Lok Sabha Question No. 1088 (UNSTARRED), answered on 2023-12-08
Subject: Productivity of Ayurveda Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Vijay Kumar Dubey

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 1088 TO BE ANSWERED ON 08.12.2023

## 'Productivity of Ayurveda Medicines'

## 1088.  SHRI VIJAY KUMAR DUBEY:

Will the Minister of Ayush be pleased to state:

(a)  the  roadmap  prepared/proposed  to  be  prepared  by  the  Government  to  increase  the productivity  of  Ayurveda  and  other  Indian  medicine  products/herbs  across  the  country, State/UT-wise;

(b) the details of the productivity of such AYUSH medicines during the last three years and the current year in the country, State/UT-wise including Uttar Pradesh;

(c) whether any Central Scheme implemented by the Government has strengthened the safety and vigilance/monitoring mechanism for ensuring the quality of AYUSH medicines/drugs;

(d)  if  so,  the  details  thereof  along  with  the  process  of  assessing/evaluating  the  quality  and identification of adverse effects of such medicines/ drugs; and

(e) the steps taken/proposed to be taken by the Government for qualitative production/distribution of AYUSH medicines along with widening and deepening the scope of their research?

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

(a)  and  (b)  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. Rule 158-B in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Ayurvedic, Siddha, Unani 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 of Drugs and Cosmetics Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

Details of the Ayurvedic medicines Turnover of IMPCL for last three years including U.P is as under:

| Year    | Value         |
|---------|---------------|
| 2022-23 | Rs. 174.53 Cr |
| 2021-22 | Rs. 230.15 Cr |
| 2020-21 | Rs. 139.65 Cr |

As  per  the  information  received  from  various  State/  UTs,  the  details  of  productivity  of Ayush  medicines  and  the  steps  taken  to  increase  the  productivity  of  Ayurveda  and  other Indian medicine products/herbs are at Annexure-I.

- (c)  and  (d)  Yes  Sir.    In  the  year  2021,  Ministry  of  Ayush  has  implemented  Central  Sector Scheme AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY). 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 are available at https://ayush.gov.in/images/Schemes/aoushdhi.pdf.

Pharmacovigilance Program for Ayurveda, Siddha, Unani, and Homoeopathy (ASU & H) Drugs  has  been  established  under  the  Central  Sector  Scheme  of  Ministry  of  Ayush (AOGUSY Scheme).  The  program  is  working  through  a  three-tier  network  of  a  National Pharmacovigilance Centre (NPvCC), Five Intermediary Pharmacovigilance Centres (IPvCs)

and 99 Peripheral Pharmacovigilance Centres (PPvCs) established across the country. Under the Pharmacovigilance Program for ASU & H Drugs major objectives are to keep vigilance over Ayush drugs and to report misleading advertisements. Through three tiers network of Pharmacovigilance  (NPvC,  IPvC,  PPvC)  regular  reporting  of  suspected  adverse  drug reactions is being done. Since 2018 to till date, 1637 such individual case safety reports have been reported in a specified format for reporting such adverse reactions.

Also,  there  is  regular  reporting  of  objectionable  advertisements  appearing  in  print  and electronic media. Since 2018 to till date, 32,527 such misleading advertisements have been reported. All misleading advertisements are being reported to the respective State Licensing Authorities  by  peripheral  centers  at  regular  intervals  for  the  possibility  of  initiating  action against the defaulters.

As on date, 35 Drug Testing Laboratories have been established under state governments and  Union  Territories.    Further,  102  laboratories  are  approved  or  licensed  under  the provisions of Rule 160 A to J of the Drugs and Cosmetics Rules, 1945 for, quality testing of Ayurvedic, Siddha and Unani drugs and raw materials.

(e) The steps taken by the Ministry of Ayush for qualitative production/distribution of Ayush medicines along with widening and deepening the scope of their research are as follows (i)  05 Research Councils under Ministry of Ayush are engaged in activities like Medicinal Plant Research (Medico-Ethno Botanical Survey, Pharmacognosy and Tissue Culture), Drug & Documentation and Tribal Health Care Research Programme.  Further, 12 National Institutes

Standardization, Pharmacological Research, Clinical Research, Literary Research under Ministry of Ayush are also conducting various research studies on Ayush drugs.

Ministry of Ayush has also implemented AYURGYAN Scheme for promoting education and research in the field of Ayush and to support Research & Innovation in Ayush by extra mural research and education in Ayush by providing academic activities, training, Capacity Building  etc.  Further,  under  the  Centre  of  Excellence  component  of  AYURSWASTHYA Yojana,  financial  assistance  is  provided  to  eligible  individual  organizations/institutes  for establishing  and  upgrading  their  functions  &  facilities  and/or  for  research  &  development activities in Ayush.

(ii)  Rule  160  A  to  J  of  the  Drugs  and  Cosmetics  Rules,  1945  provides  the  regulatory guidelines  for  approval  of  Drug  Testing  Laboratory  for  carrying  out  such  tests  of  identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani  drugs.  As  on  date,  35  State  Drug  Testing  Laboratories  have  been  supported  for strengthening  their  infrastructural  and  functional  capacity.    Further,  102  laboratories  are approved or licensed under the provisions of Drugs and Cosmetics Rules, 1945 for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials.

(iii)  For  facilitating  exports  of  Ayush  products,  Ministry  of  Ayush  encourages  following certifications of Ayush products as per details below:-

-  Certification of Pharmaceutical Products (CoPP) as per WHO Guidelines for herbal products.
-  Quality Certifications Scheme implemented by the Quality Council of India (QCI) for grant of Ayush Premium mark to Ayurvedic, Siddha and Unani products on the basis of  third  party  evaluation  of  quality  in  accordance  with  the  status  of  compliance  to international standards.

(iv) As per the information received from States/UTs -

-  State/UT has also constituted technical expert committee regarding approval of patent & proprietary  Ayush drugs  after  verifying  the  submission  of  documents  relating  to safety study, evidence of effectiveness and stability studies as per Rule 158B, Rule 161B and Rule 169 of Drugs & Cosmetics Rules, 1945.
-  State Government of Odisha has made provisions for funds towards manufacture of Ayurvedic  medicines  in  the  Government  pharmacies  of  the  State  at  Bolangir, Bhubaneswar  and  Puri.  The  State  Drugs  Testing  and  Research  Laboratory  (ISM), Bhubaneswar  is  functioning  as  in-house  laboratory  of  these  pharmacies  for  quality testing of the drugs.
-  State of Kerala has appointed a committee to study the standardization of Ayurveda drugs in the state, as per order number G.O.(P) 291/2023/AYUSH dated 01/08/2023. Research and development facilities need to be established in the state, and currently, no  government  agencies  are  engaged  in  the  research  and  development  of  Ayush drugs/products.

*******

## Annexure-I

Details  of  steps  taken  to  increase  the  productivity  of  Ayurveda  and  other  Indian  medicine products/herbs -

|   S.No. | Name of the State/UT   | Information received from State/ UT government                                                                                                                                                                                                                                 |
|---------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Haryana                | The ASU Drug Manufacturing License is being issued to increased ASU Drug manufacturers under the provisions of Drug and Cosmetic Act, 1940 and Rules made thereunder. There are 994 ASU drug manufacturing units in the Haryana State.                                         |
|       2 | Himachal Pradesh       | The provisions of Drugs & Cosmetic Act/Rules made thereunder & instruction/guidelines issued by the Ministry of Ayush, Govt. of India are being followed.                                                                                                                      |
|       3 | Kerala                 | Kollam District Oushadha Nirmana Co-operative Society Limited has received an amount of Rs. 64.29 Lakh under AOGUSY scheme.                                                                                                                                                    |
|       4 | Assam                  | Nil                                                                                                                                                                                                                                                                            |
|       5 | Maharashtra            | Nil                                                                                                                                                                                                                                                                            |
|       6 | Puducherry             | Nil                                                                                                                                                                                                                                                                            |
|       7 | Gujarat                | Nil                                                                                                                                                                                                                                                                            |
|       8 | Madhya Pradesh         | Nil                                                                                                                                                                                                                                                                            |
|       9 | Goa                    | Nil                                                                                                                                                                                                                                                                            |
|      10 | Odisha                 | At present 03 nos. of Government Ayurvedic Drug manufacturing units are functioning in the State at Bolangir, Bhubaneswar and Puri to increase the productivity of Ayurveda and other Indian medicine products. The details of the productivity of such Ayush medicines during |

unit

|     |           | the last three years and the current year for Odisha is as under   | the last three years and the current year for Odisha is as under   | the last three years and the current year for Odisha is as under               | the last three years and the current year for Odisha is as under               | the last three years and the current year for Odisha is as under   | the last three years and the current year for Odisha is as under   |
|-----|-----------|--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|
|     |           |                                                                    | Financial Year                                                     | Financial Year                                                                 | Allotment in the Medicine                                                      | Allotment in the Medicine                                          | Allotment in the Medicine                                          |
|     |           |                                                                    | 2020-21                                                            | 2020-21                                                                        | Rs. 2,72,60,000/-                                                              | Rs. 2,72,60,000/-                                                  | Rs. 2,72,60,000/-                                                  |
|     |           |                                                                    | 2021-22                                                            | 2021-22                                                                        | Rs. 2,72,60,000/-                                                              | Rs. 2,72,60,000/-                                                  | Rs. 2,72,60,000/-                                                  |
|     |           |                                                                    | 2022-23                                                            | 2022-23                                                                        | Rs. 2,72,60,000/-                                                              | Rs. 2,72,60,000/-                                                  | Rs. 2,72,60,000/-                                                  |
|     |           |                                                                    | 2023-24                                                            | 2023-24                                                                        | Rs. 7,67,60,000/-                                                              | Rs. 7,67,60,000/-                                                  | Rs. 7,67,60,000/-                                                  |
| 11. | Karnataka | Details of productivity of Ayurvedic medicines are as follows -    | Details of productivity of Ayurvedic medicines are as follows -    | Details of productivity of Ayurvedic medicines are as follows -                | Details of productivity of Ayurvedic medicines are as follows -                | Details of productivity of Ayurvedic medicines are as follows -    | Details of productivity of Ayurvedic medicines are as follows -    |
|     |           |                                                                    | S.no .                                                             | Category of medicine                                                           | Category of medicine                                                           | Quantity production metric system)                                 | of (in                                                             |
|     |           |                                                                    | 1.                                                                 | Anjana/Pisti                                                                   | Anjana/Pisti                                                                   | 0                                                                  | 0                                                                  |
|     |           |                                                                    | 2.                                                                 | Churna/ Nasya Manjan/ Lepa/ Kwath Churn                                        | Churna/ Nasya Manjan/ Lepa/ Kwath Churn                                        | 18883.06 tons                                                      | 18883.06 tons                                                      |
|     |           |                                                                    | 3.                                                                 | Pills/ Vatti/ Gutika/ Matirai and                                              | Pills/ Vatti/ Gutika/ Matirai and                                              | 2374.89 tons                                                       | 2374.89 tons                                                       |
|     |           |                                                                    | 4.                                                                 | Kupi pakva/ Ksara/Parpati/ Lavana/ Bhasma/ Satva/ Sindhura/ Karpu/ Uppu/ Param | Kupi pakva/ Ksara/Parpati/ Lavana/ Bhasma/ Satva/ Sindhura/ Karpu/ Uppu/ Param | 274.17 tons                                                        | 274.17 tons                                                        |
|     |           |                                                                    | 5.                                                                 | Kajal                                                                          | Kajal                                                                          | 1520000.00 tons                                                    | 1520000.00 tons                                                    |
|     |           |                                                                    | 6.                                                                 | Capsules                                                                       | Capsules                                                                       | 3575.00 tons                                                       | 3575.00 tons                                                       |
|     |           |                                                                    | 7.                                                                 | Ointment/ Marham/ Pasai                                                        | Ointment/ Marham/ Pasai                                                        | 8814.95 tons                                                       | 8814.95 tons                                                       |
|     |           |                                                                    | 8.                                                                 | Pak/ Avleh/ Khand/ Modak/ Lakayam                                              | Pak/ Avleh/ Khand/ Modak/ Lakayam                                              | 10867.86 tons                                                      | 10867.86 tons                                                      |

of

|     |                | 9. Panak, Syrup/ Pravahi Kwath manapaku 1612978.79 10. Asava/ Aristha 3695962.5 11. Sura 17079.78 gallon 12. Ark/ Tinir 18646.58 gallon 13. Tail/ Ghrit/ Ney 1684979.96 14. Ashcyton/ Netra Malham panir/ 261303.54                                                                                          |                                                                                                                                                                                                                                                                                                              | gallon                                                                                                                                                                                                                                                                                                       |
|-----|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|     |                |                                                                                                                                                                                                                                                                                                              |                                                                                                                                                                                                                                                                                                              | gallon                                                                                                                                                                                                                                                                                                       |
|     |                |                                                                                                                                                                                                                                                                                                              |                                                                                                                                                                                                                                                                                                              | gallon                                                                                                                                                                                                                                                                                                       |
|     |                |                                                                                                                                                                                                                                                                                                              | Karn Bindu/ Nasabindu                                                                                                                                                                                                                                                                                        | gallon                                                                                                                                                                                                                                                                                                       |
| 12. | Andhra Pradesh | Proposal are prepared by the Andhra Pradesh Medicinal and Aromatic Plants Board production of quality planting material (QPM) through 15 small nurseries are started for increasing the productivity of raw material good agriculture practices (GAP) will be imparted to the formers to various Information | Proposal are prepared by the Andhra Pradesh Medicinal and Aromatic Plants Board production of quality planting material (QPM) through 15 small nurseries are started for increasing the productivity of raw material good agriculture practices (GAP) will be imparted to the formers to various Information | Proposal are prepared by the Andhra Pradesh Medicinal and Aromatic Plants Board production of quality planting material (QPM) through 15 small nurseries are started for increasing the productivity of raw material good agriculture practices (GAP) will be imparted to the formers to various Information |