Lok Sabha Question No. 4192 (UNSTARRED), answered on 2024-12-20
Subject: Export and Import of Ayurvedic Medicines
Ministry: AYUSH
Asked by: Smt. Manju Sharma

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 4192 TO BE ANSWERED ON 20 th  DECEMBER 2024

## ' Export and Import of Ayurvedic Medicines'

4192.  Smt. Manju Sharma:

Will the Minister of Ayush be pleased to state:

(a) the total number of Ayurvedic medicines exported and imported during the last three years, year-wise;

(b)  whether  the  Government  has  formulated  its  own  regulatory  framework/process  for Ayurvedic  medicines  as  per  international  standards  from  importing  countries  to  ensure safety  and  quality  of  Ayurvedic  medicines  and  to  increase  their  international  market demand;

(c) if so, the details thereof and if not, the reasons therefor;

(d) whether the Government proposes to set up a council/policy for development as well as export of Ayurvedic products and services across the world; and

(e) if so, the details thereof along with its composition and objectives?

## ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV)

(a)    No  such  data  is  maintained  by  Ministry  of  Ayush.  However,  as  per  Directorate General  of  Commercial  Intelligence  and  Statistics  (DGCIS)  data,  the  total  amount  of Ayurvedic  medicines  exported  and  imported  during  the  last  three  years,  year-wise  is available at Annexure-I.

(b) and (c) The Government has formulated following regulatory framework/process for Ayurvedic  medicines  as  per  international  standards  from  importing  countries  to  ensure safety  and  quality  of  Ayurvedic  medicines  and  to  increase  their  international  market demand:

i. Ministry of Ayush, Government of India has established Pharmacopoeia Commission for Indian  Medicine  and  Homoeopathy  (PCIM&H)  as  its  subordinate  office.  PCIM&H  on behalf of Ministry of Ayush lays down the formulary specifications and pharmacopoeial standards for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs which serves as  official  compendia  for  ascertaining  the  quality    (identity,  purity  and  strength)  of  the ASU&H  drugs.  As  per  the  Drugs  &  Cosmetics  Act,  1940  and  rules  thereunder,  the compliance to this quality standards are mandatory for the production of ASU&H drugs being  manufactured,  sold,  stocked  or  exhibited  in  India.  The  standards  and  quality parameters included in the Pharmacopoeias and Formularies of ASU&H drugs prescribing mandatory regulatory standards have been identified to align the parameters prescribed by World  Health  Organisation  (WHO)/other  major  pharmacopoeias  prevalent  worldwide. Implementation of these pharmacopoeial standards ensures that the medicines reaching to masses  inland  as  well  as  globally  conform  to  optimum  quality  standards  in  terms  of identity, purity and strength. So far, 2259 quality standards on raw materials (Single drugs of  plant/  animal/  mineral/  metal/  chemical  origin)  used  in  ASU&H  drugs,  405  quality standards of ASU formulations and 2666 formulary specifications of ASU drugs has been published. In addition to above, supporting documents in the form of Macro-Microscopic & TLC Atlas on 351 single drugs incorporated in Ayurvedic Pharmacopoeia of India (API) have  also  been  published.  PCIM&H  also  acts  as  appellate  drug  testing  laboratory  to receive the samples from Govt. agencies as per the Drugs & Cosmetics Act, 1940 and rules made thereunder for ascertaining their quality.

PCIM&H has taken up the task to harmonize all the monographs published/being published  through  Ayurvedic  Pharmacopoeia  of  India  (API),  Siddha  Pharmacopoeia  of India (SPI), Unani Pharmacopoeia of India (UPI), Homoeopathic Pharmacopoeia of India (HPI) and Indian Pharmacopoeia (IP). PCIM&H and Indian Pharmacopoeia Commission (IPC)  have  signed  a  MoU  for  developing  "One  Herb-One  Standard",  each  monograph published through this collaboration will have  Indian Standards along with  International quality  requirements,  so  that  all  Indian  standards  become  contemporary  with  global standards.

ii. In 2021, Ministry of Ayush has implemented Central Sector Scheme, Ayush Oushadhi Gunvatta  Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY)  and  the  total  financial allocation to this scheme is Rs.122.00 crores for 05 years. The components of AOGUSY scheme are as follows -

- A. Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards.
- B. Pharmacovigilance of ASU&H  drugs including surveillance of misleading advertisements.
- C. Strengthening  of  Central  and  State  regulatory  frameworks  including  Technical Human Resource & Capacity Building programs for Ayush drugs.
- D. 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.

iii.  Further,  for  facilitating  exports  of  Ayush  products,  Ministry  of  Ayush  encourages following certifications of Ayush products as per details below:

-  The  scheme  for  Certification  of  Pharmaceutical  Product  (CoPP)  as  per World  Health  Organization  (WHO)  guidelines  is  extended  to  Ayurveda,  Siddha and  Unani  (ASU)  medicines.  This  scheme  is  administered  by  Central  Drugs Standard Control Organization (CDSCO) and the certificate is granted on the basis of  joint  inspection  of  the  applicant  manufacturing  unit  by  the  representatives  of CDSCO, Ministry of Ayush and the concerned State Licensing Authority.
-  Quality Certification Schemes implemented by the Quality Council of India (QCI) for grant of Ayush Premium mark to Ayurveda, Siddha and Unani products on  the  basis  of  third  party  evaluation  of  quality  in  accordance  with  the  status  of compliance to international standards.

(d) and (e) Ayush Export Promotion Council (AYUSHEXCIL), is a newly formed Export Promotion Council (set up by Ministry of Ayush and supported by Ministry of Commerce, Government of India), launched at Global Ayush Investment and Innovation Summit held in Gandhinagar, Gujarat on April 20, 2022).  It is aimed to oversee exports of products of Ayurveda, Homoeopathy, Siddha, Sowa Rigpa and Unani systems and address trade issues pertaining to these sectors. It mandates to facilitate capacity building of its members on export  procedures,  organize  business  to  business  meetings,  international  events,  road shows,  seminars  and  workshops  on  the  export  of  Ayush  products  and  to  safeguard  the scientific research in the field of Ayush healthcare.

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## Annexure I

As per Directorate General of Commercial Intelligence and Statistics (DGCIS) data, the total amount of Ayurvedic medicines exported and imported during the last three years, year-wise is as below:

## Export details:

| HS Code   | Commodity                       | 2021-22 Value (US $)   | 2022-23 Value (US $)   | 2023-24 Value (US $)   |
|-----------|---------------------------------|------------------------|------------------------|------------------------|
| 30039011  | Medicants of Ayurvedic system   | 1,36,23,321            | 1,40,89,391            | 1,24,97,813            |
| 30049011  | Medicaments of Ayurvedic system | 17,35,53,933           | 17,75,43,788           | 16,23,83,335           |
| Total     |                                 | 18,71,77,254           | 19,16,33,179           | 17,48,81,148           |

## Import details:

| HS Code   | Commodity                       | 2021-22 Value(US $)   | 2022-23 Value(US $)   | 2023-24 Value(US $)   |
|-----------|---------------------------------|-----------------------|-----------------------|-----------------------|
| 30039011  | Medicants of Ayurvedic system   | 1,29,74,950           | 1,15,85,655           | 99,91,795             |
| 30049011  | Medicaments of Ayurvedic system | 20,96,846             | 24,57,447             | 26,42,360             |
| Total     |                                 | 1,50,71,796           | 1,40,43,102           | 1,26,34,155           |

Source:  Directorate  General  of  Commercial  Intelligence  and  Statistics  (DGCIS)  data  @ https://ftddp.dgciskol.gov.in/dgcis/userindex.html#!/pcgroupsearch

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