Lok Sabha Question No. 6544 (UNSTARRED), answered on 2018-04-06
Subject: Testing of Traditional Drugs
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: RAJEEV SHANKARRAO SATAV, HEENA VIJAYKUMAR GAVIT, SUPRIYA SADANAND SULE, JAYAKUMAR JAYAVARDHAN, P.R. SUNDARAM, VIJAYSINH MOHITE PATIL

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

LOK  SABHA UNSTARRED  QUESTION NO. 6544 TO BE ANSWERED ON 6 TH APRIL, 2018

## TESTING OF TRADITION AL DRUGS

6544. SHRI SATAV RAJEEV:

DR. HEENA VIJAYKUMAR GAVIT:

SHRIMATI SUPRIYA SULE:

DR. J. JAYAVARDHAN:

SHRI P.R. SUNDARAM:

SHRI MOHITE PATIL VIJAYSINH SHANKARRAO:

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

- (a)whether the Government is concerned about the traditional drug manufacturers indulgin unethical  business  practices  mainly  due  to  the absence  of  a  formal  protocol  on  testing  of traditional  drugs  for  their  safety  and  if  so,  the  details  thereof  and  the  ac tion  taken  by  the Government 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  hosp itals  in  the  country  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 the co untry 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): The traditional drugs of Ayurveda, Siddha and Unani (ASU) systems are regula the country in accordance with the provisions of Drugs & Cosmetics Act, 1940 and thereunder. Manufacturing of such drugs needs grant of license from the concern e Licensing Authority on compliance to the Good Manufacturing Practices (GMP), qualit

Contd………

standards  prescribed  in  the  pharmacopoeias  including  permissible  limits  of  heavy aflatoxins,  pesticide  residue  and  microbial  load  and  evidence  of safety  and  effectiveness. Testing parameters and protocols for the quality analysis of these drugs are presc respective  pharmacopoeias.    Misbranded,  Adulterated,  Spurious  and  Substandard drugs, which may not be safe for human use, are defin ed in the Drugs & Cosmetics Act, 1940 along with the penal provisions for the defaulters.

(b)&  c) : The  extant  Rule  158 - B  of  the  Drugs  &  Cosmetics  Rules,  1945  prescribes  th regulatory requirement of submission of proof of safety and effectiveness inter a lia based on pilot  studies  for  obtaining  manufacturing  license  of  various  categories  of  AS Ministry  of  AYUSH  has  published  'Good  Clinical  Practice  Guidelines  for  conduct  of clinical  trials  in  ASU  medicine.  However,  the  term  'clinical  trial'  is  not provided  in  the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder pertainin manufacturing for sale of ASU drugs under license. There is no legal provision for or notifying any specific clinics or hospitals for conducting clinical trials for traditional drugs including Ayurvedic, Siddha, Unani and Homoeopathic drugs.

(d):    As of now there is no proposal to establish Homoeopathy medicines manufacturing u central Government in the Ministry of AYUSH.  However, through Cent rally Sponsored Scheme of National  AYUSH  Mission  (NAM),  the  grant -in - aid  is  provided    for  the  establishment  and strengthening of State AYUSH manufacturing units including Homeopathy medicine manufacturing units.

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