Lok Sabha Question No. 1522 (UNSTARRED), answered on 2016-03-04
Subject: Clinical Trial of Traditional Drugs
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: K. C. VENUGOPAL

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

(AYUSH)

LOK  SABHA UNSTARRED QUESTION NO. 1522 TO BE ANSWERED ON 4 TH MARCH, 2016

## CLINICAL TRIAL OF TR ADITIONAL DRUGS

## 1522. SHRI K.C. VENUGOPAL:

## Will the Minister of AYURVEDA,YOGA AND NATUROPATHY, UNANI, S1DDHA AND HOMOEOPATHY(AYUSH) be pleased to state:

- (a) whether the Government is concerned about the traditional drug manufacturers indulgi unethical  business  practices  mainly  due  to  the  absence  of  a  formal  protocol  on  test traditional drugs for their safety and if so, the actions taken by the G overnment in this regard;
- (b) whether there is any mechanism to do clinical trials for traditional drugs before the hit the market and if so, the details thereof;
- (c)  whether  the  Government  has  approved  any  clinics  or  hospitals  in  the  countr y  to  conduct clinical trials for traditional drugs including Ayurveda, Unani, Siddha and Homoeopathy so, the details thereof; and
- (d) whether the Government proposes to establish Homoeopathy medicine manufacturing unit Alappuzha, 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): Quality  standards  &  testing  protocols  and  Good  Manufacturing  Practices  of  Ayurv Siddha and Unani (ASU) drugs are prescribed in the pharmacopoeias and Drugs & Cosmetics R 1940 respectively, which are mandatory for the manufacturers to follow. Regulatory provi licensing  and  quality  control  of  ASU  drugs    are  made  and  amende d  in  consultation  with  the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board, which is a statutory body set the Government under the provisions of Drugs & Cosmetics Act, 1940 to advise the Centr State Governments in technical matters o f d ugs. 41 laboratories in private sector are approved the  provisions  of  Drugs  &  Cosmetics  Rules,  1945  and  one  Central  Laboratory  and  27 Laboratories  are  in  place  to  carry  out  testing  of  ASU  drugs.  Central  Research  Coun undertake safe ty & efficacy studies of classical ASU formulations and support is provided Extramural Research Scheme to such projects.  Since the enforcement of Drugs & Cosmetic and Rules thereunder for ASU drugs is vested with the State Governments, compla ints and matters concerning safety aspects of these drugs are taken up with the respective states from time

( b) &( c) : As per the regulatory provisions prescribed in the Drugs & Cosmetics Rules, 1945, the proof of safety and effectiveness is required for the purpose of licensing of various Ayurvedic,  Siddha  and  Unani  drugs.  ASU  drugs  not  having  textual  rationale  or  evidence scientific literature need to under go safety and efficacy evaluation studies for consideration of of manufacturing license.    The Government has published Good Clinical Practice guidel conduct of clinical trials for Ayurvedic, Siddha and Unani drugs and a directive issued t have th se clinical trials registered with the Clinical Trials Registry, India (CTRI). experts is also in place in the Ministry of AYUSH to examine the proposals of clinical tr permission of the Government.  As such t here is no provision to approve clinics or hospitals clinical  trials.  The  pre - requisites  for  conduct  of  clinical  trials  are  detailed  in  the  Good Practice guidelines.

( d): The  State  Government  of  Kerala  has  established  'the  Kerala  State Homoeopathic  Co operative  Pharmacy  Limited  (HOMCO)'  since  1978,  which  was  supported  under  the  Centrally Sponsored  Scheme  of  Drugs  Quality  Control  during  the  10 th Plan.  There  is  no  proposal  under consideration of Central Government to set up any Homoeopa thy medicines manufacturing unit in Alappuzha.