Lok Sabha Question No. 3212 (UNSTARRED), answered on 2019-07-12
Subject: Spurious Pharmacies
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Andimuthu Raja

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

LOK  SABHA UNSTARRED  QUESTION NO. 3212 TO BE ANSWERED ON 12 TH JULY, 2019

## SPURIOUS PHARMACIES

## 3212. SHRI A. RAJA:

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

- (a)  whether  the  cases  of  low  quality  medicines  being  marketed  by  spurious  pharmacies come  to  the  knowledge  of  the  Government  during  the  last  three  years  and  th e  current  year, State/UT - wise;
- (b) the action taken/being taken by the Government in this regard; and
- (c)  whether  the  Government  is  planning  to  develop  any  mechanism  to  check  such  spurio pharmacies 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) & (b):     The manufacturing for sale and distribution of medicines is primarily regulated in the countryunder the provisions of Drugs & Cosmetics Act, 1940 & Rules 1945 made thereunder. this purpose a system of licensing and inspection of drug manufacturing units by the Drug Authorities  appointed  by  the  respective  Stat e  Governments  is  in  place  for  quality  control medicines.  Every licensed drug manufacturing unit is required to comply with all the co license  as  prescribed  under  Drugs  &  Cosmetics  Rules,  1945.  Since  the  enforcement  o provisions for me dicines as prescribed in the Drugs & Cosmetics Act, 1940 and Rules thereun vested with the State Governments, the State Licensing Authorities are empowered to take violation of any of the conditions of such licenses including monitory punis hment and prosecution in appropriate  Court  of  Law.  Statement  of  state -wise  r ported  cases  of  spurious  or  substandar Ayurvedic, Siddha, Unani and Homoeopathy medicines during the last four years is provided in the Annexure .

Contd……..

(c): The mechanism of checking spurious pharmacies is prescribed in the Drugs & Cosmetic and Rules. Central Government has taken following regulatory measures to ensure effectiv control of medicines in the country -

- i) The Drugs and Cosmetics Act, 19 40 has been amended to provide stringent penalties f manufacture of spurious and adulterated drugs including provision for certain cogni non- bail able offences.
2. ii)Guidelines for taking action on samples of drugs declared spurious or not of sta ndard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, have been circulated to the State Drug Controllers for uniform implementation.
3. iii) States / UTs were requested to set up special Courts for trial of offence s under the Drugs and Cosmetics Act for speedy disposal. 28 States are reported to have set up designat Courts for trial of cases of spurious and sub - standard drugs.
4. iv)  Number  of  regulatory  posts  has  been  increased  and  strengthening  of  State  enf orcement framework, pharmacies and drug testing laboratories supported to improve the capac quality control of medicines.
- v)  Drugs & Cosmetics Rules, 1945 have been amended in respect of seeking complian various license requirements for manuf acturing of medicines.

## State/UT wise number of ASU&H medicines tested and declared spurious or sub -standard in the last four years

| State/UT          | Samples tested by Drug Testing Laboratory   | Samples tested by Drug Testing Laboratory   | Samples tested by Drug Testing Laboratory   | Samples tested by Drug Testing Laboratory   | Samples tested by Drug Testing Laboratory   | Samples tested by Drug Testing Laboratory   | Samples tested by Drug Testing Laboratory   | Samples tested by Drug Testing Laboratory   |
|-------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|
| State/UT          | 2015- 16                                    | 2015- 16                                    | 2016- 17                                    | 2016- 17                                    | 2017- 18                                    | 2017- 18                                    | 2018- 19                                    | 2018- 19                                    |
| State/UT          | Tested                                      | Failed/Sub Standard                         | Tested                                      | Failed/Sub standard                         | Tested                                      | Failed/Sub standard                         | Tested                                      | Failed/Sub standard                         |
| Arunachal Pradesh | -                                           | -                                           | 91 A&H                                      | NA                                          | 145                                         | NA                                          | 80                                          | NA                                          |
| Assam             | 319 A                                       | 4                                           | 146 A                                       | -                                           | 115A                                        | -                                           | 106A                                        | -                                           |
| Chandigarh        | -                                           | -                                           | 715 A, 48U                                  | -                                           | 423A, 9 U                                   | -                                           | -                                           | -                                           |
| Chhattisgarh      |                                             |                                             | 75 A                                        | --                                          | 149A                                        | 6                                           | 69A                                         | 1                                           |
| Delhi             | 3000 A, 1000 U                              | 13 A, 7 U                                   | 2048 A, 100U                                | 11 A, 11U                                   | 600 A, 200U                                 | 4A, 1U                                      |                                             |                                             |
| Goa               | -                                           | -                                           | 10                                          | -                                           | 1                                           | -                                           | -                                           | -                                           |
| Gujarat           | 322A, 5H                                    | 10                                          | 267 ASU, 58H                                | NA                                          | 298 ASU, 4H                                 | NA                                          | 110 ASU                                     | NA                                          |
| Himachal Pradesh  | -                                           | -                                           | 748 ASU                                     | 53                                          | 577 ASU                                     | 61                                          | 94 ASU                                      | 4                                           |
| Jharkhand         | -                                           | -                                           | -                                           | -                                           | 33H                                         | 3                                           | -                                           | -                                           |
| Karnataka         | -                                           | -                                           | 1071 A, 87H                                 | -                                           | 1026A, 30H                                  | -                                           | -                                           | -                                           |
| Kerala            | 297A                                        | 7                                           | 297A                                        | 5                                           | 578                                         | 25                                          | 724                                         | 9                                           |
| Maharashtra       | -                                           | -                                           | 350                                         | -                                           | 320                                         | -                                           | -                                           | -                                           |
| Manipur           | NA                                          | -                                           | NA                                          | -                                           | NA                                          | -                                           | --                                          | -                                           |
| Meghalaya         | 15A, 10H                                    | NA                                          | 15A, 15H                                    | NA                                          | 11A, 9H                                     | NA                                          | 5A, 2H                                      | NA                                          |
| Mizoram           | -                                           | -                                           | 31                                          | 11                                          | -                                           | -                                           | -                                           | -                                           |
| Nagaland          | -                                           | -                                           | NA                                          | -                                           | NA                                          | -                                           | -                                           | -                                           |
| Odisha            | -                                           | -                                           | 45                                          | -                                           | 53                                          | -                                           | -                                           | -                                           |
| Puducherry        | -                                           | -                                           | -                                           | -                                           | -                                           | -                                           | -                                           | -                                           |
| Punjab            | 921 A, 12U                                  | 119 A, 3 U                                  | 715A, 48U                                   | 99A, 2U                                     | 423A, 9U                                    | 55A                                         | 886A                                        | 69A                                         |
| Tamilnadu         | -                                           | -                                           | 1809                                        | 128                                         | 1821                                        | 74                                          | 537                                         | 33                                          |
| Tripura           | 15H                                         | -                                           | 67 ASU                                      | --                                          | 200 ASU, 1H                                 | --                                          | 66ASU, 132H                                 | --                                          |
| Uttarakhand       | 111 ASU                                     | 12                                          | 187 ASU                                     | -                                           | 250 ASU                                     | 53                                          | 27 ASU                                      | 3                                           |
| West Bengal       | -                                           | -                                           | 8                                           | -                                           | 0                                           | -                                           | -                                           | -                                           |