Lok Sabha Question No. 973 (UNSTARRED), answered on 2019-11-22
Subject: AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Dr. T. Sumathy (a) Thamizhachi Thangapandian

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

## LOK  SABHA UNSTARRED  QUESTION NO. 973 TO BE ANSWERED ON 22 ND NOVEMBER, 2019

## AYUSH MEDICINES

## 973. DR. T. SUMATHY (a) THAMIZHACHI THANGAPANDIAN:

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

- (a) whether the Government has taken any stringent measures to control and curb the sa spurious Ayurvedic and Unani medicines in the coun try;
- (b)  if  so,  the  details  thereof  and  the  list  of  cases  booked  against  the  sale  and  dis spurious medicines, State/ UT - wise and year - wise during the last five years;
- (c) whether the Government has chalked out any plans to provide adequate supply of AYUSH medicines and drugs in the country;
- (d) if so, the details thereof; and
- (e) the number of AYUSH clinics and hospitals in the country and the funds allocated duri last fi ve years for the same?

## ANSWER

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

(a) & (b): Provisions for regulation and quality control of Ayurvedic and Unani medicin being manufactured for sale in the country are prescribed in the  Drugs & Cosmetics 1940 & Rules 1945.  These provisions are enforced by the Licensing Authorities & Dr Control Officers appointed by the State Governments.  As the s purious Ayurvedic and Unani medicines are defined in Section 33 -I of the Drugs & Cosmetics Act, 1940 along with the penalty  provisions,    accordingly  the  defaulters    can  be  punished  with  monitory fine  and imprisonment for a term up to three years as determined by the court. State/ UT - wise and year - wise  details  of  the  cases  of  spurious,  adulterated  or  substandard  medicines  re during the last five years are given in the annexure.

(c) & (d): Ministry  of  AYUSH  has  published  Essential  Drug  Lists  of  Ayurveda,  Unani, Siddha and Homoeopathy medicines for ensuring supply of such medicines in the hospita and  dispensaries.  Through  the  Centrally  Sponsored  Scheme  of  National  AYUSH  Mission implemented since  2014,  grant - in - aid  is  provided  to  the  States/UTs  for  procurement  of AYUSH  medicines  and  for  strengthening  of  infrastructural  and  functional  capacity  of pharmacies.

(e): Country has 3986 hospitals, 27199 dispensaries and 15167 co - located centr es of AYUSH in the public sector.  Through the scheme of National AYUSH Mission grant - in - aid funds amounting to Rs.744.63 crore have been  provided to the States/UTs during the five years from 2014 - 15 to 2018 - 19.

year the

01

cancelled license

the

| Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last   | Annexure State/UT wise Numbe r of ASU&H medicine declared spurious/sub standard/adulterated during the last                               |
|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Sl. No.                                                                                                       | 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                                                                      |                                                                                                               |                                                                                                               | Action taken by the State Governments                                                                                                     |
|                                                                                                               |                                                                                                               | 2015-16                                                                                                       | 2015-16                                                                                                       | 2016-17                                                                                                       | 2016-17                                                                                                       | 2017-18                                                                                                       | 2017-18                                                                                                       | 2018-19                                                                                                       | 2018-19                                                                                                       | 2019-20                                                                                                       | 2019-20                                                                                                       |                                                                                                                                           |
|                                                                                                               |                                                                                                               | Tested                                                                                                        | Failed/ Sub Standa rd                                                                                         | Teste d                                                                                                       | Failed/Su b standard                                                                                          | Teste d                                                                                                       | Failed/Su b standard                                                                                          | Teste d                                                                                                       | Failed/Su b standard                                                                                          | Tested                                                                                                        | Failed/ Sub standard                                                                                          |                                                                                                                                           |
| 1                                                                                                             | Arunachal Pradesh                                                                                             | -                                                                                                             | -                                                                                                             | 91                                                                                                            | NA                                                                                                            | 145                                                                                                           | NA                                                                                                            | 80                                                                                                            | NA                                                                                                            | -                                                                                                             | -                                                                                                             | -                                                                                                                                         |
| 2                                                                                                             | Assam                                                                                                         | 319(A)                                                                                                        | 4                                                                                                             | 146(A )                                                                                                       | NIL                                                                                                           | 115(A )                                                                                                       | NIL                                                                                                           | 106(A )                                                                                                       | NIL                                                                                                           | 27                                                                                                            | -                                                                                                             | Show cause notices issued during 2015 - 16.                                                                                               |
| 3                                                                                                             | Bihar                                                                                                         | -                                                                                                             | -                                                                                                             | 15(A)                                                                                                         | -                                                                                                             | 02(A)                                                                                                         | -                                                                                                             | 01(A)                                                                                                         | -                                                                                                             | 02(A)                                                                                                         | -                                                                                                             | 05 cases lodged during the 2016- 17, 2018 - 19 & 2019- 20 respectively against manufacturers. license and 01 suspended in year 2019 - 20. |
| 4                                                                                                             | Chandigarh                                                                                                    | -                                                                                                             | -                                                                                                             | 715(A )+48( U)                                                                                                | -                                                                                                             | 423(A )+09( U)                                                                                                | -                                                                                                             | -                                                                                                             | -                                                                                                             | -                                                                                                             | -                                                                                                             | -                                                                                                                                         |
| 5                                                                                                             | Chhattisgarh                                                                                                  |                                                                                                               |                                                                                                               | 75(A)                                                                                                         | NIL                                                                                                           | 149(A                                                                                                         | 6                                                                                                             | 69(A)                                                                                                         | 1                                                                                                             | -                                                                                                             | -                                                                                                             | -                                                                                                                                         |

and of

for test/analysis  as  a

Quality of

21

and

|   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 market survey lifting Ayurvedic and Unani drugs samples test/analysis part of Control activity keep check spurious/sub - standard Ayurvedic and Unani medicines.   |
|-----|------------------|----------------------|---------------|---------------------|----------------|--------------------|-------------|---------------|----|-----|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   7 | Goa              | -                    | -             | 10                  | -              | 1                  | -           | 02            | -  | 10  | -   | No such cases sale and distribution spurious AYUSH medicines have been reported.                                                                                              |
|   8 | Gujarat          | 344 (ASU& H )        | 12            | 325 (ASU &H )       | NA             | 302 (ASU &H )      | 13          | 304 (ASU &H ) | 17 | 31  | -   | 12 spurious booked against manufacturers. Show cause notices issued firms and Licenses                                                                                        |
|   9 | Himachal Pradesh | -                    | -             | 748 (ASU)           | 53             | 577 (ASU)          | 61          | 94 (ASU)      | 4  | -   | -   | -                                                                                                                                                                             |
|  10 | Jharkhand        | -                    | -             | -                   | -              | 33(H)              | 3           | -             | -  | -   | -   | -                                                                                                                                                                             |
|  11 | J&K              | -                    | -             | -                   | -              | -                  | -           | -             | -  | -   | -   | 2 inspectors 12 Drug Control officers has notified in Dept. ISM                                                                                                               |

|   12 | Karnataka   | -            | -   | 1071( A)+87 (H)   | -   | 1026( A)+30 (H)   | -   | -          | -   | -       | -   | -                                                                                                                                                                                                                                                                                        |
|------|-------------|--------------|-----|-------------------|-----|-------------------|-----|------------|-----|---------|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   13 | Kerala      | 297(A)       | 7   | 297(A )           | 5   | 578               | 25  | 724        | 9   | 01      | -   | 07 cases have booked against Spurious/Failed Ayurveda Drugs                                                                                                                                                                                                                              |
|   14 | Maharashtra | -            | -   | 350               | -   | 320               | -   | -          | -   | -       | -   | -                                                                                                                                                                                                                                                                                        |
|   15 | Manipur     | NIL          | -   | NIL               | -   | Nil               | -   | NIL        | -   | -       | -   | -                                                                                                                                                                                                                                                                                        |
|   16 | Meghalaya   | 15(A), 10(H) | NIL | 15(A), 15(H)      | NIL | 11(A), 9(H)       | NIL | 5(A), 2(H) | NIL | -       | -   | -                                                                                                                                                                                                                                                                                        |
|   17 | Mizoram     | -            | -   | 31                | 11  | NIL               | -   | -          | -   | -       | -   | -                                                                                                                                                                                                                                                                                        |
|   18 | Nagaland    | -            | -   | NIL               | -   | NIL               | -   | -          | -   | -       | -   | -                                                                                                                                                                                                                                                                                        |
|   19 | Odisha      | 123 (A)      | -   | 638 (A)           | -   | 416 (A)           | -   | 451(A )    | -   | 138 (A) | -   | The suppliers Ayurvedic medicines insisted upon submit the reports of supplied from laboratory approved under Rule 160 A - J of the Drugs Cosmetics Rules 1945. Random inspection testing of supplied drugs also being out by the offici als authorized for purpose by State Government. |

of are

to the

batch and

and the

the to

of be

a

to of

drug been

|   20 | Puducherry   | -              | -            | -              | -           | -             | -     | -          | -     | -          | -   | Effective are taken control the sale Spurious Ayurvedic and Unani Medicine s.                                                                                                                                                                                                |
|------|--------------|----------------|--------------|----------------|-------------|---------------|-------|------------|-------|------------|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   21 | 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 drug samples found to Spurious/Substand ard were to take the batch out of market and re - test the samples from Drug Testing Laboratory marketing them. License of formulation of manufacturing has been and show cause notices issued 20 manufacturing units. |
|   22 | Tamilnadu    | 1509 (ASU)     | 60           | 1522 (ASU)     | 120         | 1821          | 74    | 2251 (ASU) | 92    | 2028 (ASU) | 15  | One formula manufacturing was cancelled. Drug Inspectors are appointed monthly target taking samples for testing has fixed.                                                                                                                                                  |

|   23 | Tripura     | 15(H)   | NIL   | 67 (ASU)   | NA   | 200 (ASU) , 1(H)   | NA   | 66 (ASU) , 132(H )   | NA   | -      | -   | Show cause notices issued 20 manufacturing units. No ayurvedic medicine has declared in last year.                       |
|------|-------------|---------|-------|------------|------|--------------------|------|----------------------|------|--------|-----|--------------------------------------------------------------------------------------------------------------------------|
|   24 | Uttarakhand | 111 (A) | 12    | 187 (A)    | NIL  | 250 (A)            | 53   | 199 (A)              | 6    | 67 (A) | 11  | In last 05 Drugs inspector the state taken samples and which 82 samples are not of quality. action against manufacturers |
|   25 | West Bengal | -       | -     | 8          | -    | 0                  | -    | -                    | -    | -      | -   | -                                                                                                                        |
|   26 | Lakshadweep |         | -     | -          | -    | -                  | -    | -                    | -    | -      | -   | No case of spurious having the booked the last five                                                                      |

to years

in taken

the

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