Lok Sabha Question No. 3882 (UNSTARRED), answered on 2022-03-25
Subject: Scientific validation and documentation of AYUSH Drugs
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Sanjay(Kaka) Ramchandra Patil

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 3882 TO BE ANSWERED ON 25 th  March, 2022

## SCIENTIFIC VALIDATION AND DOCUMENTATION OF AYUSH DRUGS

## 3882. SHRI SANJAY KAKA PATIL:

Will the Minister of AYUSH be pleased to state:

(a) whether the Government has undertaken steps to initiate more clinical trials to fill up the gap due to lack of evidence based medicines;

- (b) if so, the details thereof;
- (c)  whether  the  Government  has  undertaken  steps  towards  scientific  validation  and  strong documentation of AYUSH drugs; and
- (d) if so, the details thereof?

(a) Yes, Sir.

(b)  Government  has  set  up  separate  Central  Research  Councils  for  promoting  scientific validation  of  Ayurvedic,  Unani,  Siddha  and  Homoeopathic  medicines.  Further,  Ministry  of Ayush  has  taken  steps  to  facilitate  clinical  trials  in  Ayush,  like  publication  of  Good  Clinical Practice  in  Ayurveda,  Siddha and  Unani  Medicine (GCP-ASU)  and Good Clinical Practice  in Homoeopathy  with  the  objective  that  the  studies  are  ethical  and  scientific  so  that  clinical properties  of  the  ASU&H  medicines  under  investigation  are  properly  documented,  issuing directive for registration of AYUSH clinical trials in Clinical Trials Registry of India. Also, Rule 158-B of the Drugs Rules, 1945 specifies for providing the proof of effectiveness and safety of certain  categories  of  Ayurvedic,  Siddha  and  Unani  medicines  as  a  pre-requisite  for  obtaining license.

## ANSWER THE MINISTER OF AYUSH (SHRI SARBANANDA SONOWAL)

(c) Yes, Sir. (d)  For  Standardization  of  Indian  medicines  in  the  country,  the  Government  has  established Pharmacopoeia  Commission  for  Indian  Medicine  and  Homoeopathy  (PCIM&H)  under  the Ministry of Ayush. The prime mandate of the Commission is to publish and revise Ayurvedic Pharmacopoeia of India (API), Siddha Pharmacopoeia of India (SPI), Unani Pharmacopoeia of India (UPI) and Homoeopathic Pharmacopoeia of India (HPI). The Pharmacopoeial standards are basic need to ensure quality, safety and efficacy of Ayurvedic, Siddha, Unani and Homoeopathic medicines. The Pharmacopoeia Commission is also responsible to publish and revise Ayurvedic, Siddha and Unani official formularies and regulatory compendiums. These published standards become part  of  Drugs  and  Cosmetics  Act,  1940  and  Rules,  1945  for  ascertaining  the  quality standards of Raw materials and finished drugs and are implemented uniformly across India. Further, the separate Central Research Councils working under the aegis of Ministry of Ayush are working towards the scientific validation of the Ayush systems of medicine through clinical research,  pre-clinical  research,  drug  research,  medicinal  plant  research,  fundamental  research, literary research and documentation. Data of 34333 such research articles published on Ayush systems are available at 'ayushportal.nic.in'.

Also,  Ministry  is  implementing  Central  Sector  Scheme  namely,  'Ayurgyan  Scheme  Yojana' (erstwhile Extra Mural Research Scheme). Research & Innovation in AYUSH is a component of this scheme and funds are provided to institutions to support and encourage research activities in all streams of AYUSH  their scientific validation and documentation. Further, under 'Ayurswastha  Yojana' (Central  Sector  Scheme),  financial  assistance  is  provided  to  Individual Organizations/Institutes through its Centre of Excellence component for Research and Development  activities  in  AYUSH  Medicines/Fundamentals/therapeutics  etc.  and  through  its Public Health component for documentation of the efficacy of AYUSH interventions in various public health issues which can be taken up in larger scale for implementation in national health programme.

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