Lok Sabha Question No. 3506 (UNSTARRED), answered on 2025-03-21
Subject: Export of Traditional Medicines and Health Products
Ministry: AYUSH
Asked by: Dr. Sambit Patra

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 3506 TO BE ANSWERED ON 21 st  March 2025

## 'Export of Traditional Medicines and Health Products'

## 3506. Dr. Sambit Patra:

Will the Minister of Ayush be pleased to state:

- (a) the details of the targets set by the Government under AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana and the achievements made thereunder during the last five years;
- (b) whether  the  Government  has  implemented  any  action  plan  to  enhance  the  export  of traditional medicines and healthcare products through Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana and if so, the details thereof;
- (c) whether  the  Government  has  set  any  targets  for  export  of  traditional  medicines  and healthcare products through Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana;
- (d) if so, the details of the targets set and achievements made thereunder during the last three years;
- (e) whether  the  Government  has  taken  any  measures  for  effective  quality  control,  safety monitoring and surveillance of misleading advertisements of AYUSH medicines; and
- (f) if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAOJADHAV)

(a) In  the  year  2021,  Ministry  of  Ayush  has  implemented  a  Central  Sector  Scheme-  Ayush Oushadhi  Gunavatta  Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY),  the  total  Budget

allocation  to  this  scheme  is  Rs.  122.00  Crores  for  five  years.  The  components  of  AOGUSY scheme are as follows:

1. Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards.
2. Pharmacovigilance of ASU&H drugs including surveillance of misleading advertisements.
3. Strengthening  of  Central  and  State  regulatory  frameworks  including  Technical  Human Resource & Capacity Building programs for Ayush drugs.
4. Support for development of standards and accreditation/certification of Ayush products & materials  in  collaboration  with  Bureau  of  Indian  Standards  (BIS),  Quality  Control  of India (QCI) and other relevant scientific institutions and industrial R&D centres.

The  first  component  of  the  Scheme  is  Strengthening  and  up-gradation  of  Ayush Pharmacies  and  Drug  Testing  Laboratories  to  achieve  higher  standards.  This  component  is intended  to  increase  the  standards  of  Ayurveda,  Siddha,  Unani  and  Homoeopathy(ASU&H) Pharmacies and Drug Testing Laboratories (DTL) to World Health Organisation(WHO)- Good Manufacturing  Practices(GMP)  and  National  Accreditation  Board  for  Testing  and  Calibration Laboratories(NABL)  levels,  respectively.  Till  date,  20  ASU&H  pharmacies  and  12  ASU&H drug testing laboratories have been supported financially under this scheme.

The  second  component  of  the  Scheme  deals  with  Pharmacovigilance  Program  for ASU&H Drugs, working through a three-tier network of a National Pharmacovigilance Centre (NPvCC), 5 Intermediary Pharmacovigilance Centers (IPvCs) and 99 Peripheral Pharmacovigilance Centers (PPvCs) across the country. In this regard, during the last five years (till  February  2025),  a  total  of  35928  misleading  advertisements  related  to  Ayush  drugs  have been  identified,  which  are  reported  to  the  respective  State  Regulatory  Authorities  for  suitable action against the defaulter(s). Also, the program is regularly reporting Suspected Adverse Drug Reactions for ASU&H drugs, wherein 1762 such suspected signals have been reported till date. Further, towards sensitizing various healthcare professional cohorts, 2324 awareness programs have been conducted with 213673 beneficiaries.

Under  the  third  component  of  the  Scheme-  Strengthening  of  Central  and  State regulatory frameworks including Technical Human Resource & Capacity Building programs for Ayush  drugs,  three  training  programmes  have  been  conducted  for  Ayush  drug  regulators,

industry personnel and other stake holders in the different zones of the country, which are South Zone, North-Eastern states and Central Zone, till date.

(b) to (d) The action plan implemented by the Government to enhance the export of traditional medicines and healthcare products through Ayush Oushadhi Gunvatta Evam  Uttpadan Samvardhan Yojana(AOGUSY) is as  follows:-

The  first  component  of  the  Scheme-  Strengthening  and  up-gradation  of  Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards is intended to increase the standards of ASU&H Pharmacies and DTLs to WHO-GMP and NABL levels respectively. The funding pattern details are as follows-

1. The State Govt./U.T.'s ASU&H Pharmacies/State Govt. ASU&H Cooperatives, State Govt. ASU&H PSUs are funded up to Rs. 6.00 crore for strengthening infrastructure & technology up-gradation  and  meeting  associated  recurring  costs  for  upgrading  pharmacy  in  terms  of technology used and quantum of production whereas, the Private ASU&H Pharmacies are supported with 50% of the project cost limited to Rs. 3.00 crore for equipment, machinery and scientific instruments to achieve higher standards of GMP (like WHO-GMP, cGMP, EUGMP) for obtaining WHO-GMP certification within 2 and 1/2 years from the date of first disbursement of Grant-in-Aid.
2. The  State/U.T.  Govt  ASU&H  Drug  Testing  Laboratories,  Government  and  Research Councils  laboratories  are  funded upto  Rs.  3.00  crore  for  strengthening  infrastructure  & technology  up-gradation  to  acquire  NABL  accreditation  and  meeting  recurring  costs  of chemicals & reagents, consumables and technical manpower whereas, the Private ASU&H Drug  Testing  Laboratories/in  house  Quality  Control  Lab  of  GMP  certified  ASU&H manufacturing units are supported with 50% of the project cost limited to Rs. 1.50 crore for acquiring scientific  equipment and instruments for NABL accreditation,  in order to follow NABL Guidelines & get accredited as 'NABL' in stipulated time-frame.

Till date, 20 ASU & H pharmacies and 12 ASU&H drug testing laboratories have been supported financially. Further, for release of Grand-in-aid All India Institute of Ayurveda, New Delhi, AIIA is designated as Central Nodal Agency. The details of Grant-in-Aid are annexed as Annexure-I.

(e)  and  (f) Yes,  the  measures  taken  for  effective  quality  control,  safety  monitoring  and surveillance of misleading advertisements of Ayush medicines are as follows;

1. As prescribed in Drugs and Cosmetics Act 1940 and Rules made thereunder, enforcement of the  legal  provisions  pertaining  to  Quality  Control  and  issuance  of  drug  license  of  Ayurveda, Siddha, Unani and Homoeopathy drugs, is vested with the State Drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government. Rule 158-B in the Drugs  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 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 the Drugs Rules, 1945 and quality  standards  of  drugs  given  in  the  respective  pharmacopoeia.  Drug  Inspectors  collect medicine  samples  regularly  from  industries  and  Markets  and  sent  it  to  State  Drug  Testing Laboratory  for  quality  testing  and  take  further  necessary  action(s)  on  the  basis  of  such  tests reports as per Drugs and Cosmetics Act 1940 and Rules made thereunder .

2.  Pharmacopoeia  Commission  for  Indian  Medicine  &  Homoeopathy(PCIM&H)  on  behalf  of Ministry  of  Ayush  lays  down  the  Formulary  specifications  and  Pharmacopoeial  Standards  for ASU&H drugs, which serve as official compendia for ascertaining the Quality Control (identity, purity and strength) of the ASU&H drugs, included herein, as per Drugs & Cosmetics Act, 1940 and Rules 1945 and compliance to these quality standards are mandatory for manufacturing, sale and stock of ASU&H drugs in India. The quality parameters included in the Pharmacopoeias and Formularies of Ayurveda, Siddha, Unani &  Homoeopathic  (ASU&H)  drugs  prescribing mandatory  regulatory  standards  have  been  identified  to  align  the  parameters  prescribed  by WHO/other major pharmacopoeias prevalent worldwide. Implementation of these pharmacopoeial  standards  ensures  optimum  quality  standards  in  terms  of  identity,  purity  and strength of ASU&H drugs.

3.  The  Pharmacovigilance  Program  for  ASU  &  H  Drugs  has  been  implemented  under  Central Sector  Scheme  Ayush  Oushadhi  Gunavatta  Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY), which work through a three-tier network of a National Pharmacovigilance Centre (NPvCC), Five Intermediary  Pharmacovigilance  Centers  (IPvCs)  and  99  Peripheral  Pharmacovigilance  Centers

(PPvCs) established across the country. All India Institute of Ayurveda (AIIA), New Delhi under Ministry  of  Ayush  is  the  National  Pharmacovigilance  Co-ordination  Centre  (NPvCC)  for  the implementation  of  the  National  Pharmacovigilance  program  for  Ayurveda,  Siddha,  Unani  & Homoeopathy  drugs.  These  centres  are  mandated  to monitor and report the misleading advertisements to the respective State Regulatory Authorities for suitable action against the defaulter(s).  Under  the  Pharmacovigilance  program,  as  of  February  2025,  a  total  of 35928 misleading advertisements related to Ayush drugs have been identified. Also, the program is regularly reporting Suspected Adverse Drug Reactions for ASU &H drugs, wherein 1762 such suspected  signals  have  been  reported  till  date.  Further,  towards  sensitizing  various  healthcare professional cohorts, 2324 awareness programs have been conducted with 213673 beneficiaries. Details are annexed as Annexure II.

*****

## Details of Funds Released under AOGUSY Central Sector Scheme

| S. No.    | F.Y.           | State                                                                                                        | Component   | Pharmacy/ DTL                                                                       | Particulars                                  | Amount released   |
|-----------|----------------|--------------------------------------------------------------------------------------------------------------|-------------|-------------------------------------------------------------------------------------|----------------------------------------------|-------------------|
| 1 2021-22 | Mizoram        | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards |             | DTL                                                                                 | State Govt. of Mizoram                       | Rs. 1,800,000     |
| 2022-23   | Pune           | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards |             | Pharmacy                                                                            | Inducare Pharma Pvt.Ltd. Pune Rs. 30,000,000 | 2                 |
| 3         | Maharashtra    | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards |             | Pharmacy                                                                            | Ayurchem Private Ltd. Maharashtra.           | Rs. 26,900,000    |
| 4         | Maharashtra    | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy    | Phytovedic India Pvt. Ltd. Maharashtra                                              | Rs. 21,461,000                               |                   |
| 5         | Kerala         | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy    | Visesh Ayurvedic Pvt. Ltd Pharmacy Kerala.                                          | Rs. 19,156,000                               |                   |
| 6         | Uttar Pradesh  | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy    | Amar Pharmaceuticals and labs (I) Pvt. Ltd. U.P                                     | Rs. 14,343,000                               |                   |
| 7         | Uttar Pradesh  | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL         | Amar Pharmaceuticals and labs (I) Pvt. Ltd. U.P (DTL)                               | Rs. 7,767,000                                |                   |
| 8         | Madhya Pradesh | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy    | Shree Baidyanath Ayurved Bhawan Pvt. Ltd, Madhya Pradesh                            | Rs. 20,892,000                               |                   |
| 2022-23   | Kerala         | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy    | Kollam District Ayurveda Oushdha Nirmana Vyavasaya Co-operative Society Ltd, Kerela | Rs. 6,429,000                                | 9                 |
| 2023-24   | Tripura        | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL         | State Govt. of Tripura                                                              | Rs. 7,668,000                                | 10                |

## Annexure-I

| 11      | Madhya            | Pradesh                                                                                                      | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | Pharmacy                                                         | Shree Baidyanath Ayurved Bhawan Pvt. Ltd, Madhya Pradesh   |   Rs. 9,108,000 |
|---------|-------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------|-----------------|
|         | Jammu& Kashmir    | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL                                                                                                            | State Govt. J&K                                                  | Rs. 8,629,500                                              |              12 |
|         | Kerala            | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy                                                                                                       | Sitaram Ayurveda Pvt. Ltd, Thrissur, Kerala.                     | Rs. 5,000,000                                              |              13 |
|         | Kerala            | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy                                                                                                       | Pankajakasthuri Herbals India Private Limited, Poovachal, Kerala | Rs. 5,000,000                                              |              14 |
|         | Rajasthan         | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy                                                                                                       | BJain Pharmaceuticals Private Limited, Alwar, Rajasthan          | Rs. 5,000,000                                              |              15 |
|         | Assam             | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy                                                                                                       | Assam Ayurvedic Products, Guwahati, Assam (PSU)                  | Rs. 4,559,519                                              |              16 |
|         | Jammu& Kashmir    | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy                                                                                                       | Govt. Pharmacy, Jammu &Kashmir                                   | Rs. 10,500,000                                             |              17 |
|         | Gujarat           | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy                                                                                                       | State Pharmacy, Rajpipla, Gujarat                                | Rs. 4,420,248                                              |              18 |
|         | Mizoram           | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL                                                                                                            | State Govt. Drug Testing Laboratory, Mizoram                     | Rs. 6,720,884                                              |              19 |
|         | Tamil Nadu        | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL                                                                                                            | State Govt. Drug Testing Laboratory, Tamil Nadu                  | Rs. 2,000,000                                              |              20 |
|         | Arunachal Pradesh | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy                                                                                                       | State Pharmacy, Arunachal Pradesh                                | Rs. 6,702,164                                              |              21 |
|         | Arunachal Pradesh | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL                                                                                                            | State Drug Testing Laboratory , Arunachal Pradesh                | Rs. 1,799,813                                              |              22 |
| 2024-25 | Arunachal Pradesh | Strengthening and up-gradation of Ayush Pharmacies                                                           | Pharmacy                                                                                                       | State Pharmacy, Arunachal Pradesh                                | Rs. 7,042,077                                              |              23 |

| 24   | Arunachal Pradesh   | and Drug Testing Laboratories to achieve higher standards                                                    | DTL      | State Drug Testing Laboratory , Arunachal Pradesh                                                                 | Rs. 1,724,400   |
|------|---------------------|--------------------------------------------------------------------------------------------------------------|----------|-------------------------------------------------------------------------------------------------------------------|-----------------|
| 24   | Kerala              | and Drug Testing Laboratories to achieve higher standards                                                    | Pharmacy | Pankajakasthuri Herbals India Private Limited, Poovachal, Kerala                                                  | Rs. 4,432,807   |
| 24   | Tamil Nadu          | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL      | State Govt. Drug Testing Laboratory, Tamil Nadu                                                                   | Rs. 5,100,000   |
| 24   | Rajasthan           | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy | BJain Pharmaceuticals Private Limited, Alwar, Rajasthan                                                           | Rs. 14,454,189  |
| 24   | Mizoram             | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL      | State Govt. Drug Testing Laboratory, Mizoram                                                                      | Rs. 3,940,500   |
| 24   | Tamil Nadu          | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL      | State Govt. Drug Testing Laboratory, Tamil Nadu                                                                   | Rs. 4,157,062   |
| 24   | Gujarat             | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy | State Pharmacy, Rajpipla, Gujarat                                                                                 | Rs. 20,000,000  |
| 24   | Mizoram             | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL      | State Govt. Drug Testing Laboratory, Mizoram                                                                      | Rs. 1,800,000   |
| 24   | Tamil Nadu          | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy | State Govt. Pharmacy, Tamil Nadu Medicinal Plant Farms &Herbal Medicine Corporation Limited (TAMPCOL), Tamil Nadu | Rs. 4,500,000   |
|      |                     |                                                                                                              |          | Total                                                                                                             | Rs. 293,007,163 |

| Year            | Misleading Advertisements   |   Suspected ADR's |
|-----------------|-----------------------------|-------------------|
| 2021            | 8144 + 43 (COVID)           |               360 |
| 2022            | 7367 + 4 (COVID)            |               324 |
| 2023            | 7771                        |               420 |
| 2024            | 10161                       |               521 |
| 2025 (Feb 2025) | 2438                        |               137 |
| Total           | 35928                       |              1762 |

| Year            |   Awareness Program |   Beneficiaries |
|-----------------|---------------------|-----------------|
| 2021            |                 118 |           14659 |
| 2022            |                 292 |           23510 |
| 2023            |                 586 |           43396 |
| 2024            |                1065 |          105148 |
| 2025 (Feb 2025) |                 263 |           26960 |
| Total           |                2324 |          213673 |

## Annexure -II