Lok Sabha Question No. 114 (STARRED), answered on 2024-02-09
Subject: Integration of Traditional Medicines in National Health System
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Ranjeetsingh Naik Nimbalkar, Saikia Dilip

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA STARRED QUESTION No.114 ANSWERED ON 9 TH  FEBURARY, 2024

## Integration of Traditional Medicines in National Health System

## *114   SHRI RANJEETSINGH NAIK NIMBALKAR: SHRI DILIP SAIKIA:

Will the Minister of AYUSH be pleased to state:

(a) whether the Government proposes to formulate any plan to integrate aspects like standardization,  quality  and  safety  of  traditional  and  complementary  medical  system  into  the National Health System and also to disseminate those at the international level;

(b) if so, the details thereof and if not, the reasons therefor; and

(c) the details of fresh steps taken/proposed to be taken by the Government for preserving the rich heritage of traditional and complementary medicines as well as making it modern, authentic and globally acceptable?

## ANSWER

## THE MINISTER OF AYUSH (SHRI SARBANANDA SONOWAL)

(a) to (c) A Statement is laid on the Table of the House.

## The Statement referred to in reply to Lok Sabha Starred Question No. 114 for 9 th February, 2024

(a) & (b)   National Health Policy- 2017 inter-alia recognizes the need to standardize and validate Ayurvedic  medicines  and  establish  a  robust  and  effective  quality  control  mechanism  for  Ayush drugs.

Ministry  of  Ayush  has  established  Pharmacopoeia  Commission  for  Indian  Medicine  & Homoeopathy (PCIM&H), as its subordinate office. PCIM&H on behalf of Ministry of Ayush lays down  the  Formulary  specifications  and  Pharmacopoeial  Standards  for  Ayurveda,  Siddha,  Unani and Homoeopathy (ASU&H) drugs, which serve as official compendia for ascertaining the Quality Control (identity, purity and strength) of the ASU&H drugs, as per Drugs & Cosmetics Act, 1940 and Rules 1945, framed thereunder. The compliance to these quality standards are mandatory for the production of ASU&H drugs being manufactured in India. The quality parameters included in the  Pharmacopoeias  and  Formularies  of  Ayurveda,  Siddha,  Unani  &  Homoeopathic  (ASU&H) drugs  prescribing  mandatory  regulatory  standards  have  been  identified  to  align  the  parameters prescribed  by  WHO/other  major  pharmacopoeias  prevalent  worldwide.  Implementation  of  these pharmacopoeial  standards  ensures  that  the  medicines  reaching  to  masses  conform  to  optimum quality standards in terms of identity, purity and strength.

The  Drugs  &  Cosmetics  Act,  1940  and  Drugs  &  Cosmetics  Rules,  1945  have  exclusive regulatory provisions for Ayurvedic, Siddha and Unani (ASU) medicines. Section 3(a), 3(h)(i) of the Act exclusively pertain to ASU medicines and similarly regulatory provisions for Ayurvedic, Siddha and Unani drugs are prescribed in Rules 151 to 170 of Drugs & Cosmetics Rules, 1945. As prescribed in Drugs and Cosmetics Act 1940 and Rules 1945 made thereunder, enforcement of the  legal  provisions  pertaining  to  Quality  Control  and  issuance  of  drug  license  of  Ayurveda, Siddha, Unani and Homoeopathy drugs, is vested with the State Drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government.

Ministry  of  Ayush  has  implemented  a  Central  Sector  Scheme  Ayush  Oushadhi  Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) on 16.03.2021 with total allocation of Rs. 122.00 crores for five years. The components of scheme are as under:

- A. Strengthening  and  up-gradation  of  Ayush  Pharmacies  and  Drug  Testing  Laboratories  to achieve higher standards.
- B. Pharmacovigilance of ASU &H drugs including surveillance of misleading advertisements.
- C. Strengthening  of  Central  and  State  regulatory  frameworks  including  Technical  Human Resource & Capacity Building programs for Ayush drugs.
- D. Support for development of standards and accreditation/certification of Ayush products & materials in collaboration with Bureau of Indian Standards (BIS), Quality Control of India (QCI) and other relevant scientific institutions and industrial Research & Development Centres.

Central  Council  for  Research  in  Ayurvedic  Sciences  (CCRAS),  Central  Council  for Research in Unani Medicine (CCRUM), Central Council for Research in Homoeopathy (CCRH), Central  Council  for  Research  in  Siddha  (CCRS)  and  Central  Council  for  Research  in  Yoga  & Naturopathy  (CCRYN)  are  autonomous  organizations  under  Ministry  of  Ayush  for  research  in Ayurveda, Unani, Homoeopathy, Siddha and Yoga & Naturopathy respectively and these councils are conducting different research activities through their peripheral institutes available in different parts  of  the  country.  CCRAS,  CCRUM,  CCRH,  CCRS  and  CCRYN  are  working  towards  the

scientific validation in the concerned system of medicines through clinical research, drug research, medicinal plants research, fundamental research, literary research and documentation.

In addition, Memorandum of Understanding is signed between the Ministry of Ayush and the Quality Council of India (QCI), through its Board, National Accreditation Board for Hospitals & Healthcare Providers (NABH), for NABH AYUSH entry level certification (AELC) of Ayush Health  &  Wellness  Centers  (AHWCs)  which  has  been  established  by  upgrading  existing  Ayush dispensaries  and  integrated  Ayush  hospitals  supported  under  the  NAM  scheme.  Accordingly,  at present,  390  AHWCs  have  been  approved  for  certification  as  per  the  decision  of  Certification Committee.

Ministry of Ayush also developed a Central Sector Scheme for Promotion of International Co-operation  in  Ayush  under  which  various  activities/initiatives  has  been  undertaken  or  being undertaken for the promotion, propagation & to disseminate Ayush system of medicine globally i.e. offering  Ayush  scholarships  to  foreign  nationals  for  undertaking  Ayush  courses  in  recognized Ayush institutions in India; collaboration with Foreign Countries by signing of country level MoU for undertaking Ayush related activities on mutual interest; signing of MoUs with foreign institute for research/academic collaboration; establishment of Ayush Chairs in Foreign Universities/Institutes; deputation of Ayush expert (short term/long term); collaboration with WHO or UN agencies for cooperation in the field of Ayush, support or organizing international training; conference, seminar, expo etc. in India or abroad for promoting and strengthening awareness and interest  about  Ayush  Systems  of  Medicine  at  international  level;  establishment  of  Ayush  cell (center)  in  foreign  countries  to  provide  authentic  information  about  Ayush  system;  representing Ayush in various multilateral forums like- Brazil, Russia, India, China and South Africa (BRICS), Shanghai Cooperation  Organisation (SCO), G20,  IBSA,  Association  of  Southeast  Asian  Nations (ASEAN),  Bay  of  Bengal  Initiative  for  Multi-Sectoral  Technical  and  Economic  Cooperation (BIMSTEC) etc., support for undertaking clinical research in Ayush at international level etc.

(c) The  Traditional  Knowledge  Digital  Library  (TKDL)  was  conceptualised  and  initiated  in 2001 as a collaborative effort between the Council of Scientific and Industrial Research (CSIR) and the  Department  of  Indian  Systems  of  Medicine  &  Homeopathy  (now  Ministry  of  Ayush).  The TKDL database currently contains Indian traditional medicine knowledge from classical/ traditional books available  in  public  domain  related  to  Ayurveda,  Unani,  Siddha  &  Sowa  Rigpa  as  well  as Yoga  practices  in  a  digitized  format  and  is  available  in  five  international  languages  (English, French, German, Spanish and Japanese). The value-added content of over 4.6 lakh formulations in TKDL provides  contemporary,  equivalent  terminologies  relating  to  ingredients,  metrics,  disease conditions, etc. Thus, the TKDL not only protects the traditional knowledge related to medicinal systems, but also preserves the knowledge in a format and language understandable and accessible to patent examiners, researchers and practitioners.

Ministry  of  Ayush  signed  a  Donor  Agreement  with  World  Health  Organization  (WHO) towards  the  implementation  of  developing  a  Second  Module  in  the  Traditional  Medicine  (TM) Chapter of the International Classification of Diseases -11 Revision (ICD-11). The document has been launched in January 2024.

*****