Lok Sabha Question No. 130 (UNSTARRED), answered on 2019-06-21
Subject: Scientific Testing of Traditional Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Pushpendra Singh Chandel

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

LOK  SABHA UNSTARRED  QUESTION NO . 130 TO BE ANSWERED ON 21 ST JUNE, 2019

## SCIENTIFIC TE STING OF TRADITIONAL MEDICINES

## 130. SHRI KUNWAR PUSHPENDRA SINGH CHANDEL:

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

- (a)  whether the  Government  is  contemplating/has  contemplated  any  policy  for  the  scienti testing  of  traditional  medicines  and  build  a  system  for  the  monitoring  of  the  qual effectiveness of the traditional medicines, if so, the details thereof;
- (b)  whether the  Government  has  given  sanction  to  conduct  these  tests  on  humans,  if  so, details thereof; and
- (c)  the  details  of  measures  taken  by  the  Government  to  encourage  the  export  of  tradi medicines?

## ANSW ER

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

(a) & (b):     Standards of traditional medicines of Ayurveda, Siddha and Unani (ASU) sy are  developed  on  the  basis of  scientific  parameters,  which  are  prescribed  in  the  respecti pharmacopoeias.    The  Pharmacopoeia  Commission  of  Indian  Medicine  &  Homoeopathy  and Pharmacopoeia  Committees  are  engaged  with  scientific  institutions  to  develop  the  stand which are mandat ory for the manufacturers of  ASU medicines in accordance with the provisio of  Drugs & Cosmetics Act, 1940 and Rules there under.  Accordingly, the extant Rule 158 - B of the Drugs & Cosmetics Rules, 1945 prescribes the regulatory requirement of proof of safety and effectiveness, inter alia based on pilot studies, for licensed manufacturing of various of  Ayurvedic,  Siddha  and  Unani  medicines.  Enforcement  of  these  provisions  is  under purview  of  the  Licensing  Authorities/Drug  Controllers  appoi nted  by  the  State  Governments. Ministry of AYUSH has published 'Good Clinical Practice Guidelines for conduct of clinical trials  in  Ayurveda,  Siddha  and  Unani  Medicine.  These  guidelines  are  for  voluntary  use encompass the design, conduct, termination, audit, analysis, reporting and documentation of the systematic  studies  involving  human  subjects  for  determining  the  safety  and  efficac Ayurvedic, Siddha and Unani (ASU) medicines and to ensure that the studies are scientif and ethically sound and the clinical properties  of the ASU medicines  under investigation a properly documented. Research Councils under Ministry of AYUSH and the Indian Council fo

Medical  Research  (ICMR)  are  promoting  and  carrying  out  research  in  the  area  of  tradit medicines through intramural and extramural research activities.

( c): Measures adopted for encouraging the export of Ayurvedic, Siddha and Unani medicine are as under: -

- i) Provision of issuing Free Sale Certificate for the export - orient d ASU medicines is made in the Drugs & Cosmetics Rules, 1945.
2. ii) Labelling provisions under Drugs & Cosmetics Rules, 1945 are exempted for ASU medicines exported to other countries.
3. iii) System of quality certification under WHO - GMP  Guidelines  is  in  place  under  the administrati ve purview of Drugs Controller General for facilitating international t of ASU medicines.
4. iv) Quality Council of India has implemented a scheme of certification to grant AYUS Standard and AYUSH Premium marks of quality to ASU medicinal products.
- v) Good Clinical Practice (GCP) Guidelines published for conduct of clinical tria ASU medicines.
6. vi) Registration of clinical trials of ASU drugs has been included in the Clinical Registry  of  India  (CTRI)  maintained  by  Indian  Council  for  Medical  Research (ICMR).
7. vii) Morbidity  codes  and  standardized  terminology  of  Ayurvedic,  Siddha  and  Unani systems  have  been  developed  on  the  lines  of  WHO  International  Classification Diseases (ICD).
8. viii) Standardization and Research & Development (R&D)  of  ASU medicines is being promoted by and large done on the basis of integrated protocols and methodolog involving globally acceptable scientific parameters.
9. ix) Financial  support  has  been  made  available  to  the  manufacturers/entrepreneurs preparation of product dossiers and registration of ASU medicines in foreign markets and for participation in international trade fairs, exhibitions and business meet
- x) Ministry of AYUSH has established AYUSH Information Cells in Indian Missions and  entered  into  MoUs  with    foreign  coun tries  for    promoting  international cooperation in the area of traditional medicine, mutual recognition pharmacopoeias, establishment of Ayush Chairs and for collaborative activities.
11. xi) Pharmaceutical  Export  Promotion  Council - Pharmexcil    covers  export  m atters  of ASU products.