Lok Sabha Question No. 1047 (UNSTARRED), answered on 2020-09-18
Subject: Traditional System of Medicine
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Ravindra Kushawaha

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

## LOK SABHA UNSTARRED QUESTION NO. 1047 TO BE ANSWERED ON 18 th SEPTEMBER, 2020

## TRADITIONAL SYSTEM O F MEDICINE

## 1047. SHRI RAVINDRA KUSHWAHA:

Will  the  Minister  of AYURVEDA,  YOGA  AND NATUROPATHY,  UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:

- (a)  the  action  plan  formulated  by  the  Government  to bring  the  knowledge  of  traditional medicines into mainstream by including them in modern he alth care;
- (b) whether the Government has developed any strategy for ensuring State of the art safety protocols and effective standards of traditional system of medicine, if so, the details thereof;
- (c)  whether  the  Government  is  aware  of  the  dangers emerging  to  bio - diversity  due  to excessive cutting of medicinal plants or due to increasing use of body parts of endangered animals in traditional medicines; if so, the details thereof; and
- (d) the remedial measures being taken by the Government in this r egard?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (DR. HARSH VARDHAN)

(a) & (b): A  new  category  of  drugs  called  'Phytopharmaceutical drugs'  made  from purified and standardized fraction with minimum four bio - active r phytochemical compounds  of  medicinal  plants  used  in  traditional  medicine  or  ethnomedicine  has  b included under the provisions of Drugs & Cosmetics Rules, 1945 since Nov ember, 2015 and these drugs are under the regulatory control of Central Drug Standards Control Organiz Provisions for proof of safety and effectiveness and quality standards for manufactu Ayurveda, Siddha and Unani medicines are prescribed und er Rules 158 - B  and  168  of  the Drugs  &    Cosmetics  Rules,  1945  and  respective  pharmacopoeias.  These  provisions  ar framed  by  the  Central  Government  and  enforced  by  the  State  Governments  through  th Licensing Authorities/Drug Controllers. Central Government h as established Pharmacopoeia Commission  of  Indian  Medicine  &  Homoeopathy  to  develop,  revise  and  lay  down  the standards of Ayurvedic, Siddha, Unani and Homoeopathy drugs and formulations and publis respective  Pharmacopoeias  and  Formularies.  New  indications ,  new  dosage  forms  and  new formulations of traditional medicine need to follow the procedure of quality assessme safety & effectiveness evaluation in accordance with the provisions of Drugs & Cosme Rules, 1945. Ministry of AYUSH has published Goo d Clinical Practices (GCP) guidelines based on scientific parameters for conduct of clinical trials in Ayurvedic, Siddha an medicine.

(c) & (d): Yes, Government is aware of the dangers related to biodiversity protection use of threatened speci es of animals. Accordingly, in order to conserve biological resour including  medicinal  plants,  the  National  Biodiversity  Authority  and  the  State  Biodi Boards  are  facilitating  and  regulating  the  use  of  biological  resources  and  ass knowledge for  research  and  commercial  use  in  accordance  with  the  provisions  of  t Biological Diversity Act, 2002. The Biological Diversity Act, 2002 has provisions to impose penalties for violations involving accessing of biological resources including medicina lants for commercial purpose without obtaining approval from the National Biodiversity Autho or  the  State  Biodiversity  Boards.  Biodiversity  registers  maintained  by  the  Biodi Management  Committees  record  the  details  of  available  natural  resources and  traditional knowledge including traditional medicines.

Government  has  established  National  Medicinal  Plants  Board  under  the  aegis Ministry  of  AYUSH  to  support,  undertake  and  promote  cultivation,  conservation  a sustainable development of medici nal plants and augment the supply of bio - resources  and various  raw  materials  for  the  Ayush  drugs  industry  from  cultivated  sources. Ministry  of Finance  has  recently  announced  on  15.5.2020  a  special  package  of  Rs.  4000  crore National Medicinal Plants Boa rd under Atmanirbhar Bharat Campaign to augment cultivation and development of medicinal plants over 10 lakh hectares of land. Ministry of Environ Forest  and  Climate  Change  set  up  a  Working  Group  on  19.8.2020  to  look  for  requir amendment in the Biol ogical Diversity Act, 2002, Rules - 2004  and  Access Benefit Sharing (ABS) Regulations