Lok Sabha Question No. 14 (STARRED), answered on 2018-02-02
Subject: Testing of AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: KIRIT PREMJIBHAI SOLANKI

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

## LOK SABHA STARRED QUESTION NO. 14 TO BE ANSWERED ON 2 ND FEBRUARY , 2018 TESTING OF AYUSH MED ICINES

## *14. DR. KIRIT P. SO LANKI:

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

- (a)  whether  any  guidelines  have  been  issued  by  the  Indian  Council  of  M Research regarding the adherence of standards in testing of AYUSH medicines so,the details thereof;
- (b) whether the Government has taken steps to bring research on ayurvedic dr formulations closer to international standards and if so, the details thereof
- (c) whether the Government has established ethical principles under which drug trials are  conducted  for  research  on  traditional  medicines  and  proprietary  var traditional medicines involving human participation;
- (d) if so, the details thereof and if not, the reasons therefor; and
- (e)  whether the  Government  has  adopted  any  measures  to  monitor  the  testing ayurvedic and other traditional medicines and if so, the details thereof?

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

- (a)to ( e):  A statement is laid on the Table of the House

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 14* FOR 2 ND FEBRUARY , 201 8

a) Yes,  the  'National  Ethical  Guidelines  for  Biomedical  and  Health  Research Involving Human Participants' have been issued by the Indian Council of Medical Research in the year 2017 for  observing ethical standards for human res the country. A dedica ted section - 7.13 on 'Clinical trials on Traditional Systems of Medicine' is  included in these guidelines.

b) 'Good Clinical Practice Guidelines for Clinical Trials in Ayurveda, Siddha and Unani Medicine (GCP ASU)' have been published by the Government to address the issue of protection of human rights as a subject in clinical trials assurance  of  the  safety  and  efficacy  of  the  ASU  formulations.  These  gu include standards of ho w clinical trials should be conducted; and define the and  responsibilities  of  clinical  trial  sponsors,  clinical  research monitors  etc.  The  objective  is  to  inculcate  the  culture  of  conducting Siddha  and  Unani  (ASU)  interventi on- based  clinical  studies  in  the  country accordance with requisite scientific standards and appropriately methodologies  to  bring  research  on  Ayurvedic,  Siddha  and  Unani  drugs formulations closer to international standards. The Central Counc il for Research in Ayurvedic Sciences set up by the Government is following such standard pr and guidelines for research on Ayurvedic drugs and formulations Pharmacopoeia Commission of Indian Medicine & Homoeopathy has internation collaboratio n  with  US  Pharmacopoeia  Commission  to  develop  the  standard  o Ayurvedic  drugs.  Ministry  of  AYUSH  has  also  implemented  a n Extramural Research Scheme to support scientific projects for development of Ayurved other  traditional  medicines.  International  c ollaboration  with  the  institutions Germany,  Hungary,  Argentina,  USA  etc  has  also  been  undertaken/explored scientific studies of AYUSH drugs .

c) & d) Yes, the ethical principles for conduct of research on Ayurvedic and  Unani  medicines/traditi onal  medicines  including  proprietary  varieties traditional  medicines  involving  human  participation  are  laid  down  in publications, namely the 'Good Clinical Practice Guidelines for Clinical Trials in Ayurveda,  Siddha  and  Unani  Medicine  (GCP - ASU) '  published  by  Ministry  of AYUSH  (erstwhile  Department  of  AYUSH)  in  2013  and  the  'National  Ethical Guidelines  for  Biomedical  and  Health  Research  Involving  Human  Participants' published  by  ICMR  in  2017.    The  ICMR's  Ethical  Guidelines - 2017  state  that 'Resea rch  on  AYUSH  and  ASU  interventions  of  Traditional  Medicine  (TM) including  external  medicines/therapeutic  procedures,  folk  medicines,  an and  proprietary  medicines  of  TM  involving  human  participants  shoul conducted in accordance with all the ethi cal principles described in these guideli including Serious and Adverse Event reporting and compensation, AYUSH GC guidelines, as well as other applicable regulations of the country'.

e)   GCP guidelines for clinical trials on ASU medicines contain th e provisions for the  sponsors  of  clinical  trials  to  ensure  the  studies  are  adequately The Government has also inserted Rule 158 - B in the Drugs & Cosmetics Rules, 1945 w.e.f. 10 th August, 2010 prescribing the requirement of proof of safety and effectiveness based on pilot studies for certain categories of ASU medicin purpose of licensing of such medicines. T he Government has repeatedly advised the  stakeholders  to  get  the  clinical  trials  of ayurvedic  and  other  tr aditional medicinesapproved by the Ethics Committee and have them registered with the Clinical  Trials  Registry  of  India  (CTRI)  aimed  at  safeguarding  the  in clinical trial participants and recording & dissemination of clinical tria re spectively.

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