Lok Sabha Question No. 2224 (UNSTARRED), answered on 2023-12-15
Subject: Action against Manufacturing of Spurious Drugs
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Kishan Kapoor

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 2224 TO BE ANSWERED ON 15 th  DECEMBER, 2023

'Action against Manufacturing of Spurious Drugs'

## 2224. SHRI KISHAN KAPOOR:

Will the Minister of AYUSH be pleased to state: (a)  the  number  of  complaints  received  by  the  Government  regarding  the  manufacturing  of spurious AYUSH drugs and products in the country during the last years and the current year, State/UT-wise; and (b)  the  action  taken/proposed  to  be  taken  by  the  Government  against  such  companies/entities,

State/ UT-wise?

## ANSWER THE MINISTER OF AYUSH (SHRI SARBANANDA SONOWAL)

(a)and  (b)  As  prescribed  in  Drugs  and  Cosmetics  Act  1940  and  Rules  made  thereunder, enforcement of the legal provisions pertaining to Quality Control and issuance of drug license of Ayurveda, Siddha,  Unani and Homoeopathy drugs, is vested with the State Drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government. 158B in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to  manufacture  Ayurvedic,  Siddha,  Unani  medicines  and  Rule  85  (A  to  I)  in  the  Drugs  and Cosmetics  Rules,  1945  provides  the  regulatory  guidelines  for  issue  of  license  to  manufacture Homoeopathy  medicines.  It  is  mandatory  for  the  manufacturers  to  adhere  to  the  prescribed requirements  for  licensing  of  manufacturing  units  &  medicines  including  proof  of  safety  & effectiveness, compliance with the Good Manufacturing Practices (GMP) as per Schedule T &

Schedule M-I of Drugs and Cosmetics Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

Further,  Provisions  related  to  Spurious  Ayurveda,  Siddha  and  Unani  drugs  are mentioned under section 33EEA, 33EEC, 33-I and 33J of the Drugs and Cosmetics Act, 1940 and Provisions related to Spurious Homoeopathy drugs are mentioned under section 9B, 10, 13, 17B,  18,  27,  31,  36  AB  and  36  AC  of  the  Drugs  and  Cosmetics  Act,  1940.  As  per  the information  received  from  various  States/UTs  governments,  the  details  of  the  number  of complaints received by the Government regarding the manufacturing of spurious AYUSH drugs and products along with the action taken/proposed to be taken by the Government against such companies/entities are at Annexure-I .

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State/ UT-wise details of number of complaints received by the Government regarding the manufacturing of spurious AYUSH  drugs and products along with the action taken/proposed  to  be  taken  by  the  Government  against  such  companies/entities  are as follows -

|   S.no. | Name of the State/ UT   | Details of number of complaints received                                                     | Details of number of complaints received                                                     | Details of the action taken/proposed to be taken                                                                                    | Details of the action taken/proposed to be taken                                                                                    |
|---------|-------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Maharashtra             |                                                                                              |                                                                                              |                                                                                                                                     |                                                                                                                                     |
|       1 | Maharashtra             | Time period                                                                                  | No. of Complaint received                                                                    |                                                                                                                                     |                                                                                                                                     |
|       1 | Maharashtra             | 01.04.2022- 31.03.2023                                                                       | 08                                                                                           |                                                                                                                                     | No. of Complaint received                                                                                                           |
|       1 | Maharashtra             | 01.04.2023 to till date                                                                      | NIL                                                                                          |                                                                                                                                     | 08 samples were declared NSQ and Prosecutions filed. Investigation                                                                  |
|       1 | Maharashtra             |                                                                                              |                                                                                              |                                                                                                                                     | under process.                                                                                                                      |
|       1 | Maharashtra             |                                                                                              |                                                                                              |                                                                                                                                     | NIL                                                                                                                                 |
|       2 | West Bengal             | 08 complaints regarding misbranded and spurious drugs are received                           | in                                                                                           | to till date Regarding normal complaints 06 police raids from the office of West Bengal, Licensing Authority had been initiated for | to till date Regarding normal complaints 06 police raids from the office of West Bengal, Licensing Authority had been initiated for |
|       3 | Jharkhand               | Complain of one product (REPL Orthovit Capsule) manufactured by Renovation Exports Pvt. Ltd. | Complain of one product (REPL Orthovit Capsule) manufactured by Renovation Exports Pvt. Ltd. | Product permission cancelled and Prosecution filed.                                                                                 | Product permission cancelled and Prosecution filed.                                                                                 |
|       4 | Rajasthan               | NIL                                                                                          | NIL                                                                                          | NIL                                                                                                                                 | NIL                                                                                                                                 |
|       5 | Goa                     | NIL                                                                                          | NIL                                                                                          | NIL                                                                                                                                 | NIL                                                                                                                                 |
|       6 | Odisha                  | NIL                                                                                          | NIL                                                                                          | NIL                                                                                                                                 | NIL                                                                                                                                 |
|       7 | Puducherry              | NIL                                                                                          | NIL                                                                                          | NIL                                                                                                                                 | NIL                                                                                                                                 |
|       8 | Kerala                  | NIL                                                                                          | NIL                                                                                          | NIL                                                                                                                                 | NIL                                                                                                                                 |
|       9 | Karnataka               | NIL                                                                                          | NIL                                                                                          | NIL                                                                                                                                 | NIL                                                                                                                                 |
|      10 | Haryana                 | NIL                                                                                          | NIL                                                                                          | NIL                                                                                                                                 | NIL                                                                                                                                 |
|      11 | Delhi                   | NIL                                                                                          | NIL                                                                                          | NIL                                                                                                                                 | NIL                                                                                                                                 |
|      12 | Arunachal Pradesh       | NIL                                                                                          | NIL                                                                                          | NIL NIL                                                                                                                             | NIL NIL                                                                                                                             |
|      13 | Uttarakhand             |                                                                                              |                                                                                              |                                                                                                                                     |                                                                                                                                     |