Lok Sabha Question No. 4126 (UNSTARRED), answered on 2023-03-24
Subject: Indigenous Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Omprakash Bhupalsinh alias Pawan Rajenimbalkar, Sanghamitra Maurya, Sanjay Haribhau Jadhav

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 4126 TO BE ANSWERED ON 24 TH  MARCH, 2023

## INDIGENOUS MEDICINES

## 4126.   SHRI OMPRAKASH BHUPALSINH ALIAS PAWAN RAJENIMBALKAR: DR. SANGHMITRA MAURYA: SHRI SANJAY JADHAV:

Will the Minister of AYUSH be pleased to state:

- (a) the details of indigenous medicines whose approval is pending with the Government during the last three years and the current year;
- (b)  whether  applications  for  approval  for  many  medicines  are  pending  with  the  Government since a long time and a very few medicines have been approved; and
- (c)  if  so,  the  details  thereof  along  with  the  list  of  AYUSH  medicines  approved,  rejected  and pending for approval during the last three years?

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

(a)  to    (c)  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,  Unani and Homoeopathy 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, 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.

Ministry of Ayush has set up a Interdisciplinary Technical Review Committee (ITRC) for the examination of the applications/ claims on patent & proprietary (Ayurveda, Siddha, Unani & Homoeopathy)  ASU&H  medicines/classical  ASU&H  medicines  with  new  indication  or  Repurposing of licensed P&P, ASU&H medicines for Covid-19 and label claim for Covid-19.The details of total number of applications/claims received, Applications / claims were not put before the ITRC as  no  detailed  documents  were  provided  by  the  applicant,  applications/claims  discussed  in ITRC, not recommended, pending and recommended are as follows:

| Total no. of applications/claims received                                                                          |   101 |
|--------------------------------------------------------------------------------------------------------------------|-------|
| No. of applications / claims were not put before the ITRC as no detailed documents were provided by the applicant. |    50 |
| No. of applications / claims discussed in ITRC                                                                     |    51 |
| No. of applications/Claims not recommended                                                                         |    47 |
| No. of applications pending at the end of applicant.                                                               |    01 |
| No. of applications/Claims recommended.                                                                            |    03 |

As per the information received from State/UT government, the detailed list of AYUSH medicines approved, rejected and pending for approval during the last three years are as follows -

|   S.no. | Name of the State/UT   | Detailed list of AYUSH medicines approved, rejected and pending for approval during the last three years                                                                                                                                                                                                                                                                         | Detailed list of AYUSH medicines approved, rejected and pending for approval during the last three years                                                                                                                                                                                                                                                                         | Detailed list of AYUSH medicines approved, rejected and pending for approval during the last three years                                                                                                                                                                                                                                                                         | Detailed list of AYUSH medicines approved, rejected and pending for approval during the last three years                                                                                                                                                                                                                                                                         | Detailed list of AYUSH medicines approved, rejected and pending for approval during the last three years                                                                                                                                                                                                                                                                         | Detailed list of AYUSH medicines approved, rejected and pending for approval during the last three years                                                                                                                                                                                                                                                                         |
|---------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Andhra Pradesh         | Eye drops and P, K, L, F of Sri. B. Anandaih of Mutthukura Mandal of Nellore Dist. which were claimed to have high success rate in Covid-19 were rejected for not complying with the Pharmacopoeial standards prescribed by PCIM&H and Pharmaceutical standards prescribed by Ayurvedic texts and also the statutory standards prescribed by D&C Act, 1940 and Rules thereunder. | Eye drops and P, K, L, F of Sri. B. Anandaih of Mutthukura Mandal of Nellore Dist. which were claimed to have high success rate in Covid-19 were rejected for not complying with the Pharmacopoeial standards prescribed by PCIM&H and Pharmaceutical standards prescribed by Ayurvedic texts and also the statutory standards prescribed by D&C Act, 1940 and Rules thereunder. | Eye drops and P, K, L, F of Sri. B. Anandaih of Mutthukura Mandal of Nellore Dist. which were claimed to have high success rate in Covid-19 were rejected for not complying with the Pharmacopoeial standards prescribed by PCIM&H and Pharmaceutical standards prescribed by Ayurvedic texts and also the statutory standards prescribed by D&C Act, 1940 and Rules thereunder. | Eye drops and P, K, L, F of Sri. B. Anandaih of Mutthukura Mandal of Nellore Dist. which were claimed to have high success rate in Covid-19 were rejected for not complying with the Pharmacopoeial standards prescribed by PCIM&H and Pharmaceutical standards prescribed by Ayurvedic texts and also the statutory standards prescribed by D&C Act, 1940 and Rules thereunder. | Eye drops and P, K, L, F of Sri. B. Anandaih of Mutthukura Mandal of Nellore Dist. which were claimed to have high success rate in Covid-19 were rejected for not complying with the Pharmacopoeial standards prescribed by PCIM&H and Pharmaceutical standards prescribed by Ayurvedic texts and also the statutory standards prescribed by D&C Act, 1940 and Rules thereunder. | Eye drops and P, K, L, F of Sri. B. Anandaih of Mutthukura Mandal of Nellore Dist. which were claimed to have high success rate in Covid-19 were rejected for not complying with the Pharmacopoeial standards prescribed by PCIM&H and Pharmaceutical standards prescribed by Ayurvedic texts and also the statutory standards prescribed by D&C Act, 1940 and Rules thereunder. |
|       2 | Tamil Nadu             |                                                                                                                                                                                                                                                                                                                                                                                  | Year                                                                                                                                                                                                                                                                                                                                                                             | No. of ASU applications received                                                                                                                                                                                                                                                                                                                                                 | No. of ASU applications approved                                                                                                                                                                                                                                                                                                                                                 | No. of ASU pending applications                                                                                                                                                                                                                                                                                                                                                  | No. of ASU rejected applications                                                                                                                                                                                                                                                                                                                                                 |
|       2 | Tamil Nadu             |                                                                                                                                                                                                                                                                                                                                                                                  | 2020                                                                                                                                                                                                                                                                                                                                                                             | 45                                                                                                                                                                                                                                                                                                                                                                               | 40                                                                                                                                                                                                                                                                                                                                                                               | 2                                                                                                                                                                                                                                                                                                                                                                                | 3                                                                                                                                                                                                                                                                                                                                                                                |
|       2 | Tamil Nadu             |                                                                                                                                                                                                                                                                                                                                                                                  | 2021                                                                                                                                                                                                                                                                                                                                                                             | 37                                                                                                                                                                                                                                                                                                                                                                               | 32                                                                                                                                                                                                                                                                                                                                                                               | 5                                                                                                                                                                                                                                                                                                                                                                                | -                                                                                                                                                                                                                                                                                                                                                                                |
|       2 | Tamil Nadu             |                                                                                                                                                                                                                                                                                                                                                                                  | 2022                                                                                                                                                                                                                                                                                                                                                                             | 64                                                                                                                                                                                                                                                                                                                                                                               | 60                                                                                                                                                                                                                                                                                                                                                                               | 4                                                                                                                                                                                                                                                                                                                                                                                | -                                                                                                                                                                                                                                                                                                                                                                                |

|    |               | 2023 (up to 28.02.2023)                                                                                                                                                                                                                                                                                                                                                                                | 2023 (up to 28.02.2023)                                                                                                                                                                                                                                                                                                                                                                                | 2023 (up to 28.02.2023)                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                                                                                                                                                                        | 3                                                                                                                                                                                                                                                                                                                                                                                                      | 3                                                                                                                                                                                                                                                                                                                                                                                                      | 4                                                                                                                                                                                                                                                                                                                                                                                                      | 4                                                                                                                                                                                                                                                                                                                                                                                                      | -                                                                                                                                                                                                                                                                                                                                                                                                      |
|----|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|  3 | Karnataka     | Approval of 95 Ayush medicines is pending and 51 Ayush medicines have been rejected. From January 2020 to March, 2023, 3930 Ayush products have been approved.                                                                                                                                                                                                                                         | Approval of 95 Ayush medicines is pending and 51 Ayush medicines have been rejected. From January 2020 to March, 2023, 3930 Ayush products have been approved.                                                                                                                                                                                                                                         | Approval of 95 Ayush medicines is pending and 51 Ayush medicines have been rejected. From January 2020 to March, 2023, 3930 Ayush products have been approved.                                                                                                                                                                                                                                         | Approval of 95 Ayush medicines is pending and 51 Ayush medicines have been rejected. From January 2020 to March, 2023, 3930 Ayush products have been approved.                                                                                                                                                                                                                                         | Approval of 95 Ayush medicines is pending and 51 Ayush medicines have been rejected. From January 2020 to March, 2023, 3930 Ayush products have been approved.                                                                                                                                                                                                                                         | Approval of 95 Ayush medicines is pending and 51 Ayush medicines have been rejected. From January 2020 to March, 2023, 3930 Ayush products have been approved.                                                                                                                                                                                                                                         | Approval of 95 Ayush medicines is pending and 51 Ayush medicines have been rejected. From January 2020 to March, 2023, 3930 Ayush products have been approved.                                                                                                                                                                                                                                         | Approval of 95 Ayush medicines is pending and 51 Ayush medicines have been rejected. From January 2020 to March, 2023, 3930 Ayush products have been approved.                                                                                                                                                                                                                                         | Approval of 95 Ayush medicines is pending and 51 Ayush medicines have been rejected. From January 2020 to March, 2023, 3930 Ayush products have been approved.                                                                                                                                                                                                                                         | Approval of 95 Ayush medicines is pending and 51 Ayush medicines have been rejected. From January 2020 to March, 2023, 3930 Ayush products have been approved.                                                                                                                                                                                                                                         |
|  4 | Odisha        |                                                                                                                                                                                                                                                                                                                                                                                                        | Year No. for Ayurvedic                                                                                                                                                                                                                                                                                                                                                                                 | Year No. for Ayurvedic                                                                                                                                                                                                                                                                                                                                                                                 | Year No. for Ayurvedic                                                                                                                                                                                                                                                                                                                                                                                 | of applications                                                                                                                                                                                                                                                                                                                                                                                        | of applications                                                                                                                                                                                                                                                                                                                                                                                        | No. of applications for Ayush                                                                                                                                                                                                                                                                                                                                                                          | No. of applications for Ayush                                                                                                                                                                                                                                                                                                                                                                          | No. of applications for Ayush medicines pending for approval                                                                                                                                                                                                                                                                                                                                           | No. of applications for Ayush medicines pending for approval                                                                                                                                                                                                                                                                                                                                           |
|  4 | Odisha        |                                                                                                                                                                                                                                                                                                                                                                                                        | 2020                                                                                                                                                                                                                                                                                                                                                                                                   | 2020                                                                                                                                                                                                                                                                                                                                                                                                   | 2020                                                                                                                                                                                                                                                                                                                                                                                                   | 13                                                                                                                                                                                                                                                                                                                                                                                                     | 13                                                                                                                                                                                                                                                                                                                                                                                                     | 1                                                                                                                                                                                                                                                                                                                                                                                                      | 1                                                                                                                                                                                                                                                                                                                                                                                                      | NIL                                                                                                                                                                                                                                                                                                                                                                                                    | NIL                                                                                                                                                                                                                                                                                                                                                                                                    |
|  4 | Odisha        |                                                                                                                                                                                                                                                                                                                                                                                                        | 2021                                                                                                                                                                                                                                                                                                                                                                                                   | 2021                                                                                                                                                                                                                                                                                                                                                                                                   | 2021                                                                                                                                                                                                                                                                                                                                                                                                   | 16                                                                                                                                                                                                                                                                                                                                                                                                     | 16                                                                                                                                                                                                                                                                                                                                                                                                     | 1                                                                                                                                                                                                                                                                                                                                                                                                      | 1                                                                                                                                                                                                                                                                                                                                                                                                      | NIL                                                                                                                                                                                                                                                                                                                                                                                                    | NIL                                                                                                                                                                                                                                                                                                                                                                                                    |
|  4 | Odisha        |                                                                                                                                                                                                                                                                                                                                                                                                        | 2022                                                                                                                                                                                                                                                                                                                                                                                                   | 2022                                                                                                                                                                                                                                                                                                                                                                                                   | 2022                                                                                                                                                                                                                                                                                                                                                                                                   | 15                                                                                                                                                                                                                                                                                                                                                                                                     | 15                                                                                                                                                                                                                                                                                                                                                                                                     | 1                                                                                                                                                                                                                                                                                                                                                                                                      | 1                                                                                                                                                                                                                                                                                                                                                                                                      | NIL                                                                                                                                                                                                                                                                                                                                                                                                    | NIL                                                                                                                                                                                                                                                                                                                                                                                                    |
|  5 | Uttarakhand   |  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In current year 2022-23 approximately 2600 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected. |  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In current year 2022-23 approximately 2600 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected. |  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In current year 2022-23 approximately 2600 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected. |  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In current year 2022-23 approximately 2600 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected. |  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In current year 2022-23 approximately 2600 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected. |  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In current year 2022-23 approximately 2600 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected. |  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In current year 2022-23 approximately 2600 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected. |  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In current year 2022-23 approximately 2600 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected. |  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In current year 2022-23 approximately 2600 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected. |  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected.  In current year 2022-23 approximately 2600 Ayurvedic Patent & Proprietary Products approved, no application is pending and rejected. |
|  6 | Uttar Pradesh | 37 applications from last three years and 118 applications in current year are pending for approval. 220 Ayush medicines applications registered for approval 183 got approved and 37 applications are pending for approval.                                                                                                                                                                           | 37 applications from last three years and 118 applications in current year are pending for approval. 220 Ayush medicines applications registered for approval 183 got approved and 37 applications are pending for approval.                                                                                                                                                                           | 37 applications from last three years and 118 applications in current year are pending for approval. 220 Ayush medicines applications registered for approval 183 got approved and 37 applications are pending for approval.                                                                                                                                                                           | 37 applications from last three years and 118 applications in current year are pending for approval. 220 Ayush medicines applications registered for approval 183 got approved and 37 applications are pending for approval.                                                                                                                                                                           | 37 applications from last three years and 118 applications in current year are pending for approval. 220 Ayush medicines applications registered for approval 183 got approved and 37 applications are pending for approval.                                                                                                                                                                           | 37 applications from last three years and 118 applications in current year are pending for approval. 220 Ayush medicines applications registered for approval 183 got approved and 37 applications are pending for approval.                                                                                                                                                                           | 37 applications from last three years and 118 applications in current year are pending for approval. 220 Ayush medicines applications registered for approval 183 got approved and 37 applications are pending for approval.                                                                                                                                                                           | 37 applications from last three years and 118 applications in current year are pending for approval. 220 Ayush medicines applications registered for approval 183 got approved and 37 applications are pending for approval.                                                                                                                                                                           | 37 applications from last three years and 118 applications in current year are pending for approval. 220 Ayush medicines applications registered for approval 183 got approved and 37 applications are pending for approval.                                                                                                                                                                           | 37 applications from last three years and 118 applications in current year are pending for approval. 220 Ayush medicines applications registered for approval 183 got approved and 37 applications are pending for approval.                                                                                                                                                                           |
|  7 | Kerala        | Details of applications pending for approval is as follows-                                                                                                                                                                                                                                                                                                                                            | Details of applications pending for approval is as follows-                                                                                                                                                                                                                                                                                                                                            | Details of applications pending for approval is as follows-                                                                                                                                                                                                                                                                                                                                            | Details of applications pending for approval is as follows-                                                                                                                                                                                                                                                                                                                                            | Details of applications pending for approval is as follows-                                                                                                                                                                                                                                                                                                                                            | Details of applications pending for approval is as follows-                                                                                                                                                                                                                                                                                                                                            | Details of applications pending for approval is as follows-                                                                                                                                                                                                                                                                                                                                            | Details of applications pending for approval is as follows-                                                                                                                                                                                                                                                                                                                                            | Details of applications pending for approval is as follows-                                                                                                                                                                                                                                                                                                                                            | Details of applications pending for approval is as follows-                                                                                                                                                                                                                                                                                                                                            |
|  7 | Kerala        | Year                                                                                                                                                                                                                                                                                                                                                                                                   | Year                                                                                                                                                                                                                                                                                                                                                                                                   | Year                                                                                                                                                                                                                                                                                                                                                                                                   | Year                                                                                                                                                                                                                                                                                                                                                                                                   | Pending approval                                                                                                                                                                                                                                                                                                                                                                                       | Pending approval                                                                                                                                                                                                                                                                                                                                                                                       | Pending approval                                                                                                                                                                                                                                                                                                                                                                                       | Pending approval                                                                                                                                                                                                                                                                                                                                                                                       | Pending approval                                                                                                                                                                                                                                                                                                                                                                                       | Pending approval                                                                                                                                                                                                                                                                                                                                                                                       |
|  7 | Kerala        | 2020                                                                                                                                                                                                                                                                                                                                                                                                   | 2020                                                                                                                                                                                                                                                                                                                                                                                                   | 2020                                                                                                                                                                                                                                                                                                                                                                                                   | 2020                                                                                                                                                                                                                                                                                                                                                                                                   | 9                                                                                                                                                                                                                                                                                                                                                                                                      | 9                                                                                                                                                                                                                                                                                                                                                                                                      | 9                                                                                                                                                                                                                                                                                                                                                                                                      | 9                                                                                                                                                                                                                                                                                                                                                                                                      | 9                                                                                                                                                                                                                                                                                                                                                                                                      | 9                                                                                                                                                                                                                                                                                                                                                                                                      |
|  7 | Kerala        | 2021                                                                                                                                                                                                                                                                                                                                                                                                   | 2021                                                                                                                                                                                                                                                                                                                                                                                                   | 2021                                                                                                                                                                                                                                                                                                                                                                                                   | 2021                                                                                                                                                                                                                                                                                                                                                                                                   | 12                                                                                                                                                                                                                                                                                                                                                                                                     | 12                                                                                                                                                                                                                                                                                                                                                                                                     | 12                                                                                                                                                                                                                                                                                                                                                                                                     | 12                                                                                                                                                                                                                                                                                                                                                                                                     | 12                                                                                                                                                                                                                                                                                                                                                                                                     | 12                                                                                                                                                                                                                                                                                                                                                                                                     |
|  7 | Kerala        | 2022                                                                                                                                                                                                                                                                                                                                                                                                   | 2022                                                                                                                                                                                                                                                                                                                                                                                                   | 2022                                                                                                                                                                                                                                                                                                                                                                                                   | 2022                                                                                                                                                                                                                                                                                                                                                                                                   | 16                                                                                                                                                                                                                                                                                                                                                                                                     | 16                                                                                                                                                                                                                                                                                                                                                                                                     | 16                                                                                                                                                                                                                                                                                                                                                                                                     | 16                                                                                                                                                                                                                                                                                                                                                                                                     | 16                                                                                                                                                                                                                                                                                                                                                                                                     | 16                                                                                                                                                                                                                                                                                                                                                                                                     |
|  7 | Kerala        | 2023                                                                                                                                                                                                                                                                                                                                                                                                   | 2023                                                                                                                                                                                                                                                                                                                                                                                                   | 2023                                                                                                                                                                                                                                                                                                                                                                                                   | 2023                                                                                                                                                                                                                                                                                                                                                                                                   | 12                                                                                                                                                                                                                                                                                                                                                                                                     | 12                                                                                                                                                                                                                                                                                                                                                                                                     | 12                                                                                                                                                                                                                                                                                                                                                                                                     | 12                                                                                                                                                                                                                                                                                                                                                                                                     | 12                                                                                                                                                                                                                                                                                                                                                                                                     | 12                                                                                                                                                                                                                                                                                                                                                                                                     |
|  7 | Kerala        | Year                                                                                                                                                                                                                                                                                                                                                                                                   | Year                                                                                                                                                                                                                                                                                                                                                                                                   | Year                                                                                                                                                                                                                                                                                                                                                                                                   | Pending                                                                                                                                                                                                                                                                                                                                                                                                | Pending                                                                                                                                                                                                                                                                                                                                                                                                | Approved                                                                                                                                                                                                                                                                                                                                                                                               | Approved                                                                                                                                                                                                                                                                                                                                                                                               | Approved                                                                                                                                                                                                                                                                                                                                                                                               | Approved                                                                                                                                                                                                                                                                                                                                                                                               | Rejected                                                                                                                                                                                                                                                                                                                                                                                               |
|  7 | Kerala        | 2020                                                                                                                                                                                                                                                                                                                                                                                                   | 2020                                                                                                                                                                                                                                                                                                                                                                                                   | 2020                                                                                                                                                                                                                                                                                                                                                                                                   | 45                                                                                                                                                                                                                                                                                                                                                                                                     | 45                                                                                                                                                                                                                                                                                                                                                                                                     | 900 0                                                                                                                                                                                                                                                                                                                                                                                                  | 900 0                                                                                                                                                                                                                                                                                                                                                                                                  | 900 0                                                                                                                                                                                                                                                                                                                                                                                                  | 900 0                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                                                                                                                                                                                                        |
|  7 | Kerala        | 2021                                                                                                                                                                                                                                                                                                                                                                                                   | 2021                                                                                                                                                                                                                                                                                                                                                                                                   | 2021                                                                                                                                                                                                                                                                                                                                                                                                   | 60                                                                                                                                                                                                                                                                                                                                                                                                     | 60                                                                                                                                                                                                                                                                                                                                                                                                     | 1415 0                                                                                                                                                                                                                                                                                                                                                                                                 | 1415 0                                                                                                                                                                                                                                                                                                                                                                                                 | 1415 0                                                                                                                                                                                                                                                                                                                                                                                                 | 1415 0                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                        |
|  7 | Kerala        | 2022                                                                                                                                                                                                                                                                                                                                                                                                   | 2022                                                                                                                                                                                                                                                                                                                                                                                                   | 2022                                                                                                                                                                                                                                                                                                                                                                                                   | 75                                                                                                                                                                                                                                                                                                                                                                                                     | 75                                                                                                                                                                                                                                                                                                                                                                                                     | 1546 0                                                                                                                                                                                                                                                                                                                                                                                                 | 1546 0                                                                                                                                                                                                                                                                                                                                                                                                 | 1546 0                                                                                                                                                                                                                                                                                                                                                                                                 | 1546 0                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                        |
|  7 | Kerala        | Total                                                                                                                                                                                                                                                                                                                                                                                                  | Total                                                                                                                                                                                                                                                                                                                                                                                                  | Total                                                                                                                                                                                                                                                                                                                                                                                                  | 180                                                                                                                                                                                                                                                                                                                                                                                                    | 180                                                                                                                                                                                                                                                                                                                                                                                                    | 3861 0                                                                                                                                                                                                                                                                                                                                                                                                 | 3861 0                                                                                                                                                                                                                                                                                                                                                                                                 | 3861 0                                                                                                                                                                                                                                                                                                                                                                                                 | 3861 0                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                        |
|  8 | Maharashtra   | No applications for approval of indigenous medicines are pending during the last 03 years. The details of indigenous medicines approved, rejected and pending for approval is as follows -                                                                                                                                                                                                             | No applications for approval of indigenous medicines are pending during the last 03 years. The details of indigenous medicines approved, rejected and pending for approval is as follows -                                                                                                                                                                                                             | No applications for approval of indigenous medicines are pending during the last 03 years. The details of indigenous medicines approved, rejected and pending for approval is as follows -                                                                                                                                                                                                             | No applications for approval of indigenous medicines are pending during the last 03 years. The details of indigenous medicines approved, rejected and pending for approval is as follows -                                                                                                                                                                                                             | No applications for approval of indigenous medicines are pending during the last 03 years. The details of indigenous medicines approved, rejected and pending for approval is as follows -                                                                                                                                                                                                             | No applications for approval of indigenous medicines are pending during the last 03 years. The details of indigenous medicines approved, rejected and pending for approval is as follows -                                                                                                                                                                                                             | No applications for approval of indigenous medicines are pending during the last 03 years. The details of indigenous medicines approved, rejected and pending for approval is as follows -                                                                                                                                                                                                             | No applications for approval of indigenous medicines are pending during the last 03 years. The details of indigenous medicines approved, rejected and pending for approval is as follows -                                                                                                                                                                                                             | No applications for approval of indigenous medicines are pending during the last 03 years. The details of indigenous medicines approved, rejected and pending for approval is as follows -                                                                                                                                                                                                             | No applications for approval of indigenous medicines are pending during the last 03 years. The details of indigenous medicines approved, rejected and pending for approval is as follows -                                                                                                                                                                                                             |
|  8 | Maharashtra   | Period                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                        | 1 Jan 2020 to                                                                                                                                                                                                                                                                                                                                                                                          | 1 Jan 2020 to                                                                                                                                                                                                                                                                                                                                                                                          | 1 Jan 2021 to                                                                                                                                                                                                                                                                                                                                                                                          | 1 Jan 2021 to                                                                                                                                                                                                                                                                                                                                                                                          | 1 Jan 2022 to 1                                                                                                                                                                                                                                                                                                                                                                                        | 1 Jan 2022 to 1                                                                                                                                                                                                                                                                                                                                                                                        | 1 Jan 2022 to 1                                                                                                                                                                                                                                                                                                                                                                                        | Jan 2023 to 31 Dec 2023                                                                                                                                                                                                                                                                                                                                                                                |

|     |                   | Granted                                                                     | 9521                                                                        | 6967                                                                        | 6465                                                                        | 6979                                                                        |
|-----|-------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|
|     |                   | Rejected                                                                    | 636                                                                         | 506                                                                         | 435                                                                         | 354                                                                         |
|     |                   | Ongoing                                                                     | 0                                                                           | 0                                                                           | 1763                                                                        | 2295                                                                        |
| 9.  | Goa               | No applications are pending                                                 | No applications are pending                                                 | No applications are pending                                                 | No applications are pending                                                 | No applications are pending                                                 |
| 10. | Manipur           | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 11. | Ladakh            | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 12. | Jammu & Kashmir   | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 13. | Arunachal Pradesh | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 14. | Puducherry        | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 15. | Bihar             | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 16. | Chandigarh        | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 17. | Tripura           | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 18. | Lakshadweep       | UT of Lakshadweep does not have any manufacturing unit for Ayush medicines. | UT of Lakshadweep does not have any manufacturing unit for Ayush medicines. | UT of Lakshadweep does not have any manufacturing unit for Ayush medicines. | UT of Lakshadweep does not have any manufacturing unit for Ayush medicines. | UT of Lakshadweep does not have any manufacturing unit for Ayush medicines. |
| 19. | Chhattisgarh      | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 20. | Delhi             | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 21. | Mizoram West      |                                                                             |                                                                             | NIL                                                                         |                                                                             |                                                                             |
| 22. | Bengal            | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 23. | Himachal Pradesh  | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 24. | Jharkhand         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 25. | Haryana           | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |
| 26. | Gujarat           | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         | NIL                                                                         |

*******