 12(U)   | 119(A), 3(U)   | 715(A), 48(U)   | 99(A), 2(U)   | 423(A) , 9(U)   | 55(A)   | 886(A)           | 69(A)   | Manufacturers of drug samples be Spurious/Substandard were take the whole batch out of the and re - test the samples from a Testing Laboratory before marketing them. License of a formulation manufacturing unit has been and show cause notices issued manufacturing units.   |
|------|-------------|-----------------|----------------|-----------------|---------------|-----------------|---------|------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   23 | Tamilnadu   | 1509 (ASU)      | 60             | 1522 (ASU)      | 120           | 1821            | 74      | 2251 (ASU)       | 92      | One formula of manufacturing unit cancelled. 23 Drug Inspectors appointed and monthly target of drug samples for quality testing fixed. 69 spurious cases booked the manufacturers.                                                                                             |
|   24 | Tripura     | 15(H)           | NIL            | 67 (ASU)        | NA            | 200 (ASU), 1(H) | NA      | 66 (ASU), 132(H) | NA      | Show cause notices issued to manufacturing units. No Ayurvedic medicine has been last 01 year.                                                                                                                                                                                  |
|   25 | Uttarakhand | 111 (A)         | 12             | 187 (A)         | NIL           | 250 (A)         | 53      | 199 (A)          | 6       | In last 05 years Drugs inspector state have taken 891 samples which 82 samples were not of quality. Necessary action taken the manufacturers                                                                                                                                    |
|   26 | West Bengal | -               | -              | 8               | -             | 0               | -       | -                | -       | -                                                                                                                                                                                                                                                                               |
|   27 | Lakshadweep |                 | -              | -               | -             | -               | -       | -                | -       | No case of spurious having the during the last five years                                                                                                                                                                                                                       |

Abbreviations used: A: Ayurvedic, S: Siddha, U: Unani, H: Homoeopathy, DTL: Drug Testing Laboratory, UT: Union Territory

a

2

spuriou