Lok Sabha Question No. 1012 (UNSTARRED), answered on 2022-07-22
Subject: Ayush Medicine
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Anurag Sharma, Dr. T. Sumathy (a) Thamizhachi Thangapandian

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO.1012 TO BE ANSWERED ON 22 ND  JULY, 2022

## 'AYUSH MEDICINES'

## 1012. SHRI ANURAG SHARMA: DR. T. SUMATHY (A) THAMIZHACHI THANGAPANDIAN:

Will the Minister of AYUSH be pleased to state:

- a) whether the approval of several  indigenous medicines from the ministry of Ayush have been  pending since last three-four years;
- b) if so, the details thereof and their current status;
- c) whether the applications for approval of medicines from the AYUSH Ministry have been deliberately kept pending for long periods alongwith only few approvals; and
- d) if  so,  the  detailed  list  of  Ayush  medicines  registered  for  approval,  finally  approved, rejected and pending during the last  five years including the state of Uttar Pradesh?

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

(a)  &  (b)    No  Sir,  As  prescribed  in  Drugs  and  Cosmetics  Act  1940  and  Rules  1945  made thereunder,  enforcement  of  the  legal  provisions pertaining  to  Quality  Control  and  issuance  of drug license of Ayurveda, Siddha, and Unani drugs, is vested with the State drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government. Rule 158-B in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Ayurvedic, Siddha and Unani medicines in accordance with the proof of safety and effectiveness.

As per  allocation  of  Government  Business  Rules  1961  and  Drugs  and  Cosmetics  Act, 1940 and Rules 1945, approval of any product is not granted by the Ministry of Ayush in Central Government. It is granted by the concerned State/UT Government.

(c) & (d) As per the information received from State/ UT Governments, list of Ayush medicines registered  for  approval/finally  approved/rejected  and  pending  during  the  last  five  years  is  at Annexure I.

******

## Annexure-I

|   S.no. | Name of the State/UT   | Information received from State/ UTs regarding Ayush medicines registered for approval/got approved/rejected approval and pending approval in the last five years   | Information received from State/ UTs regarding Ayush medicines registered for approval/got approved/rejected approval and pending approval in the last five years   | Information received from State/ UTs regarding Ayush medicines registered for approval/got approved/rejected approval and pending approval in the last five years   | Information received from State/ UTs regarding Ayush medicines registered for approval/got approved/rejected approval and pending approval in the last five years   | Information received from State/ UTs regarding Ayush medicines registered for approval/got approved/rejected approval and pending approval in the last five years   | Information received from State/ UTs regarding Ayush medicines registered for approval/got approved/rejected approval and pending approval in the last five years   |
|---------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Arunachal Pradesh      | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              |
|       2 | Madhya Pradesh         | 3000 approval given                                                                                                                                                 | 3000 approval given                                                                                                                                                 | 3000 approval given                                                                                                                                                 | 3000 approval given                                                                                                                                                 | 3000 approval given                                                                                                                                                 | 3000 approval given                                                                                                                                                 |
|       3 | Goa                    | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              |
|       4 | Uttar Pradesh          | Ayush medicines registered for approval - 315 Ayush medicines approved - 300 Applications pending for approval due to incomplete documents- 15                      | Ayush medicines registered for approval - 315 Ayush medicines approved - 300 Applications pending for approval due to incomplete documents- 15                      | Ayush medicines registered for approval - 315 Ayush medicines approved - 300 Applications pending for approval due to incomplete documents- 15                      | Ayush medicines registered for approval - 315 Ayush medicines approved - 300 Applications pending for approval due to incomplete documents- 15                      | Ayush medicines registered for approval - 315 Ayush medicines approved - 300 Applications pending for approval due to incomplete documents- 15                      | Ayush medicines registered for approval - 315 Ayush medicines approved - 300 Applications pending for approval due to incomplete documents- 15                      |
|       5 | Himachal Pradesh       | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              |
|       6 | Uttarakhand            | Year                                                                                                                                                                | Permission                                                                                                                                                          | Permission                                                                                                                                                          | Rejected                                                                                                                                                            | Rejected                                                                                                                                                            | Pending                                                                                                                                                             |
|       6 | Uttarakhand            | 2019-20                                                                                                                                                             | approximately 2700                                                                                                                                                  | approximately 2700                                                                                                                                                  | 0                                                                                                                                                                   | 0                                                                                                                                                                   | 0                                                                                                                                                                   |
|       6 | Uttarakhand            | 2020-21                                                                                                                                                             | approximately 3000                                                                                                                                                  | approximately 3000                                                                                                                                                  | 0                                                                                                                                                                   | 0                                                                                                                                                                   | 0                                                                                                                                                                   |
|       6 | Uttarakhand            | 2021-22                                                                                                                                                             | approximately 2500                                                                                                                                                  | approximately 2500                                                                                                                                                  | 0                                                                                                                                                                   | 0                                                                                                                                                                   | 0                                                                                                                                                                   |
|       6 | Uttarakhand            | 2022-23                                                                                                                                                             | approximately 354                                                                                                                                                   | approximately 354                                                                                                                                                   | 0                                                                                                                                                                   | 0                                                                                                                                                                   | 0                                                                                                                                                                   |
|       7 | Tamil Nadu             | Year                                                                                                                                                                | No. of ASU application received                                                                                                                                     | No. of                                                                                                                                                              | No. of                                                                                                                                                              | No. of ASU pending application No. of ASU rejected application                                                                                                      | No. of ASU pending application No. of ASU rejected application                                                                                                      |
|       7 | Tamil Nadu             | 2018                                                                                                                                                                | 40                                                                                                                                                                  | 33                                                                                                                                                                  | 33                                                                                                                                                                  | 7                                                                                                                                                                   | 7                                                                                                                                                                   |
|       7 | Tamil Nadu             | 2019                                                                                                                                                                | 24                                                                                                                                                                  | 22                                                                                                                                                                  | 22                                                                                                                                                                  |                                                                                                                                                                     | 2                                                                                                                                                                   |
|       7 | Tamil Nadu             | 2020                                                                                                                                                                | 45                                                                                                                                                                  | 40                                                                                                                                                                  | 40                                                                                                                                                                  | 3                                                                                                                                                                   | 3                                                                                                                                                                   |
|       7 | Tamil Nadu             | 2021                                                                                                                                                                | 37                                                                                                                                                                  | 31 6                                                                                                                                                                | 31 6                                                                                                                                                                | -                                                                                                                                                                   | -                                                                                                                                                                   |
|       7 | Tamil Nadu             | 2022 (up to 30.06.2022)                                                                                                                                             | 29                                                                                                                                                                  | 13 16                                                                                                                                                               | 13 16                                                                                                                                                               |                                                                                                                                                                     |                                                                                                                                                                     |
|       8 | Karnataka              |                                                                                                                                                                     |                                                                                                                                                                     |                                                                                                                                                                     |                                                                                                                                                                     |                                                                                                                                                                     |                                                                                                                                                                     |
|       8 | Karnataka              | Year                                                                                                                                                                | Ayush medicines registered for approval                                                                                                                             | Approved Rejected                                                                                                                                                   | Approved Rejected                                                                                                                                                   | Pending approval                                                                                                                                                    | Pending approval                                                                                                                                                    |
|       8 | Karnataka              | April 2019 to July 2022                                                                                                                                             | 4768                                                                                                                                                                | 4608 63                                                                                                                                                             | 4608 63                                                                                                                                                             | 97                                                                                                                                                                  | 97                                                                                                                                                                  |
|       9 | Puducherry             | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 | NIL                                                                                                                                                                 |
|      10 | Jharkhand              | Total 4280 products. No application pending.                                                                                                                        | Total 4280 products. No application pending.                                                                                                                        | Total 4280 products. No application pending.                                                                                                                        | Total 4280 products. No application pending.                                                                                                                        | Total 4280 products. No application pending.                                                                                                                        | Total 4280 products. No application pending.                                                                                                                        |
|      11 | Rajasthan              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              | No application pending                                                                                                                                              |