Lok Sabha Question No. 3063 (UNSTARRED), answered on 2024-08-09
Subject: Progress in AYUSH Sector
Ministry: AYUSH
Asked by: Shri Imran Masood

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 3063 TO BE ANSWERED ON 09 th  AUGUST, 2024

## 'Progress in AYUSH Sector'

3063 Shri Imran Masood:

Will the Minister of AYUSH be pleased to state:

(a) the details of the progress made in the AYUSH sector during the last five years, yearwise;

(b) whether there is a shortage of Ayush raw materials due to the excessive dependency on forest produce and if so, the details thereof;

(c)  the  steps  taken  by  the  Government  to  overcome  the  shortage  of  AYUSH  raw materials; and

(d) whether there is any concrete strategy to make the regulatory system in the AYUSH sector more effective and if so, the details thereof?

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

(a)    Ministry  of  Ayush  has  published  a  report  entitled  'A  Decade  of  Transformative Growth in Ayush, 2014-2024'. Details are available at https://ayush.gov.in/ images/annualReport/  DecadeAyushReport.pdf. Year-wise details  of the progress  made in the AYUSH sector during the last five years are as follows -

## i. Budget of Ministry of Ayush

During  the  last  five  years,  budget  allocation  to  Ministry  of  Ayush  has  been increased which reflects a growing recognition of the importance of the sector. Year wise details of budget allocated to Ministry of Ayush are at Annexure-I.

## ii. Ayush Infrastructure

Total Number of Ayush Hospitals, Beds, Dispensaries and Registered Practitioners (Doctors) the countries during the years 2018-2022 are at Annexure-I.

## iii. Ayush  drug industry

As  per  the  Research  and  Information  System  for  Developing  Countries  (RIS) report  of 2020, the Ayush manufacturing industry size has been estimated at Rs.1,37,800 crores (USD 18.1 Bn) that is 6 times rise in 7 years. Similarly, preliminary study of RIS shows Rs 1,66,797 Crores  Revenue  in  Ayush  Service  sector.  Total  number  of    Ayush manufacturing  units  in  the  country  during  the  years  2018-2022  (as  reported  by  State Governments/ Concerned Agencies)  are  at Annexure-I.

Indian Medicines Pharmaceutical Corporation Limited (IMPCL) is a central public sector  undertaking  under  Ministry  of  Ayush,  which  is  engaged  in  manufacturing  of Ayurveda and Unani medicines in Ayush Sector. Turnover of IMPCL during past five years is at Annexure-I.

## iv. Education

National  Commission  for  Indian  System  of  Medicine  (NCISM)  Act  2020  and National  Commission  for  Homoeopathy  (NCH)  Act  2020  were  enacted  in  September 2020.  These  acts  replaced  the  old  Indian  Medicine  Central  Council  Act  1970  and Homoeopathy  Central  Council  Act  1973  respectively.  Year-wise  details  of  Ayush colleges increased/ established in last five years are at Annexure-II.

## v. Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H)

Government  of  India  has  established  Pharmacopoeia  Commission  for  Indian Medicine & Homoeopathy (PCIM&H) as its subordinate office by merging Pharmacopoeial Laboratory for Indian Medicine (PLIM), Ghaziabad and Homoeopathic Pharmacopoeia Laboratory (HPL), Ghaziabad, both subordinate offices and Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H),

Ghaziabad, an autonomous organization under Ministry of Ayush vide gazette notification dated 06 th July, 2020.

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/  medicines,  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, thereunder and compliance to these quality standards are mandatory for the production of ASU&H drug being manufactured in India. During the last five years, 60 quality standards on raw materials (Single Drugs of  plant/animal/Mineral/  Chemical  origin)  used  in  Ayurveda  and  Unani  system  of medicine, 03 quality standards of Ayurveda, Siddha and Unani (ASU) formulations, 219 formulary specifications of ASU drugs has been published in respective pharmacopoeias and formularies.

PCIM&H also act  as  an  appellate  drug  testing  laboratory  and  receives  samples from government agencies as per the Drugs & Cosmetics Act, 1940 and rules thereunder for ascertaining their quality. Year-wise details of drug samples tested by PCIM&H are at .  Further,  year-wise  details  of  training  conducted  by  PCIM&H  to  Drug

Annexure -III Regulatory Authorities, State Drug Testing Laboratories etc. are at Annexure-III.

(b) and (c) No shortage of raw materials  has been reported to Ministry of Ayush. Further, increase  the  availability  of  medicinal  plants  raw    material,  National  Medicinal  Plants Board (NMPB) under Ministry of Ayush has implemented 'Central Sector Scheme on Conservation, Development and Sustainable Management of Medicinal Plants' throughout the country, with an outlay of Rs. 322.41 crore for a period of five years from 2021-22  to  2025-26.  For  the  current  financial  year  2023-24,  Rs.43.49  crore  has  been allocated  under  the  said  scheme.  This  Central  Sector  Scheme  is  aimed  at  providing project based support for the following activities:

1. in-situ conservation / ex-situ conservation

## 2. Information Education Communication activities like Training/ Workshops/ Seminars/ Conference etc.

3. Research and Development
4. Promotion, marketing and trade of medicinal plants produce.
5. Establishment of nurseries
6.  Forward  and  backward  linkage  in  supply  chain  of  medicinal  plants  (Integrated component)

National  Medicinal  Plants  Board  (NMPB)  supports  demand  and  supply  study from time to time and had conducted an extensive survey and compiled a book entitled 'Medicinal Plants in India: An Assessment of their Demand and Supply' during the year 2017.

The annual demand of herbs/ medicinal plants in the country was estimated about 5,12,000 Metric Tones in 2014-15. Further, as per this study, about 1178 medicinal plants species recorded in practices of trade, out of which 242 species are traded in high volume with an estimate of more than 100 MT per annum. The study was published in year 2017 is available on www.nmpb.nic.in   under title 'Medicinal Plants in India: An Assessment of  their  Demand  and  Supply,  Ved  and  Goraya  (2017)'.  Further,  as  per  the  second advance for the financial year 2023-24, (statistics division, Ministry of Agriculture and Farmers  Welfare)  an  area  of  742,000  hectare  has  been  covered  under  cultivation  of Medicinal and Aromatic Plants with Production of 645,000 MT.

Central Council for Research in Homoeopathy (CCRH) has Center of Medicinal Plants Research in Homoeopathy (CMPRH), Ooty, Tamil Nadu. This institute is engaged in cultivation, survey, collection and maintenance of germplasm of exotic and indigenous plants  used  in  homoeopathy  Center  of  Medicinal  Plant  Research  in  Homoeopathy (CMPRH) at Emerald, Nilgiris district, Tamil Nadu under Central Council for Research in Homoeopathy (CCRH) is maintaining, cultivating the germplasm of 104 plant species (92 exotic and 12 indigenous) medicinal plants used in homoeopathy.

Central Council for Research in Siddha (CCRS) through Siddha Medicinal Plants Garden, Mettur Dam cultivates medicinal plants to meet the demand for the production of

Siddha  formulations  at  Pharmacy  of  CCRS  and  also  for  supply  for  the  research  and related purpose.

(d) Ministry of Ayush has taken following steps to make regulatory system  in the Ayush sector more effective:

- (i)  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.

(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 five 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.

Detailed guidelines of AOGUSY scheme are available at https://ayush.gov.in/images/Schemes/aoushdhi.pdf .

(iii)    Pharmacovigilance  Centres  for  Ayurveda,  Siddha,  Unani  and  Homoeopathy (ASU&H) Drugs set up in different  parts  of  the  country  under  the  Central  Scheme  of Ministry of Ayush are mandated to monitor and report the misleading advertisements to the  respective  State  Regulatory  Authorities.  A  three  tier  structure  comprising  of  a National Pharmacovigilance Co-ordination Centre (NPvCC), Intermediary Pharmacovigilance Centres (IPvCs) and Peripheral Pharmacovigilance Centres (PPvCs) is  established.  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.    Objectionable  advertisements  are  being  reported to the respective State Licensing Authorities by PPvC at regular intervals. Also, as per National Commission for Indian System of Medicine Regulations, 2022 and National Commission for Homoeopathy regulations, 2022, Pharmacovigilance is a mandate component for all the  Ayush  system  of  medicine.  Also,  1500  awareness  programs  have  been  conducted with 115283 beneficiaries.

(iv) 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/ medicines, 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,  thereunder  and  compliance  to  these  quality standards are mandatory for the production of ASU&H drug being manufactured in India.

(v) The National Commission for Indian System of Medicine (NCISM) is the statutory body constituted under NCISM Act, 2020. NCISM is a regulatory body and has notified 15 regulations to regulate medical education, examination, degree recognition, institution, research,  ethics  and  registration  of  practitioners.  These  regulations  are  available  at https://ncismindia.org/under-ncism-act-2020.php.

(vi)  The  National  Commission  for  Homoeopathy  has  notified  10  regulations  and  its details are available at https://nch.org.in.

(vii)  Ministry of Ayush vide gazette notification no. G.S.R. 716 (E) dated 01.10.2021 has reduced  23  identified  compliances  related  to  Ayurveda,  Siddha  and  Unani  drugs  to reduce the compliance burden.

******

## (i) Year wise details of budget allocated to Ministry of Ayush -

| Year      | Allocation of budget (Rs. In Crore)   |
|-----------|---------------------------------------|
| 2019-20   | Rs. 1939.76                           |
| 2020-21   | Rs. 2122.08                           |
| 2021-22   | Rs. 2970.30                           |
| 2022-23   | Rs. 3050                              |
| 2023-2024 | Rs. 3647.50                           |

## (ii) Total Number of Ayush Hospitals, Beds, Dispensaries and Registered Practitioners (Doctors) the countries during the years 2018-2022 -

|   S.No. | Facility                           | 2018     | 2019     | 2020     | 2021     | 2022     |
|---------|------------------------------------|----------|----------|----------|----------|----------|
|       1 | Hospitals                          | 3,986    | 3,781    | 3,859    | 3,844    | 3,859    |
|       2 | Beds                               | 56,586   | 60,632   | 60,653   | 60,943   | 61,549   |
|       3 | Dispensaries                       | 27,199   | 29,091   | 29,951   | 36,848   | 37,385   |
|       4 | Registered Practitioners (Doctors) | 7,99,879 | 6,46,013 | 7,12,132 | 7,55,780 | 7,30,317 |

(Source: State/UT Governments and Concerned Agencies)

- (iii) Total number of Ayush manufacturing units in the country during the years 2018-2022 -

|                           | 2018   | 2019   | 2020   | 2021   | 2022   |
|---------------------------|--------|--------|--------|--------|--------|
| Ayush Manufacturing Units | 8,954  | 8,407  | 8,104  | 8,648  | 8,705  |

(Source: State/UT Governments and Concerned Agencies)

## (iv) Year-wise turnover of IMPCL during past five years -

| Year    | Turn over     |
|---------|---------------|
| 2018-19 | Rs.86.83 Cr.  |
| 2019-20 | Rs.97.04 Cr.  |
| 2020-21 | Rs.164.02 Cr. |
| 2021-22 | Rs.260.84 Cr. |
| 2022-23 | Rs.223.23 Cr. |

## Annexure-I

## Year-wise details of Ayush colleges established during last five years -

A. Year-wise details of Ayurveda, Siddha, Unani and Sow-Rigpa colleges increased in last five years are as follows-

| S.no.                    | Year                     |   Ayurveda |   Siddha |   Unani |   Sowa-Rigpa |
|--------------------------|--------------------------|------------|----------|---------|--------------|
| 1.                       | 2019-20                  |         13 |       02 |      01 |           01 |
| 2.                       | 2020-21                  |         02 |        0 |      01 |            0 |
| 3.                       | 2021-22                  |         47 |        0 |       0 |           01 |
| 4.                       | 2022-23                  |         42 |       02 |       0 |           01 |
| 5.                       | 2023-24                  |         46 |       02 |       0 |            0 |
| Total increased colleges | Total increased colleges |        150 |       06 |      02 |           03 |

- B.   Year wise details of number of Homoeopathic medical colleges established in last five with sanctioned undergraduate and postgraduate seats, is as follows -

|   Sr. No. | Years   |   Total Colleges |   New colleges permitted |   Under graduate seats |   Post graduate seats |
|-----------|---------|------------------|--------------------------|------------------------|-----------------------|
|         1 | 2019-20 |              247 |                       00 |                  18537 |                  1406 |
|         2 | 2020-21 |              247 |                       00 |                  18537 |                  1406 |
|         3 | 2021-22 |              259 |                       12 |                  19407 |                  1606 |
|         4 | 2022-23 |              270 |                       11 |                  21473 |                  1788 |
|         5 | 2023-24 |              277 |                       07 |                  21965 |                  2051 |

## A. Year-wise details of drug samples tested by PCIM&H are as follows -

|   S.no. | Year                | Homoeopathy   |   Ayurveda, Siddha and Unani (ASU) |   Total |
|---------|---------------------|---------------|------------------------------------|---------|
|       1 | 2019-20             | 599           |                                 44 |     643 |
|       2 | 2020-21             | 303           |                                 24 |     327 |
|       3 | 2021-22             | 1006          |                                 02 |    1008 |
|       4 | 2022-23             | 243           |                                 28 |     271 |
|       5 | 2023-24             | NIL           |                                 45 |      45 |
|       6 | 2024-25 (Till date) | NIL           |                                 03 |      03 |

- B. Year-wise details of training conducted by PCIM&H to Drug Regulatory Authorities, State Drug Testing Laboratories etc. are as follows -

| Year    |   No. of training program conducted |   No. of participants attended |
|---------|-------------------------------------|--------------------------------|
| 2019-20 |                                  02 |                             23 |
| 2020-21 |                                  03 |                            263 |
| 2021-22 |                                  02 |                             54 |
| 2022-23 |                                  02 |                             88 |
| 2023-24 |                                  04 |                             49 |
| 2024-25 |                                  01 |                             18 |

## Annexure-III