Lok Sabha Question No. 83 (STARRED), answered on 2022-07-22
Subject: Patents for Ayurvedic Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Prataprao Govindrao  Patil Chikhalikar

## GOVERNMENT OF INDIA MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH)

## LOK SABHA STARRED QUESTION NO. 83 TO BE ANSWERED ON 22 ND  JULY, 2022

## PATENTS FOR AYURVEDIC MEDICINES

## †*83. SHRI PRATAPRAO PATIL CHIKHLIKAR:

Will the Minister of AYUSH be pleased to state:

- (a) whether the Government is aware that the Department of Ayush is not giving any importance to the patent of Ayurvedic medicines;
- (b) if so, whether there are any valid reasons for the same;
- (c)  the  number  of  medicines  which  have  been  approved  after  getting  the  patent during the  last  three  years  and  the  number  of  medicines  that  are  yet  to  obtain  a patent;
- (d) the number of such proposals received during the last three years in respect of which  patents  have  been  obtained  but  approval  are  still  pending  with  the Department along with the main reasons for such pendency;
- (e) the details and steps taken by the Government to avoid such pendency; and
- (f)  the  details  of  major  features  and  steps  taken  by  the  Government  to  promote Ayurveda at the global level?

THE MINISTER OF AYURVEDA, YOGA & NATUROPATHY, UNANI,

## ANSWER SIDDHA AND HOMOEOPATHY(AYUSH)

(SHRI SARBANANDA SONOWAL)

- (a) to (  f) A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 83* FOR 22 ND  JULY, 2022

(a)  to  (f)  Sir,  Office  of  Controller  General  of  Patents,  Designs  and  Trade  Marks (O/o CGPDTM) exclusively deals with processing and grant of patents in different fields of various technological aspects Ayurvedic medicine. The patent applications  filed  before  the  office  of  CGPDTM  having  Ayurvedic  background must ascertain whether the claimed invention is novel, inventive and industrially applicable  and  should  not  fall  under  the  known  prior  domain  knowledge  of Ayurveda.  It  is  to  be  noted  that  prior  existing  knowledge  on  Ayurveda  is  not  a patentable subject matter as per section 3 of the Patents Act, 1970 (as amended). As  per  the  information  received  from  Office  of  Controller  General  of  Patents, Designs and Trade Marks, the number of patent applications filed and number of granted  patent  having  Ayurveda  related  proprietary  knowledge  during  the  year 2019 to 2022 is as follows:

|   Year |   No. of patent applications applied having Ayurveda related proprietary knowledge |   No. of patent applications granted having Ayurveda related proprietary knowledge |
|--------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
|   2019 |                                                                                178 |                                                                                 36 |
|   2020 |                                                                                256 |                                                                                 48 |
|   2021 |                                                                                242 |                                                                                 01 |
|   2022 |                                                                                185 |                                                                                 01 |

Government is committed to promote and provide the access of Ayurveda medicine  and  encourage  the  innovation  on  the medicinal  plants  known  in Ayurveda literature. Ministry of Ayush is giving due importance to the patent of Ayurvedic medicines. National Institutes and Research Councils under the Ministry of Ayush are actively involved in patenting the research outcomes.

1. Central  Council  for  Research  in  Ayurvedic  Sciences  (CCRAS)  under Ministry  of  Ayush  has  signed  a  Memorandum  of  Understanding  (MoU)  with National Research Development Corporation (NRDC), Department of Scientific & Industrial Research (DSIR), and Ministry of Science &Technology for expediting and  finalization  of  patenting  process.  CCRAS  is  applying  for  patents  to  Indian Patent  Office,  through  NRDC  as  per  the  provisions  of  Indian  Patent  Act.  In  the past three years, one patent viz. System for providing restorative/relaxation bathing (Collaborative Patent Filed in India with IIT, Delhi) with patent no. 330609 dated 29.01.2020 has been granted to CCRAS. Following two patents applications filed by CCRAS for technologies/ processes -

|   S. No. | Name of the patent                                                   | Application Filed no.                           |
|----------|----------------------------------------------------------------------|-------------------------------------------------|
|        1 | A comprehensive tool for therapeutic induction of Enema              | Ref. no. 202111041967(TEMP/E- 1/47165/2021-DEL) |
|        2 | Systems and Methods For Automated Manufacturing of Medicated Threads | Ref. no. 1536IN102                              |

Total 18 patents has been granted to Central Council for Research in Ayurvedic Sciences (CCRAS) which are as follows-

|   S. No. | Name of the patent                                                                                                                                                        | Patent Granted No./Date   |
|----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
|        1 | A process for the production of a Lactonic glycoside from Nerium indicum Mill. (syn. N. odorum Sol.)                                                                      | 138350/ Dt. 26.09.73      |
|        2 | A process for the production of an Extract useful in the treatment of Bronchial asthma from Mesua ferrea Linn. Seeds                                                      | 139868/ Dt.04.04.74       |
|        3 | A process for the production of a Sodium Salt of a natural 2-methyl chromone isolated from the pods of Cassia siamea                                                      | 140032/ Dt. 04.04.74      |
|        4 | A process for the isolation of a Pongaflavone from Pongamia pinnata (L.) Pierre (syn. P.glabra)                                                                           | 140321/ Dt. 04.04.74      |
|        5 | A process for the production of a Benzofuran derivative from kojic acid and catechol                                                                                      | 139869/ Dt. 04.04.74      |
|        6 | AYUSH-56 - Process for preparation of therapeutically active anti-epileptic preparation                                                                                   | 141170/ Dt. 28.07.1976    |
|        7 | A process for the preparation of 9,13-Epoxy-6 β- hydroxy-8α- Labdone-16,15, 19,20-diolactone 2 known as Nepetaefolinol from the whole plant of Leonotis nepetaefolia Linn | 147936/ Dt. 14.08.78      |
|        8 | A process for the isolation of Vincristine from Vinca rosea                                                                                                               | 150019 /Dt. 12.06.79      |
|        9 | A process for the preparation of vinblastine from Vinca rosea                                                                                                             | 150024/Dt. 12.06.79       |

|   10. | AYUSH-64 - A process for the preparation of a therapeutically active anti-malarial preparation.                                                                                            | 152863/ Dt.28.07.1980           |
|-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
|    11 | A process for preparation of an Ayurvedic formulation for the treatment of Leukemia                                                                                                        | 191708/ Dt. 23.8.1999           |
|    12 | Ksharsutra - A medicated thread for Ano- Rectal diseases                                                                                                                                   | 186243/ Dt.15.02.2002           |
|    13 | A Process for the Preparation of Novel Composition from Swertia chirata Buch. Ham. (Gentianaceae) having Anti-carcinogenic (cancer Preventive) and anti- Tumor (Cancer Therapeutic) Action | 191128/ Dt. 26.3.2002           |
|    14 | A Process for the Isolation of Amarogentin, Novel Seco-Iridoid Glycoside Possessing Anti- carcinogenic (Cancer Preventive) and Anti- Tumor (Cancer Therapeutic) Action                     | 191129/ Dt. 26.3.2002           |
|    15 | AYUSH Ghutti -'A herbo-mineral formulation' for cough and cold                                                                                                                             | 193336/ Dt. 8.11.2004           |
|    16 | Pharmaceutical ayurvedic preparation                                                                                                                                                       | US 6,939,567B1/ Dt. 06. 09.2005 |
|    17 | BAL RASAYAN - A process for the preparation of a herbo- mineral preparation for general immunity and strengthening of children                                                             | 196916/ Dt.07.07.2006           |
|    18 | Collaborative Patent Filed in India with IIT, Delhi System for providing restorative/relaxation bathing                                                                                    | 1703/DEL/2008 Dt. 29.01.2020    |

CCRAS  is  encouraging  Scientists  to  file  patents  of  new  innovations  and technologies and to expedite this, CCRAS has constituted Translational Research, Intellectual Property Rights & Business Development Cell (TRIPR&BD). Further, CCRAS  is  collaborating with National Research Development Corporation (NRDC) for facilitating the patent filing, patent processing etc. with Indian Patent Office by engaging Patent Attorneys. Total 20 Technology transferred to industry by CCRAS.

2. All  India  Institute  of  Ayurveda  (AIIA),  New  Delhi      has  established  a dedicated  cell  for  formulating  Intellectual  Property  Rights  (IPR)  policy  for  the institute. AIIA has filed an application for granting Patent by Government of India entitled  'Evaluating  efficacy  of  H-4  compound  aerosol  nebulization  in  sputum positive tuberculosis subjects'. Faculty member of All India Institute of Ayurveda, New Delhi has also obtained following patents:

- i. Patent over nootropic effects of combination of all four Medhya Herb from South  African  Patent  authority  on  dated  30.03.2022  entitled  'Clinical Competence  of Medhya  Rasayana combination in mild to moderate Intelligent Quaficient deficit Children'
- ii. Patent entitled 'A hydroalcoholic composition of Swarna Prashan formulation  for  pediatric  age  group'  granted  by  official  patent  agency  of Federal of republic of Germany.

3.  The  Ministry  has  developed  a  Central  Sector  Scheme  for  Promotion  of International Co-operation in AYUSH (IC Scheme) under which the Ministry of Ayush provides support to Indian Ayush Manufacturers/ Ayush Service providers to  give  boost  to  the  export  of  AYUSH  products  &  services;  facilitates  the International  promotion,  development  and  recognition  of  AYUSH  system  of medicine; foster interaction of stakeholders and market development of AYUSH at international level; promote academics and research through the establishment of AYUSH Academic Chairs in foreign countries and holding training workshop/symposiums  for  promoting  and  strengthening  awareness  and  interest about AYUSH Systems of Medicine at international level.

Ministry  of  Ayush  has  taken  the  following  steps  towards  the  promotion international collaborations and investments towards the promotion of Ayurveda at the global level:

-  Ministry has signed 25 Country to Country MoUs for Cooperation in field of Traditional Medicine and Homoeopathy with foreign nations.
-  37  MoUs  have  been  signed  with  international  institutes  for  undertaking Collaborative Research / Academic collaboration.
-  15  MoUs  have  been  signed  with  international  institutes  for  setting  up  of AYUSH Academic Chairs in foreign nations.
-  Ministry  of  Ayush  has  provided  support  for  establishment  of  38  Ayush Information Cells in 34 foreign nations.
-  Ministry of Ayush under its International Fellowship/Scholarship Programme offers  scholarships  to  foreign  nationals  for  undertaking  AYUSH  courses  in recognized AYUSH institutions in India.
-  MoUs have been signed with London School of Hygiene & Tropical Medicine (LSH&TM), UK and  Frankfurter  InnovationszentrumBiotechnologie  GmbH (FIZ), Frankfurt Germany for clinical research studies on mitigation of Covid19 through Ayurveda.
-  Ministry of Ayush issued advisories to improve general immunity of people & to protect them from COVID and stay healthy. The advisories were issued in 08 foreign languages in addition to English.
-  Ministry  of  Ayush  provides  Training  to  regulators  of  foreign  nations  to generate awareness about the AYUSH systems.
-  Ministry  of  Ayush  in  cooperation  with  QCI  has  got  developed  Quality Certification  programmeviz.Ayush  mark  and  Premium  mark  to  increase reliability of standards of ASU&H Products.
-  WHO-GMP (COPP) has been given to 31 Ayurvedic Drug manufacturers to facilitate the export of Ayurveda, Siddha, and Unani & Homoeopathy Drugs.
-  Ministry of Ayush and WHO have signed an agreement to establish WHOGCTM in Jamnagar, Gujarat, the ground-breaking  Ceremony  of  which  was attended by the Hon'ble Prime Minister of India, Director General of WHO and  other  esteemed  dignitaries  on  19.04.2022  in  Jamnagar,  Gujarat.  This Centre  aims  to  provide  support  to  implement  WHO's  traditional  medicine strategy  (2014-23)  and  to  support  nations  in  developing  policies  &  action plans to strengthen the role of traditional medicine as part of their journey to universal health coverage.
-  A  Memorandum  of  Understanding  (MoU)  has  been  signed  between  the Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), Ministry of Ayush and American Herbal Pharmacopoeia, USA on  13 th September,  2021  for  strengthening,  promotion,  and  development  of standards  in  the  field  of  Ayurveda  and  other  Indian  Traditional  systems  of medicine  between  the  two  countries  on  the  basis  of  equality  and  mutual benefit.
-  An  India-EU  Technical  Working  Group  (TWG)  on  Ayurveda  has  been established. The Technical Working Group has the representation of technical experts  from  the  Ministry  of  Ayush,  Government  of  India,  the  European Commission, the European Medicines Agency (EMA) and its Committee on Herbal Medicinal Products (HMPC).
-  Ministry of Ayush has organized a three day Global Ayush Investment and Innovation  Summit  (GAIIS) from  20  -22  April,  2022  at  Mahatma  Mandir, Gandhinagar, Gujrat. The Global Ayush investment and Innovation Summit, 2022 was a distinctive effort by the Government of India to attract the world's attention to India's ancient wisdom and traditional knowledge, and capitalize on it to pave the way for a sustainable future. The Summit was organized in line  with  Sustainable  Development  Goal  Number  3  of  promoting  'Good Health and Well-being.' A total of five plenary sessions, eight roundtables, six workshops, and two symposiums were organized and 90 eminent speakers and 100 exhibitors participated during GAIIS.

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