Lok Sabha Question No. 3398 (UNSTARRED), answered on 2019-07-12
Subject: Fake Ayurvedic and Homoeopathic Drugs
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: S. Gnanathiraviam

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

LOK  SABHA UNSTARRED  QUESTION NO. 3398 TO BE ANSWERED ON 12 TH JULY, 2019

## FAKE AYURVEDIC AND H OMOEOPATHIC DRUGS

## 3398. SHRI GNANATHIRAVIAM S.:

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

- (a) whether the Government is aware of the availability of fake Ayurvedic and Homoeopat drugs;
- (b) if so, the details thereof;
- (c) whe ther the Government proposes to take any effective steps in this regard; 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): Yes, Government is aware and concerned about the instances of contravention provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder in respect of substandard Ayurvedicand Homoeopathic medicines. State - wise statement of sub - tandard or spurious medicines for the last four years is provided in the annexure.
- ( c) & ( d): Provisions for checking fake or substandard medicines are prescribed in the D Cosmetics Act a nd Rules and Central Government has taken following measures to ensure effe quality control of medicines in the country -
- i) Quality standards of Ayurvedic and Homoeopathic medicines have been develop and  published  in  respective  Pharmacopoeias  and  Good  Manufacturing  Practi (GMP) notified under Drugs & Cosmetics Rules, 1945 for mandatory compliance the drug manufacturers.
- ii) Training programs for the State regulatory personnel and manufacturers have been organized to build up the capacity for effective quality control of medicines.

Contd……

- iii) States/UTs  are  provided  grant - in - aid  through  Centrally  Sponsored  Scheme  of National AYUSH Mission for strengthening of enforcement framework and infrastructure  of  State  pharmacies  and  drug  testing  laboratories  to  impr capacity for quality control of medicines.
- iv) Drugs & Cosmetics Rules, 1945 have been amended in respect of seeking complia to various license requirements and conditions for manufacturing of Ayurvedic and Homoeopathic medicines.
- v) Mechanism for monitoring and reporting of adverse drug reactions and mislea advertisements  &  exaggerated  claims  of  AYUSH  medicines  has  been  establish through Central Sector Scheme of Pharmacovi gilance implemented by the Ministry of AYUSH.

## State/UT wise number of Ayurvedic and Homoeopathic 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   |
|-------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|
|                   | 2015-16                                     | 2015-16                                     | 2016-17                                     | 2016-17                                     | 2017-18                                     | 2017-18                                     | 2018-19                                     | 2018-19                                     |
|                   | 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                                       | -                                           | 423A                                        | -                                           | -                                           | -                                           |
| Chhattisgarh      |                                             |                                             | 75 A                                        | --                                          | 149A                                        | 6                                           | 69A                                         | 1                                           |
| Delhi             | 3000 A                                      | 13 A                                        | 2048 A                                      | 11 A                                        | 600 A                                       | 4A                                          |                                             |                                             |
| 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                                       | 119 A                                       | 715A                                        | 99A                                         | 423A                                        | 55A                                         | 886A                                        | 69A                                         |
| Tamilnadu         | -                                           | -                                           | 1809 ASU                                    | 128                                         | 1821                                        | 74                                          | 537                                         | 33                                          |
| Tripura           | 15H                                         | -                                           | 67 ASU                                      | --                                          | 200 ASU,                                    | --                                          | 66AS U,                                     | --                                          |
| Uttarakhand       | 111 ASU                                     | 12                                          | 187 ASU                                     | -                                           | 250 ASU                                     | 53                                          | 27 ASU                                      | 3                                           |
| West Bengal       | -                                           | -                                           | 8                                           | -                                           | 0                                           | -                                           | -                                           | -                                           |