Lok Sabha Question No. 154 (UNSTARRED), answered on 2017-12-15
Subject: Supply of Spurious AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: V. SATHYABAMA, RITI PATHAK, KRISHNAN NARAYANASAMY RAMACHANDRAN, PR. SENTHILNATHAN, R.K. BHARATHI MOHAN

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

## LOK  SABHA UNSTARRED  QUESTION NO. 154 TO BE ANSWERED ON 15 TH DECEMBER, 2017

## SUPP LY OF SPURIOUS AYUSH MEDICINES

## 154. SHRIMATI V. SATHYA BAMA:

SHRIMATI RITI PATHAK:

SHRI K.N. RAMACHANDRAN:

SHRI PR. SENTHIL NATHAN:

SHRI BHARATHI MOHAN R.K.:

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

- (a) the details of AYUSH clinics and hospitals running at present in the country, State/UT -wise;
- (b) whether the Government has received information regarding the supply of spurious AYU medicines and if so, the details thereof;
- (c) whether the Government ha s t ken any stringent measures to control and curb the sale of su medicines in the country;
- (d)  if  so  the,  details  thereof  and  the  list  of  cases  booked  against  the  sale  and  dis spurious medicines during each of the last three years, State/U T-wise; and
- (e)  whether  the  Government  has  chalked  out  any  plans  to  provide  adequate  supply  of  g quality AYUSH medicines and drugs in the country and 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): The  States/UTs  wise  number  of  AYUSH  hospitals/dispensaries  is  furnished  at Annexure - I.
- (b) : Information received from some States/UTs regarding the number of ASU&H medicines tested  and  declared  spurious/  sub - standard/adulterated  during  the  last  three  years  is  placed Annexure - II .

Contd…….

( c) & (d) : The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules,1945 have provisions  for  the  regulation  and  quality  control  of  Ayurvedic  and  Unani  medicines  i country, which are enforced by the State Governments.  It is mandatory for the manufact urers to adhere  to  the  prescribed  requirements  for  licensing  of  manufacturing  units  &  medic including proof of safety & effectiveness and comply to Good Manufacturing Practices (GMP) and  quality  standards  of  drugs  given  in  the  pharmacopoeia.  Spurious, Adulterated  and Misbranded medicines a nd the penal provisions thereto are defined in the Act. Accordingly, the Licensing Authorities/Drugs Controllers appointed by the State Governments are empowered take necessary action against the defaulters acting i n contravention of the legal provisions.

Following steps have been taken by the Government for effective quality control of AYU medicines:

- 1) Rule 158 - B in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines issue of license to manufacture Ayurvedic and Unani medicines in accordance with the pro safety and effectiveness.
- 2) Display of shelf - life for expiry date on the l abel of medicines has been made mandatory under the provisions of Drugs and Cosmetic Rules, 1945.
- 3) Scheduled list of potentially hazardous substances of Ayurvedic and Unani systems is no under the provisions of Drugs and Cosmetics Rules, 1945. It is mandatory for the manufacturer to label the container with the words 'Caution: To be taken under medical supervision' both in English and Hindi languages for the formulations containing such ingredients.
- 4) 27  State  Drug  Testing  Laboratories  and  47  State  Ph armacies  have  been  supported  for strengthening  their  infrastructural  and  functional  capacity.    As  on  date  5 5 laboratories  are approved  or  licensed  under  the  provisions  of  Drugs  and  Cosmetics  Rules,  1945  for  qua testing of Ayurvedic, Siddha and Unani dr ugs and raw materials.
- 5) In order to promote safe use of AYUSH medicines, the Ministry of AYUSH has signed a MoU  with  the  Advertising  Standards  Council  of  India  (ASCI)  to  undertake  monitoring misleading advertisements appearing in the print and TV media and bring the defaulters to the notice of the Central Government and the State Regulators for taking necessary action.
- 6) The Medical Store In -charges of respective systems of medicine and Medicines Inspection Committee  (MIC)  randomly  check  the  medicines  su pplied  under  Central  Government  Health Scheme.  If  the  store  receives  any  complaint  in  respect  of  any  medicine,  the  supply  o medicine  is  stopped  immediately  and  process  of  withdrawal  of  the  issued  medicine  f dispensary or hospital is started.  Samp les of medicines are sent for testing to Central Laborator or NABL accredited /Government approved laboratory.

Contd………

7) Powers are vested with the Central Government under Section 33P of the Drugs & Cosmetics Act, 1940 to give directions to the State Governments as and when required for enforceme the legal provisions related to Ayurvedic, Siddha and Unani drugs.

8) Central  Government  issued  orders  to  procurement  agencies  of  ASU&H  Drugs  to  obtain batch - wise  testing  reports  of  the  medicines  be ing procured  and  supplied  to  hospitals  & dispensaries. States - wise information of testing of drugs and action taken for Spurious/adult Drugs is provided in Annexure - II.

(e) : In order to provide Good Q uality AYUSH medicines the Government is providing Grant -in - aid  to  the  States  and  UTs  under  National AYUSH Mission (NAM) for augmenting quality control  of  these  drugs,  including  strengthening  of  Pharmacies,  Drug  Testing  Laborato enforcement framework and testing of drugs.

Further,  under  the  Centrally  Sponsored  Scheme  of  National  AYUSH  Mission  (NAM)  for providing  adequate  supply  of  good  quality  AYUSH  medicines and  drug s  in  the  country, following provision has been made:

- a) Essential drugs and medicines re quired for implementation of the Mission will have to be  procured  from  Essential  Drugs  List  (EDL)  for  Ayurveda,  Unani,  Siddha  and Homoeopathy published by Department of AYUSH, Government of India.
- b) At least 50% of the Grant - in aid provided for procurement o f medicines should be used for  procuring  medicines  from  M/s  Indian  Medicine  Pharmaceutical  Corporation Limited  (a  Central  Public  Sector  Undertaking)  or  from  Public  Sector  undertakin pharmacies  under  State  Governments  and  Co - operatives  manufactured  in  th eir  own manufacturing  units  and  having  Good  Manufacturing  Practices  (GMP)  compliance, keeping in view the need for ensuring quality of AYUSH drugs and medicines.
- c) The remaining Grant - in aid provided under the Mission for purchase of medicines may be used f or procuring medicines as per Essential Drugs List (EDL) of Ayurveda, Unani Siddha and Homoeopathy published by Department of AYUSH, Government of India, from  other  Good  Manufacturing  Practices  (GMP)  compliant  units  having  valid manufacturing licenses.
- d) Essential non drug items like dressing items for first aid etc. may be provided the  amount  sanctioned  for  medicine/  essential  drugs  under  different  componen required for achieving the desired objectives subject to a ceiling of five percen t otal amount sanctioned for the purpose.

………….

State/UT wise/System wise Number of AYUSH Hospitals as on 1 -4- 2016

| S. No   | State / UT        |   Ayurved a |   Unani |   Siddha |   Yog a |   Naturo -pathy |   Homoeopat hy |   Sowa - Rigpa |   Total |
|---------|-------------------|-------------|---------|----------|---------|-----------------|----------------|----------------|---------|
| 1       | Andhra Pradesh    |           3 |       2 |        0 |       0 |               0 |              3 |              0 |       8 |
| 2       | Arunachal Pradesh |          10 |       0 |        0 |       0 |               0 |              2 |              0 |      12 |
| 3       | Assam             |           1 |       0 |        0 |       0 |               0 |              3 |              0 |       4 |
| 4       | Bihar             |           5 |       1 |        0 |       0 |               0 |              2 |              0 |       8 |
| 5       | Chhattisgarh      |           9 |       1 |        0 |       1 |               0 |              3 |              0 |      14 |
| 6       | Delhi             |           2 |       1 |        0 |       0 |               0 |              2 |              0 |       5 |
| 7       | Goa               |           0 |       0 |        0 |       0 |               0 |              0 |              0 |       0 |
| 8       | Gujarat           |          42 |       0 |        0 |       0 |               6 |             16 |              0 |      64 |
| 9       | Haryana           |           9 |       1 |        0 |       0 |               0 |              1 |              0 |      11 |
| 10      | Himachal Pradesh  |          31 |       0 |        0 |       0 |               1 |              0 |              0 |      32 |
| 11      | Jammu & Kashmir   |           1 |       1 |        0 |       0 |               0 |              0 |              0 |       2 |
| 12      | Jharkhand         |           1 |       0 |        0 |       0 |               0 |              4 |              0 |       5 |
| 13      | Karnataka         |         170 |      18 |        0 |       3 |               6 |             16 |              0 |     213 |
| 14      | Kerala            |         124 |       0 |        1 |       0 |               1 |             31 |              0 |     157 |
| 15      | Madhya Pradesh    |          21 |       0 |        0 |       0 |               0 |              2 |              0 |      23 |
| 16      | Maharashtra       |          63 |       6 |        0 |       0 |               0 |             46 |              0 |     115 |
| 17      | Manipur           |           0 |       2 |        0 |       0 |              13 |              7 |              0 |      22 |
| 18      | Meghalaya         |           3 |       0 |        0 |       0 |               0 |              7 |              0 |      10 |
| 19      | Mizoram           |           0 |       0 |        0 |       0 |               0 |              8 |              0 |       8 |
| 20      | Nagaland          |           0 |       0 |        0 |       0 |               0 |              2 |              0 |       2 |
| 21      | Odisha            |           8 |       0 |        0 |       0 |               0 |              6 |              0 |      14 |
| 22      | Punjab            |           5 |       0 |        0 |       0 |               0 |              4 |              0 |       9 |
| 23      | Rajasthan         |         118 |      11 |        0 |       1 |               2 |              6 |              0 |     138 |
| 24      | Sikkim            |           1 |       0 |        0 |       0 |               0 |              0 |              0 |       1 |
| 25      | Tamil Nadu        |           2 |       1 |      271 |       1 |               0 |              1 |              0 |     276 |
| 26      | Tripura           |           2 |       0 |        0 |       0 |               0 |              2 |              0 |       4 |
| 27      | Uttar Pradesh     |        1771 |     204 |        0 |       0 |               0 |              8 |              0 |    1983 |
| 28      | Uttarakhand       |         402 |       2 |        0 |       0 |               0 |              1 |              0 |     405 |
| 29      | West Bengal       |           6 |       1 |        0 |       0 |               0 |             12 |              1 |      20 |
| 30      | A&N Island        |           1 |       1 |        1 |       1 |               0 |              1 |              0 |       5 |
| 31      | Chandigarh        |           1 |       0 |        0 |       0 |               0 |              1 |              0 |       2 |
| 32      | D & N Haveli      |           0 |       0 |        0 |       0 |               0 |              0 |              0 |       0 |
| 33      | Daman & Diu       |           1 |       0 |        0 |       0 |               0 |              1 |              0 |       2 |
| 34      | Lakshadweep       |           0 |       0 |        0 |       0 |               0 |              0 |              0 |       0 |
| 35      | Puducherry        |           0 |       0 |        0 |       0 |               0 |              0 |              0 |       0 |
| 36      | Telangana         |           7 |       3 |        0 |       0 |               1 |              5 |              0 |      16 |
|         | TOTAL             |        2820 |     256 |      273 |       7 |              30 |            203 |              1 |    3590 |

Source: State Governments & concerned agencies.

State /UT wise/System wise Number of AYUSH Dispensaries as on 1 - 4- 2016

## Annexure - I

| S. No   | State /UT         | Ayurveda   | Unani   | Siddha   | Yoga   | Naturopat hy   | Homoeopa thy   | Sowa Rigpa   | Total   |
|---------|-------------------|------------|---------|----------|--------|----------------|----------------|--------------|---------|
| (1)     | (2)               | (3)        | (4)     | (5)      | (6)    | (7)            | (8)            | (9)          | (10)    |
| 1       | Andhra Pradesh    | 333        | 75      | 0        | 0      | 0              | 193            | 0            | 601     |
| 2       | Arunachal Pradesh | 17         | 1       | 0        | 0      | 0              | 95             | 0            | 113     |
| 3       | Assam             | 380        | 1       | 0        | 0      | 0              | 75             | 0            | 456     |
| 4       | Bihar             | 1082       | 449     | 0        | 0      | 0              | 644            | 0            | 2175    |
| 5       | Chhattisgarh      | 956        | 26      | 0        | 0      | 0              | 112            | 0            | 1094    |
| 6       | Delhi             | 37         | 19      | 0        | 0      | 0              | 101            | 0            | 157     |
| 7       | Goa               | 11         | 0       | 0        | 0      | 0              | 15             | 0            | 26      |
| 8       | Gujarat           | 555        | 0       | 0        | 16     | 14             | 216            | 0            | 801     |
| 9       | Haryana           | 483        | 19      | 0        | 0      | 0              | 22             | 0            | 524     |
| 10      | Himachal Pradesh  | 1112       | 3       | 0        | 0      | 0              | 14             | 4            | 1133    |
| 11      | Jammu & Kashmir   | 240        | 177     | 0        | 0      | 0              | 0              | 25           | 442     |
| 12      | Jharkhand         | 220        | 54      | 0        | 0      | 0              | 92             | 0            | 366     |
| 13      | Karnataka         | 592        | 50      | 0        | 0      | 5              | 43             | 0            | 690     |
| 14      | Kerala            | 807        | 2       | 6        | 0      | 1              | 661            | 0            | 1477    |
| 15      | Madhya Pradesh    | 1496       | 64      | 0        | 0      | 0              | 213            | 0            | 1773    |
| 16      | Maharashtra       | 466        | 25      | 0        | 0      | 0              | 1              | 0            | 492     |
| 17      | Manipur           | 36         | 15      | 0        | 17     | 13             | 201            | 0            | 282     |
| 18      | Meghalaya         | 6          | 0       | 0        | 0      | 0              | 6              | 0            | 12      |
| 19      | Mizoram           | 2          | 0       | 0        | 0      | 0              | 22             | 0            | 24      |
| 20      | Nagaland          | 109        | 0       | 0        | 0      | 1              | 93             | 0            | 203     |
| 21      | Odisha            | 624        | 9       | 0        | 35     | 30             | 638            | 0            | 1336    |
| 22      | Punjab            | 489        | 35      | 0        | 1      | 0              | 111            | 0            | 636     |
| 23      | Rajasthan         | 3577       | 120     | 0        | 0      | 3              | 252            | 0            | 3952    |
| 24      | Sikkim            | 2          | 0       | 0        | 0      | 0              | 9              | 1            | 12      |
| 25      | Tamil Nadu        | 96         | 63      | 773      | 104    | 0              | 105            | 0            | 1141    |
| 26      | Tripura           | 36         | 0       | 0        | 0      | 0              | 73             | 0            | 109     |
| 27      | Uttar Pradesh     | 340        | 49      | 0        | 0      | 0              | 1575           | 0            | 1964    |
| 28      | Uttarakhand       | 142        | 3       | 0        | 0      | 0              | 60             | 3            | 208     |
| 29      | West Bengal       | 502        | 3       | 0        | 0      | 0              | 2020           | 0            | 2525    |
| 30      | A&N Island        | 11         | 0       | 0        | 2      | 0              | 19             | 0            | 32      |
| 31      | Chandigarh        | 10         | 1       | 0        | 0      | 0              | 10             | 0            | 21      |
| 32      | D&N Haveli        | 8          | 0       | 0        | 0      | 0              | 6              | 0            | 14      |
| 33      | Daman&Diu         | 6          | 0       | 0        | 0      | 0              | 6              | 0            | 12      |
| 34      | Lakshadweep       | 8          | 0       | 0        | 0      | 0              | 7              | 0            | 15      |
| 35      | Puducherry        | 27         | 0       | 24       | 4      | 0              | 17             | 0            | 72      |
| 36      | Telangana         | 426        | 188     | 1        | 0      | 28             | 199            | 0            | 842     |
|         | TOTAL             | 15244      | 1451    | 804      | 179    | 95             | 7926           | 33           | 25732   |

Source: State Governments & concerned agencies.

## Annexure - II

## State/UT wise Number of ASU&H medicines tested and declared spurious/sub standard/adulterated during the last three years

draw th

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| S.   | Name of    | No. of medicines tested   | No. of medicines tested   | No. of medicines tested   | Declared spurious/sub -                                                 | Declared spurious/sub -                                                 | steps taken to check the quality                                                                                                                                                                                                                                                                                                                                          |
|------|------------|---------------------------|---------------------------|---------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No   | State/UTs  | 2015-16                   | 2016- 17                  | 2017-18                   | standard/adulterated drugs (year wise)                                  | standard/adulterated drugs (year wise)                                  | of medicines                                                                                                                                                                                                                                                                                                                                                              |
| 1.   | Gujarat    | 322 Ay, 05 H              | 296 Ay                    | 76 Ay                     | 2015- 16 2016- 17                                                       | 10 18                                                                   | Show cause notices issued to 8 and 21 Licenses suspended.                                                                                                                                                                                                                                                                                                                 |
| 2.   | Tripura    | 15 H                      | 87 Ay, 01 H               | 83 Ay                     | 18 01 Nil                                                               | 18 01 Nil                                                               | Inspectors are regularly samples of medicines to check quality.                                                                                                                                                                                                                                                                                                           |
| 3.   | Orissa     |                           | Nil                       |                           | Nil                                                                     | Nil                                                                     | 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 Further, random inspection and the supplied drugs are also being out by t he officials authorized purpose by the State Government.                                                             |
| 4.   | Tamil Nadu |                           | ------                    |                           | In the year 2015 - 16, 01 Ayurvedic proprietary medicine was found to a | In the year 2015 - 16, 01 Ayurvedic proprietary medicine was found to a | be There are 23 Drug Inspectors The target has been fixed for Inspectors for taking statutory every month for testing.                                                                                                                                                                                                                                                    |
| 5.   | Kerala     |                           | -----                     |                           | spurious drug. -----                                                    | spurious drug. -----                                                    | The enforcement officers of the Control Wing conduct frequent raids inspection in the market as well as manufacturing units to check the of spurious and adulterated Samples are also drawn from the and from the manufacturing firms analysis in order to ensure the drugs . Supply of 28 cases purpo rted to spurious drugs were reported in during the last few years. |
| 6.   | Delhi      | 3000 Ay, 1000 U           | 2048 Ay, 1000 U           | 600 Ay, 200 U             | 2015- 16 2016- 17 2017- 18                                              | 13 Ay , 07 11 Ay , 11 04 Ay , 01                                        | U U U Drug Control Department, Directorate AYUSH regularly do inspection and market survey samples of Ayurvedic an medicines for test/ analysis of Quality Control activity check on spurious/ su b- standard                                                                                                                                                             |

Abbreviation: Ay (Ayurveda), S (Siddha), U (Unani), H (Homoeopathy)