Lok Sabha Question No. 905 (UNSTARRED), answered on 2018-12-14
Subject: Spurious AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: RAJESHBHAI NARANBHAI CHUDASAMA, GOWDAR MALLIKARJUNAPPA SIDDESHWARA

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

## LOK  SABHA UNSTARRED  QUESTION NO. 905 TO BE ANSWERED ON 14 TH DECEMBER, 2018

## SPURIOUS AYUSH MEDIC INES

## 905. SHRI RAJESHBHAI CHUDASAMA:

## SHRI G.M. SIDDESHWARA:

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

- (a) whether the Union Government has taken any stringent measures to control and curb the of spurious Ayurvedic an d Unani medicines in the country;
- (b) if so, the details thereof and the list of cases registered against the sale and d spurious AYUSH medicines, State - wise during the last four years;
- (c)  whether  Government  has  chalked  out  any  plans  to  provide  adequate  supply  of  AYUSH medicines and drugs in the country; and
- (d) if so, the details thereof?

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

- (a)& (b): Regulatory provisions for Spurious Ayurvedic and Unani medicines are prescribed Drugs & Cosmetics Act, 1940. The penalty provisions are also prescribed in Section 33 -I of the Act for the defaulter to be punished with monetary fine and imprisonment for a term up to thr determined by the court. The responsibility to enforce these provisions is vested with t State  Governments.    State - wise  statement  of  reported  cases  of  spurious  or  substandard  AYU medicines is provided in the Annexure.
- (c ) & (d): Since September, 2014 Government has implemented a Centrally Sponsored Schem National  AYUSH  Mission  through  which  grant - in - aid  from  Rs 1.00  lakh  to  Rs  2.00  lakh  per dispensary/hospital per annum is provided for supply of essential AYUSH medicines to the approval  of  the  State  Annual  Action  Plans.  States  are  required  to  procure  these  med accordance with the Essential Dru gs Lists published by the Central Government and at least 50% the grant funds have to be utilized for procurement of medicines from Central or State Pu Undertakings/Cooperative pharmacies.

| ANNEXURE wise Number of ASU&Hmedicine reported as spurious/sub standard   | ANNEXURE wise Number of ASU&Hmedicine reported as spurious/sub standard   | ANNEXURE wise Number of ASU&Hmedicine reported as spurious/sub standard   | ANNEXURE wise Number of ASU&Hmedicine reported as spurious/sub standard   | ANNEXURE wise Number of ASU&Hmedicine reported as spurious/sub standard   | ANNEXURE wise Number of ASU&Hmedicine reported as spurious/sub standard   | ANNEXURE wise Number of ASU&Hmedicine reported as spurious/sub standard   | ANNEXURE wise Number of ASU&Hmedicine reported as spurious/sub standard   | ANNEXURE wise Number of ASU&Hmedicine reported as spurious/sub standard   | ANNEXURE wise Number of ASU&Hmedicine reported as spurious/sub standard                                                                                                                                      |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sl.                                                                       | Name of the                                                               | 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                                  | Action taken by the State Governments                                                                                                                                                                        |
| No.                                                                       | State                                                                     | 2015-16                                                                   | 2015-16                                                                   | 2016-17                                                                   | 2016-17                                                                   | 2018-19                                                                   | 2018-19                                                                   |                                                                           |                                                                                                                                                                                                              |
|                                                                           |                                                                           | Tested                                                                    | Failed/ Sub Standa rd                                                     | Tested                                                                    | Failed/Sub standard                                                       | Failed/ Sub standard                                                      | Tested                                                                    | Failed/Sub standard                                                       |                                                                                                                                                                                                              |
| 1                                                                         | Arunachal Pradesh                                                         | -                                                                         | -                                                                         | 91                                                                        | NA                                                                        | NA                                                                        | 80                                                                        | NA                                                                        | -                                                                                                                                                                                                            |
| 2                                                                         | Assam                                                                     | 319(A)                                                                    | 4                                                                         | 146(A)                                                                    | NIL                                                                       | NIL                                                                       | 106(A)                                                                    | NIL                                                                       | Show cause notices issued during 2015-16.                                                                                                                                                                    |
| 3                                                                         | Chandigarh                                                                | -                                                                         | -                                                                         | 715(A)+48( U)                                                             | -                                                                         | -                                                                         | -                                                                         | -                                                                         | -                                                                                                                                                                                                            |
| 4                                                                         | Chhattisgarh                                                              |                                                                           |                                                                           | 75(A)                                                                     | NIL                                                                       | 6                                                                         | 69(A)                                                                     | 1                                                                         |                                                                                                                                                                                                              |
| 5                                                                         | Delhi                                                                     | 3000(A), 1000 (U)                                                         | 13(A), 7(U)                                                               | 2048 (A), 100(U)                                                          | 11(A), 11(U)                                                              | 4(A),1(U )                                                                |                                                                           |                                                                           | Inspection and market survey and lifting of Ayurvedic and Unani drugs samples for test/analysis as a part of Quality Control activity to keep check on spurious/sub- standard Ayurvedic and Unani medicines. |
| 6                                                                         | Goa                                                                       | -                                                                         | -                                                                         | 10                                                                        | -                                                                         | -                                                                         | NIL                                                                       | -                                                                         | -                                                                                                                                                                                                            |
| 7                                                                         | Gujarat                                                                   | 322(A), 5(H)                                                              | 10                                                                        | 267 (ASU), 58(H)                                                          | NA                                                                        | NA                                                                        | 110 (ASU)                                                                 | NA                                                                        | Show cause notices issued to 8 firms and 21 Licenses suspended.                                                                                                                                              |
| 8                                                                         | Himachal Pradesh                                                          | -                                                                         | -                                                                         | 748 (ASU)                                                                 | 53                                                                        | 61                                                                        | 94 (ASU)                                                                  | 4                                                                         | -                                                                                                                                                                                                            |
| 9                                                                         | Jharkhand                                                                 | -                                                                         | -                                                                         | -                                                                         | -                                                                         | 3                                                                         | -                                                                         | -                                                                         | -                                                                                                                                                                                                            |
| 10                                                                        | Karnataka                                                                 | -                                                                         | -                                                                         | 1071(A),87( H)                                                            | -                                                                         | -                                                                         | -                                                                         | -                                                                         | -                                                                                                                                                                                                            |
| 11                                                                        | Kerala                                                                    | 297(A)                                                                    | 7                                                                         | 297(A)                                                                    | 5                                                                         | 25                                                                        | 724                                                                       | 9                                                                         | Four cases have been booked against Spurious/Failed Ayurveda Drugs                                                                                                                                           |

|   12 | Maharashtra   | -             | -            | 350           | -           | 320           | -     | -          | -     | -                                                                                                                                                                                                                                                                                                                                                 |
|------|---------------|---------------|--------------|---------------|-------------|---------------|-------|------------|-------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   13 | Manipur       | NIL           | -            | NIL           | -           | Nil           | -     | NIL        | -     | -                                                                                                                                                                                                                                                                                                                                                 |
|   14 | Meghalaya     | 15(A), 10(H)  | NIL          | 15(A), 15(H)  | NIL         | 11(A), 9(H)   | NIL   | 5(A), 2(H) | NIL   | -                                                                                                                                                                                                                                                                                                                                                 |
|   15 | Mizoram       | -             | -            | 31            | 11          | NIL           | -     | -          | -     | -                                                                                                                                                                                                                                                                                                                                                 |
|   16 | Nagaland      | -             | -            | NIL           | -           | NIL           | -     | -          | -     | -                                                                                                                                                                                                                                                                                                                                                 |
|   17 | Odisha        | -             | -            | 45            | -           | 53            | -     | -          | -     | The suppliers of Ayurvedic medicines are insisted upon to submit the testing reports of the supplied batch from laboratory approved under Rule 160 A-J of the Drugs and Cosmetics Rules 1945. Random inspection and testing of the supplied drugs are also being carried out by the officials authorized for the purpose by the State Government. |
|   18 | Puducherry    | -             | -            | -             | -           | -             | -     | -          | -     | Effective measures are taken to control the sale of Spurious Ayurvedic and Unani Medicine.                                                                                                                                                                                                                                                        |
|   19 | 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 found to be Spurious/Substatnderd were directed to take the whole batch out of the market and re-test the samples from a Drug Testing Laboratory before marketing them. License of a formulation of one manufacturing unit has been cancelled and show cause notices issued to 20 manufacturing units.              |

|   20 | Tamilnadu   | -         | -   | 1809(ASU)   | 128   | 1821            | 74   | 537              | 33   | One formula of manufacturing unit was cancelled. 23 Drug Inspectors are appointed and monthly target of taking drug samples for quality testing has been fixed.   |
|------|-------------|-----------|-----|-------------|-------|-----------------|------|------------------|------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   21 | Tripura     | 15(H)     | NIL | 67 (ASU)    | NA    | 200 (ASU), 1(H) | NA   | 66 (ASU), 132(H) | NA   | Show cause notices issued to 20 manufacturing units.                                                                                                              |
|   22 | Uttarakhand | 111 (ASU) | 12  | 187 (ASU)   | NIL   | 250 (ASU)       | 53   | 27 (ASU)         | 3    | -                                                                                                                                                                 |
|   23 | West Bengal | -         | -   | 8           | -     | 0               | -    | -                | -    | -                                                                                                                                                                 |

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