Lok Sabha Question No. 2064 (UNSTARRED), answered on 2017-12-29
Subject: Efficacy of AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: SHRIKANT EKNATH SHINDE, VINAYAK BHAURAO RAUT, Shrirang Appa Barne, KUNWAR PUSHPENDRA SINGH CHANDEL, ANANDRAO  ADSUL, DHARMENDRA YADAV, PRITAM GOPINATH MUNDE

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

LOK  SABHA UNSTARRED  QUESTION NO. 2064 TO BE ANSWERED ON 29 TH DECEMBER, 2017

## EFFICACY OF AYUSH ME DICINES

## 2064. DR. SHRIKANT EKNATH SHINDE:

SHRI VINAYAK BHAURAO RAUT:

SHRI SHRIRANG APPA BARNE:

SHRI KUNWAR PUSHPENDRA SINGH CHANDEL:

SHRI ANANDRAO ADSUL:

SHRI DHARMENDRA YADAV:

DR. PRITAM GOPINATH MUNDE:

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

- (a) whether in a bid to lend authenticity to traditional medicines, the Government has clinical  testing  of  various  ayurvedic and  homoeopathic  medicines  on  patients  suffering  from different tropical diseases and if so, the details thereof;
- (b) whether these trials are conducted with the approval of the patients;
- (c) if so, the details thereof and if not, the reasons therefor ;
- (d) whether his Ministry has also formed a Central Council for Research in Ayurvedic Sci and if so, the details and functioning thereof; and
- (e)  whether  the  Government  has  made  any  efforts  to  monitor  quality  and  efficacy  of medicines  sold  i n  the  market  and  boost  infrastructure  for  manufacturing  of  ayurvedic  a homoeopathic  medicines  to  promote  such  drugs  internationally  and  if  so,  the  details  t along with the other steps taken by the Government to promote the AYUSH treatments in country?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (SHRI SHRIPAD YESSO NAIK)

- (a) to (c):  Central Research Councils of Ayurveda and Homoeopathy under the Ministry of AYUSH have  taken  up  scientific  studies  to  evaluate  and  validate  various  Ayurvedic  and  Homo medicines for the treatment of tropical diseases including Malaria, Filariasis, Dengue, and Japanese encep halitis. Clinical studies on these medicines are conducted with prior i

consent of the patients in writing and complying to the standard ethical guidelines and G Practices (d): Yes, the Central Council for Research in Ayurvedic Scie nces has been established by the Government as an apex autonomous organization to undertake, coordinate, formulate, devel promote research activities in Ayurveda on scientific lines.  The Research Council has 30 institutions  spread  across the  country  and  also  collaborates  with  different  universities,  s institutions  and  hospitals.  Core  scientific  activities  of  the  Council  include  Drug  St Research,  Pharmacological  Research,  Clinical  Research,  Literary  Research  &  Document ation, Medicinal  Plant  Research  including  Medico - Ethn - Botanical  Survey  and  Public  health  oriented research interventions.

(e): Government has made exclusive regulatory provisions under Drugs & Cosmetics Act, 1 and Rules thereunder for the manufact uring,  sale and quality control  of Ayurvedic an Homoeopathic  medicines.  Pharmacopoeia  Commission  of  Indian  Medicine  &  Homoeopathy  and respective  Pharmacopoeia  Committees  have  been  set  up  to  develop  quality  standards  of medicines and publish them in the Ayurvedic and Homoeopathic Pharmacopoeia.  It is mandatory for  the  drug  manufacturers  to  take  license  for  manufacturing  of  Ayurvedic  and  Homoeo medicines  by  fulfilling  the  requirement  of  proof  of  safety  &  effectiveness  and  comply standar ds  given  in  the  pharmacopoeia  and  Good  Manufacturing  Practices  (GMP)  prescribed Drugs & Cosmetics Rules, 1945. Licensing Authorities or Drug Controllers appointed by th Governments are responsible to enforce the legal provisions for manufacturing and quality control of Ayurvedic and Homoeopathic medicines. GMP certification of the manufacturing units is ess required for grant or renewal of license.  Drug testing facilities are provided throug laboratories,  27  State  Laboratorie s,  55  approved  or  licensed  laboratories  and  various  NABL -accredited  laboratories.  For  facilitating  export  of  AYUSH  products  to  the  internatio Central  Drug  Standards  Control  Organization  (CDSCO)  and  Quality  Council  of  India  ( respectively admi nister certification schemes based on WHO Guidelines and International Stan Other  steps  taken  by  the  Government  to  promote  AYUSH  include  implementation  of  Natio AYUSH Mission to expand & strengthen health services, teaching institutions, drugs qu ality control and cultivation & sustainable development of medicinal plants and extension of support number of Central Sector Schemes for the benefit of related stakeholders.

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