Lok Sabha Question No. 3043 (UNSTARRED), answered on 2024-08-09
Subject: Quality AYUSH Medicines
Ministry: AYUSH
Asked by: Shri Navaskani K, Shri Selvam G, Dr. Thirumaavalavan Tholkappiyan, Shri C N Annadurai, Dr. D Ravi Kumar

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 3043 TO BE ANSWERED ON 09 th  AUGUST 2024

'Quality AYUSH Medicines'

3043. Shri Navaskani K:

Dr. Thirumaavalavan Tholkappiyan:

Dr. D Ravi Kumar:

Shri C N Annadurai:

Shri Selvam G:

Will the Minister of AYUSH be pleased to state:

(a)  whether  the  Government  has  taken  steps  to  provide  quality  AYUSH  medicines ataffordable rates in the country and if so, the details thereof;

(b) whether there is a steep increase in the prices of AYUSH medicines in recent times and if so, the details and reasons thereof and the corrective steps taken/proposed to be taken in this

regard;

(c) whether any measures to ensure availability of Ayurveda medicines through Jan Aushadhi outlets are under consideration of the Government and if so, the details thereof;

(d)  whether the Government has also taken any stringent measures to control and curb the sale of spurious Ayurvedic and Unani medicines in the country and if so, the details thereof;

and

(e) the details of the number of cases lodged against the sale and distribution of spurious medicines, State/UT-wise and year-wise during the last three years?

## ANSWER

THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH

(SHRI PRATAP RAO JADHAV)

(a)  and  (c)  Under  Rule  158  B  of  Drugs  &  Cosmetics  Rules,  1945,  guidelines  for  issue  of license    and  requirement  of  safety  study  and  Experience/Evidence  of  effectiveness  with

respect  to  Ayurveda,  Siddha  or  Unani  drugs  has  been  prescribed.  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 and Schedule M-I of Drugs and Cosmetics Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

At  present  5  selected  Ayurvedic  products  have  been  added  in  the  product  basket  of Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), which are being made available through selected Kendras at affordable rates.

(b) No study has been conducted regarding the price of Ayush medicines.

(d)  and  (e)  Yes  sir.  The  Drugs  &  Cosmetics  Act,  1940  and  Rules  made  there  under  have exclusive  regulatory  provisions  for  Ayurvedic,  Siddha,  Unani,  and  Homoeopathy  drugs. Provisions  related  to  spurious  Ayurveda,  Siddha  and  Unani  drugs  are  prescribed  under Section 33EEA and penalty for manufacture for sale or for distribution of any such drugs are prescribed under section 33 I of Drugs and Cosmetics Act, 1940.  Further, Rule 159 of Drugs and Cosmetics Rules, 1945 have provisions for cancellation or suspension of licences if the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Drugs and Cosmetics Act, 1940 or the rules made thereunder.

As prescribed in  Drugs  and  Cosmetics  Act  1940  and  Rules  1945  made  thereunder, enforcement of the legal provisions pertaining to Quality Control and issuance of drug license of  Ayurveda,  Siddha  and  Unani  drugs,  is  vested  with  the  State  Drug  Controllers/State Licensing Authorities appointed by the concerned State/ Union Territory Government.

As  per  the  information  received  from  States/  UTs  governments,  details  of  the  number  of cases lodged against the sale and distribution of spuriousmedicines, State/UT-wise and yearwise during the last three are as follows:

| S.no.   | Name of the State/ UT    | Details          | Details                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Details                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Details                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Details                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Details                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|---------|--------------------------|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.      | Gujarat                  | 2021- NIL 2022   | 2021- NIL 2022                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 2021- NIL 2022                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 2021- NIL 2022                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 2021- NIL 2022                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 2021- NIL 2022                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |
| 1.      | Gujarat                  | S.No             | Product Mfg. Reason Action                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Product Mfg. Reason Action                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Product Mfg. Reason Action                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Product Mfg. Reason Action                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Product Mfg. Reason Action                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| 1.      | Gujarat                  |                  | Name taken TulsiSantraAshv a herbal tonic Tulshi Ayurveda, Rajkot The sample contains 13.38 percent v/v ethyl alcohol/Sp urious Court case launched court case no. 2054/2022 , Dated- 09/12/202 2 Prashovan Tablets Relabeling PareshHari lalChovati ya Relabeling /Spurious Court case launched court case no. 21356/202 2, Dated- 01/09/202 2 2023 New Orthonil Powder Babaji Herbals Punjab Presence of prednisolo ne in Ayurvedic product Court case launched court case no. 22173/202 3, Dated- 28/08/202 3 2024- NIL cases booked for last three years. However the product suspension/cancellation against the sale and distribution of | Name taken TulsiSantraAshv a herbal tonic Tulshi Ayurveda, Rajkot The sample contains 13.38 percent v/v ethyl alcohol/Sp urious Court case launched court case no. 2054/2022 , Dated- 09/12/202 2 Prashovan Tablets Relabeling PareshHari lalChovati ya Relabeling /Spurious Court case launched court case no. 21356/202 2, Dated- 01/09/202 2 2023 New Orthonil Powder Babaji Herbals Punjab Presence of prednisolo ne in Ayurvedic product Court case launched court case no. 22173/202 3, Dated- 28/08/202 3 2024- NIL cases booked for last three years. However the product suspension/cancellation against the sale and distribution of | Name taken TulsiSantraAshv a herbal tonic Tulshi Ayurveda, Rajkot The sample contains 13.38 percent v/v ethyl alcohol/Sp urious Court case launched court case no. 2054/2022 , Dated- 09/12/202 2 Prashovan Tablets Relabeling PareshHari lalChovati ya Relabeling /Spurious Court case launched court case no. 21356/202 2, Dated- 01/09/202 2 2023 New Orthonil Powder Babaji Herbals Punjab Presence of prednisolo ne in Ayurvedic product Court case launched court case no. 22173/202 3, Dated- 28/08/202 3 2024- NIL cases booked for last three years. However the product suspension/cancellation against the sale and distribution of | Name taken TulsiSantraAshv a herbal tonic Tulshi Ayurveda, Rajkot The sample contains 13.38 percent v/v ethyl alcohol/Sp urious Court case launched court case no. 2054/2022 , Dated- 09/12/202 2 Prashovan Tablets Relabeling PareshHari lalChovati ya Relabeling /Spurious Court case launched court case no. 21356/202 2, Dated- 01/09/202 2 2023 New Orthonil Powder Babaji Herbals Punjab Presence of prednisolo ne in Ayurvedic product Court case launched court case no. 22173/202 3, Dated- 28/08/202 3 2024- NIL cases booked for last three years. However the product suspension/cancellation against the sale and distribution of | Name taken TulsiSantraAshv a herbal tonic Tulshi Ayurveda, Rajkot The sample contains 13.38 percent v/v ethyl alcohol/Sp urious Court case launched court case no. 2054/2022 , Dated- 09/12/202 2 Prashovan Tablets Relabeling PareshHari lalChovati ya Relabeling /Spurious Court case launched court case no. 21356/202 2, Dated- 01/09/202 2 2023 New Orthonil Powder Babaji Herbals Punjab Presence of prednisolo ne in Ayurvedic product Court case launched court case no. 22173/202 3, Dated- 28/08/202 3 2024- NIL cases booked for last three years. However the product suspension/cancellation against the sale and distribution of |
| 1.      | Maharashtra              | Period of Action |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
| 2. 3.   | Tamil Nadu  No spurious | were taken       | medicines No. samples                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | three years.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | for last                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | prosecution.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
| 2. 3.   |                          | REPL Renovision  | 17 28-09-2022                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | consent letter Export                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Status Persecution                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
| 2. 3.   |                          | 2021 2022        | 23                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | Issued consent letter for Issued for prosecution.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | firm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
| 2. 3.   |                          | 2023             | 02                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | Issued consent letter for prosecution. for prosecution.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
| 4.      | Jharkhand Date           | 2024 Drug        | 12                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | Issued consent letter                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | Manufacturing                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |

|    |                   |                                                                                                                                                                        | Orthovit Capsule                                                                                                                                                       | Pvt Ltd Unit II, Karnidih, P.O. Chilgu, PS: Chandil, Kharsawan- 832401.                                                                                                | filed.                                                                                                                                                                 |
|----|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|  5 | Goa               |  No such cases has been launched for sale and distribution of spurious Ayurvedic medicines for sale 3 years by this Directorate.                                      |  No such cases has been launched for sale and distribution of spurious Ayurvedic medicines for sale 3 years by this Directorate.                                      |  No such cases has been launched for sale and distribution of spurious Ayurvedic medicines for sale 3 years by this Directorate.                                      |  No such cases has been launched for sale and distribution of spurious Ayurvedic medicines for sale 3 years by this Directorate.                                      |
|  6 | Mizoram           |  Mizoram does not have any cases booked against the sale and distribution of spurious Ayush medicines.                                                                |  Mizoram does not have any cases booked against the sale and distribution of spurious Ayush medicines.                                                                |  Mizoram does not have any cases booked against the sale and distribution of spurious Ayush medicines.                                                                |  Mizoram does not have any cases booked against the sale and distribution of spurious Ayush medicines.                                                                |
|  7 | Odisha            |  No such cases of spurious drugs have come to notice during the last three years.                                                                                     |  No such cases of spurious drugs have come to notice during the last three years.                                                                                     |  No such cases of spurious drugs have come to notice during the last three years.                                                                                     |  No such cases of spurious drugs have come to notice during the last three years.                                                                                     |
|  8 | J&K               |  In the UT of J&K the monitoring of Ayush companies for selling any spurious Ayurveda and Unani drugs in being looks after by Drug and Food Control Organization J&K. |  In the UT of J&K the monitoring of Ayush companies for selling any spurious Ayurveda and Unani drugs in being looks after by Drug and Food Control Organization J&K. |  In the UT of J&K the monitoring of Ayush companies for selling any spurious Ayurveda and Unani drugs in being looks after by Drug and Food Control Organization J&K. |  In the UT of J&K the monitoring of Ayush companies for selling any spurious Ayurveda and Unani drugs in being looks after by Drug and Food Control Organization J&K. |
|  9 | Andhra Pradesh    |  Notices have been issued.                                                                                                                                            |  Notices have been issued.                                                                                                                                            |  Notices have been issued.                                                                                                                                            |  Notices have been issued.                                                                                                                                            |
| 10 | Andaman Nicobar   |  No such case of sale and distribution of spurious medicines have been reported to the UT Administration during last three years.                                     |  No such case of sale and distribution of spurious medicines have been reported to the UT Administration during last three years.                                     |  No such case of sale and distribution of spurious medicines have been reported to the UT Administration during last three years.                                     |  No such case of sale and distribution of spurious medicines have been reported to the UT Administration during last three years.                                     |
| 11 | Manipur           |  No such cases found in the state.                                                                                                                                    |  No such cases found in the state.                                                                                                                                    |  No such cases found in the state.                                                                                                                                    |  No such cases found in the state.                                                                                                                                    |
| 12 | Karnataka         |  No such cases reported in the state of Karnataka.                                                                                                                    |  No such cases reported in the state of Karnataka.                                                                                                                    |  No such cases reported in the state of Karnataka.                                                                                                                    |  No such cases reported in the state of Karnataka.                                                                                                                    |
| 13 | Madhya Pradesh    |  No complaint received regarding spurious medicines.                                                                                                                  |  No complaint received regarding spurious medicines.                                                                                                                  |  No complaint received regarding spurious medicines.                                                                                                                  |  No complaint received regarding spurious medicines.                                                                                                                  |
| 14 | Himachal Pradesh  | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       |
| 15 | Delhi             | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       |
| 16 | Chhattisgarh      | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       |
| 17 | Uttar Pradesh     | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       |
| 18 | Ladakh            | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       |
| 19 | Puducherry        | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       | NIL Information.                                                                                                                                                       |
| 20 | Arunachal Pradesh | NIL Information                                                                                                                                                        | NIL Information                                                                                                                                                        | NIL Information                                                                                                                                                        | NIL Information                                                                                                                                                        |
| 21 | Lakshadweep       | NIL Information                                                                                                                                                        | NIL Information                                                                                                                                                        | NIL Information                                                                                                                                                        | NIL Information                                                                                                                                                        |
| 22 | Tripura           | NIL Information                                                                                                                                                        | NIL Information                                                                                                                                                        | NIL Information                                                                                                                                                        | NIL Information                                                                                                                                                        |

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