Lok Sabha Question No. 710 (UNSTARRED), answered on 2024-07-26
Subject: Qualitative Production and Distribution of AYUSH Medicines
Ministry: AYUSH
Asked by: Shri Balwant Baswant Wankhade, Shri Dharambir Singh, Shri Vijay Kumar Dubey, Shri Vishnu Dayal Ram, Shri P P Chaudhary, Shri Pradeep Purohit, Smt. Poonamben Hematbhai Maadam, Shri Devendra Singh Alias Bhole Singh, Shri Parshottambhai Rupala, Smt. Kamaljeet Sehrawat, Shri Mukesh Rajput, Shri Bhartruhari Mahtab, Dr. Nishikant Dubey

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 710 TO BE ANSWERED ON 26 th  JULY 2024

## 'Qualitative Production and Distribution of AYUSH Medicines'

710. Shri Balwant Baswant Wankhade:

Shri Dharambir Singh:

Shri Vijay Kumar Dubey:

Shri Vishnu Dayal Ram:

Shri P P Chaudhary:

Shri Pradeep Purohit:

Smt. Poonamben Hematbhai Maadam:

Shri Devendra Singh Alias Bhole Singh:

Shri Parshottambhai Rupala:

Smt. Kamaljeet Sehrawat:

Shri Mukesh Rajput:

Shri Bhartruhari Mahtab:

Dr. Nishikant Dubey:

Will the Minister of AYUSH be pleased to state:

- (a)  the  steps  taken  by  the  Government  for  the  qualitative  production  and  distribution  of  AYUSH medicines  and  the  steps  Government  proposes  to  take  for  widening  and  deepening  research  in AYUSH medicines;
- (b) whether Government proposes to develop AYUSH parks on the banks of Ganga river;
- (c) if so, the details thereof; and
- (d) the steps taken by the Government to popularize AYUSH medicines in India and abroad?

## ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAP RAO JADHAV)

- (a) The  steps  taken  by  the  Government  for  the  qualitative  production  and  distribution  of AYUSH medicines are as follows:
- (i) The Drugs & Cosmetics Act, 1940 and Rules made there under have exclusive regulatory provisions  for  Ayurvedic,  Siddha,  Unani,  and  Homoeopathy  drugs.  Provisions  relating  to Ayurveda,  Siddha  and  Unani  Drugs  are  contained  in  Chapter  IVA  and  Schedule-  I  of  the

Drugs and Cosmetics Act, 1940 and in Rules 151 to 169, Schedules E(I), T  & TA of the Drugs  and  Cosmetics  Rules,  1945.  Further  Second  Schedule  (4A)  of  the  Drugs  and Cosmetics Act, 1940 provides standards for Homoeopathic drugs and  Rules 2dd, 30AA, 67 (C-H),  85  (A  to  I),  106-A,  Schedule  K,  Schedule  M-I  of  the  Drugs  and  Cosmetics  Rules, 1945 pertain to Homoeopathic drugs. It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including proof of safety  &  effectiveness,  compliance  with  the  Good  Manufacturing  Practices  (GMP)  as  per Schedule T & Schedule M-I of Drugs and Cosmetics Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

(ii) Ministry of Ayush, Government of India 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  ASU&H drugs, which serve as official compendia for ascertaining the Quality Control (identity,  purity  and  strength)  of  the  ASU&H  drugs,  included  herein,  as  per  Drugs  & Cosmetics Act, 1940 and Rules 1945, thereunder and compliance to these quality standards are mandatory for the production of ASU&H  drug  being manufactured in India. Implementation  of  these  pharmacopoeial  standards  ensures  that  the  medicines  reaching  to masses conform to optimum quality standards in terms of identity, purity and strength. So far, 2259  quality  standards  on  raw  materials  (Single  Drugs  of  plant/animal/Mineral/metal/ Chemical  origin)  used  in  ASU&H  has  been  published.  PCIM&H  also  acts  as  the  Central Drugs  Laboratory  for  Indian  Medicine  and  Homoeopathy  for  the  purpose  of  testing  or analysis of ASU&H Drugs. Further, it imparts Capacity Building Trainings at regular interval for standardization/quality control/ testing or analysis of ASU&H drugs to Drug Regulatory Authorities,  State  Drug  Testing  Laboratories  (Drug  Analyst)  and  other  stakeholders  on quality control of ASU&H drugs on laboratory techniques and methods used to maintain the quality of ASU&H drugs.

(iii)  Further  Ministry  of  Ayush encourages following  certifications of AYUSH products as per details below:-

-  The  scheme  for  Certification  of  Pharmaceutical  Product  (CoPP)  as  per  World Health  Organization  (WHO)  guidelines  is  extended  to  Ayurvedic,  Siddha  and Unani (ASU) medicines. This scheme is administered by Central Drugs Standard Control Organization (CDSCO) and the certificate is granted on the basis of joint

inspection of the applicant manufacturing unit by the representatives of CDSCO, Ministry of Ayush and the concerned State Licensing Authority.

-  Quality  Certifications  Scheme  implemented  by  the  Quality  Council  of  India (QCI) for grant of AYUSH mark to Ayurvedic, Siddha and Unani products on the basis  of  third-party  evaluation  of  quality  in  accordance  with  the  status  of compliance to international standards.

(iv)  Ministry  of  Ayush  implementing  Central  Sector  Scheme  of  AYURSWASTHYA Yojana  since  FY  2021-22.  Under  the  AYUSH  and  Public  Health  Component  of AYURSWASTHYA Yojana, there is provision of distribution of AYUSH medicines and organize free medical camps in such localities like  rural, tribal population and slums in cities etc.

The steps Government proposes to take for widening and deepening research in AYUSH medicines are as follows:

(i)  Government  of  India  has  established  Central  Council  for  Research  in  Ayurvedic Sciences, Central Council for Research in Unani Medicine, Central Council for Research in  Homoeopathy,  Central  Council  for  Research  in  Siddha  and  Central  Council  for Research in Yoga & Naturopathy under the Ministry of Ayush as apex organizations for undertaking,  coordinating,  formulating,  developing  and  promoting  research  in  Ayush system on scientific lines. Core Research activities comprise of Medicinal Plant Research (Medico-Ethno  Botanical  Survey,  Pharmacognosy  and  in-vitro-propagation  technique), Drug Standardization, Pharmacological Research, Clinical Research, Literary Research & Documentation  and  Tribal  Health  Care  Research  Programme.  Research  activities  are carried  out  through  its  peripheral  Institutes/Units  located  across  the  country  and  also  in collaboration with various Universities, Hospitals and Institutes.

(ii)  Further,  the  Ministry  of  Ayush  is  running/implementing  the  Central  Sector  Scheme namely AYURGYAN Scheme from FY 2021-22.The Scheme has 03 components viz. (i) Capacity Building & Continuing Medical Education (CME) in AYUSH (ii) Research & Innovation in AYUSH from the FY 2021-22 and iii) Ayurveda Biology Integrated Health Research is also added under the scheme from this FY 2023-24. Under the Research & Innovation  in  AYUSH  and  Ayurveda  Biology  Integrated  Health  Research  component, financial assistance is provided to the Organizations/Institutions for research studies, for promotion of research in AYUSH system.

(b) and (c ) No sir.

(d)  The  steps  taken  by  the  Government  to  popularize  AYUSH  medicines  in  India  and abroad are as follows:

- (i) The Ministry of Ayush, Government of India has developed a Central Sector Scheme for Promotion  of  International  Co-operation  in  AYUSH  (IC  Scheme)  with  the  mandate  to promote  and  strengthen  awareness  and  interest  about  AYUSH  Systems  of  Medicine  at international  level;  to  facilitate  International  promotion,  development  and  recognition  of AYUSH system of medicine; to foster interaction of stakeholders and market development of AYUSH at international level; to give boost to AYUSH products/ services / education/ research/  training  globally;  to  promote  academics  and  research  through  establishment  of AYUSH Academic  Chairs  in  foreign  countries;  setting  up  of  AYUSH  Information  Cell abroad to disseminate authentic information about Ayush system in the foreign communities etc.
- (ii) Under the AYUSH Fellowship program of the IC scheme, 104 scholarships are offered every year to the eligible foreign nationals from 102 countries for pursuing AYUSH courses in  premier  Institutes  in  India.    Ministry  of  Ayush  has  signed  24  Country  to  Country Memorandum  of  Understanding (MoUs)  for cooperation in the field of traditional medicines; 50 MoUs with international institutes for undertaking Collaborative Research / Academic collaboration and 15 MoUs with international institutes for setting up of Ayush Academic Chairs in foreign nations. Under these MoUs, various activities for promotion of Ayurveda education, research, products & services.

(iii)  Various  multilateral  forums  like  G  20,  Bay  of  Bengal  Initiative  for  Multi-Sectoral Technical  and  Economic  Cooperation  (BIMSTEC),  BRICS  (Brazil,  Russia,  India,  China, and South Africa), IBSA (India, Brazil, South Africa), Shanghai Cooperation Organization (SCO) etc. are being effectively utilized to  get  global  recognition  to  Ayurveda  and  other AYUSH systems.

(iv)  The  Ministry  implements  the  Central  Sector  Scheme  for  Promotion  of  Information Education  and  Communication  (IEC)  in  Ayush  to  create  awareness  regarding  Ayush System  of  Medicine.  This  aims  to  reach  out  to  all  sections  of  the  population  across  the country. This scheme provides assistance for organizing National/State Arogya Fairs, Yoga

Fests/Utsavs, Ayurveda Parvs, etc. The Ministry also undertakes Multi-Media, Print Media Campaigns for creating awareness about the Ayush System.

(v) Central Council for Research in Ayurvedic Sciences (CCRAS), through its Information Education  and  Communication  (IEC)  Activities,  has  been  engaged  in  popularizing  the Ayurveda system among the masses through electronic and print media for common people in English, Hindi, and regional languages, which are widely distributed through National/State  level  Arogya  melas,  Health  camps,  exhibitions,  expos,  various  activities related to Azadi ka Amrit Mahotsav 2.0 (AKAM 2.0), International year of millets etc. and also  through  CCRAS  outreach  programs  viz.  Schedule  Caste  Sub  Plan  (SCSP)  Research Program,  Tribal  Health  Care  Research  Program  (THCRP),  etc.,  in  different  states  of  the country through its robust 30 peripheral institutes. Further, IEC materials are also put on the Council's  website  for  wider  publicity.The  Council  has  launched  three  electronic  journals named Journal of Drug Research in Ayurvedic Sciences (JDRAS), Journal of Research in Ayurvedic Sciences (JRAS), and (JIMH) Journal Of Indian Medical Heritage and put them in the public domain free of cost to enable dissemination of the outcomes of research among the public. So far, the Council has published about 400 books, monographs, and  technical  reports,  and  they  are  being  sold  or  distributed  to  disseminate  research outcomes and merits of Ayurveda at large.

(vi)  The  Council  has  also  developed  four  digital  platforms,  viz.  AYUSH  Manuscripts Advanced  Repository  (AMAR),  Showcase  of  Ayurvedic  Historical  Imprints  (SAHI),  EMedical Heritage Accession (E-Medha), Research Management  Information System (RMIS)  and  maintains  a  website  entitled  Ayush  Research  Portal  in  which  all  published research  information  related  to  all  Ayush  systems  is  uploaded  systematically  for  wider utility  and  visibility  of  research.  The  Council  website  is  also  generally  embodied  with information  on  Ayurveda  and  hyperlinked  with  other  important  websites  that  provide information for wider utility.

(vii) Central Council for Research in Homoeopathy (CCRH) under Ministry of Ayush has been participating in the imitational Seminars/ Conferences all over the world delegates and as  Resource  Persons  for  paper  presentations  at  International  Platforms.  CCRH  has  also signed  Memoranda  of  Understanding  (MoU)  with  foreign  universities  for  undertaking collaborative  research.  National  Institute  of  Homoeopathy  (NIH)  participates  in  Arogya Mela,  Gangasagar  Mela,  School  Health  Check-ups,  etc.  to  make  aware  the  public  of  the Homoeopathic system of medicine.

(viii)  The  Central  Council  for  Research  in  Unani  Medicine  (CCRUM)  has  taken  various initiatives for popularizing Unani system of Medicine in the country by different methods e.g. providing treatment through General OPD, RCH OPD, Geriatric OPD, NCD Clinic etc. conducted by 19 Clinical Institutes / Units of the Council. The Council is also popularizing Unani system of medicine through Arogyas, Health Melas, Health Camps, and Exhibitions etc.  Besides  the  school  health  programme  and  clinical  mobile  research  programme, SCSP/TSP mobile health program is being carried out by the Council for the promotion of Unani  Medicine.  Under  this  programme,  villages  having  SC/ST  population  have  been selected  to  create  awareness  for  preventive  aspects  of  different  diseases  and  to  provide treatment to the patients through different centres of the Council. The CCRUM has entered into following agreements with certain countries for Research and Development of Unani Medicine.

-  Establishment  of  Unani  Chair  at  University  of  Western  Cape,  Cape  Town,  South Africa.
-  MoU with Hamdard University, Bangladesh for establishment of Unani Chair
-  MoU with Tajikistan for Research and Development of Unani Medicine
-  MoM with Iran

(ix) National Institute of Siddha (NIS) has been taking various steps for promoting Siddha System of medicine across the country by participating in Arogya fair etc., This Institute has created awareness about Siddha System of medicine to the people outside Tamil Nadu. The Institute also conducts many programmes like Siddha Day celebration, CMEs, Workshops, Seminars, and Conferences to create more awareness about Siddha System of medicine.

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