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“If you think of standardization as the best that you know today,
but which is to be improved tomorrow; you get somewhere.”
Globalization is not only something that will concern & threaten us
in the future, but something that is taking place in the present & we
need to be aware of it now.
Globalization
Standardization: physician, medicine ,nursing, patient
Education: graduation, post graduation, research……
Drug standardization ,cultivation-manufacturing…
Evidence based management protocols, research….
Government policies -regulations
Ayurveda: Indian system of medicine ;more than 5000 years old
,holistic, personalized, traditional, time tested since centuries
Yoga –Astanga – yama-niyama-Asana-pranayama-pratyahara-
dhyana-dharana –samadhi .Not a cult or physical practice.
Unani – has own principles, very similar to Ayurveda,UNAN
Siddha –specialized Ayurveda medicine, more Rasaoushadhi
Homeopathy –simili simlipus curantum –Dr.Hanneman
Traditional –folklore –bone setters, midwives, snake poison-….
Medical pluralism is accepted in India
Physician
Medicaments
Care giver / nurse
Patient response/obedience
Standardization of Ayurvedic Education
3 National institutes, universities
Gujarat, Banaras, Jaipur, New Delh
Many colleges imparting AYUSH
courses.
Fix standards - education, syllabi & course
curricula, requirements of hospitals, faculties,
equipment, clinical exposure, examination pattern;
 to ensure adherence to laid down standards above
 to maintain a Central Register of practitioners;
Recommend to Central Government for recognition
/ withdrawal of medical qualifications awarded by
Universities;
 to lay down code of conduct, ethics and etiquette o
practitioners.
Herb cultivation -seed to sapling, land to lab –quality control
Good manufacturing practices & Good lab practices
National Medicinal plant board –central ,regional,
Drugs & cosmetics act
Ayurveda –siddha –Unani (ASU) Drug technical advisory
board & consultative committee )
Pharmacopoeial Laboratory for Indian Medicine (PLIM
WHO ,FAO (food & agricultural organisation) rules.
Finished products specification ,(FPS), MHRA, USFDA
Color, appearance, odor, taste, hardness, clarity……
Limit tests, extractive values, chemical assays …..
Viable content, total mold count, total bacterial count….
Chromatographic & spectroscopic evaluation -LC,HPTCL,
HPLC methods, TLC fingerprint evaluation herbals (FEH
Determination of heavy metals
Pesticide residue ,radio active contamination….
Herbal cultivation
Procurement, preservation, packaging raw material.
Good manufacturing practices of herbal-herbo mineral
formulations.
Intensive quality control protocols at all levels of
manufacturing
AYUSH parks, clusters created
New Delhi
A y u r v e d a S i d d h a
C e n t r a l R e s e a r c h i n s t i t u t e
A y u r v e d a S i d d h a
R e g i o n a l R e s e a r c h i n s t i t u t e
A y u r v e d a S i d d h a
R e s e a r c h U n i t s / C e n t r e s
C C R A S
Patiala
Cheruthuruthy
Junagarh
Jaipur
Kolkata
Mumbai
Gwalior
Lucknow
Bhubneshwar
Patna
Chennai
Trivandrum
ALRCA
Pune
Tarikhet
Hyderabad
Gangtok
Guwahati
Itanagar
Bangalore
Jammu
Mandi
Vijayawada
Nagpur
Jhansi
Hastinapur
Jamnagar[DSRP]
Kottakal
Pondicherry
Car-Nicobar[THCRP]
Leh
Chennai
Varanasi[DSRP]
Jamnagar[MCRU]
Palayamkottai[CRU]
Ahmedabad
Palayamkottai[SMPU]
Bangalore
10 16 13
CCRAS
Institutes
Collaborating
Institutes
Research Area
Central
Research
Institute,
Mumbai
TATA Cancer
Research Institute
•Effect of Ayush-QOL-I in
operable stage III and IV Non
Small Cell Lung Cancer – in
process
Central
Research
Institute,
Mumbai
Grant Medical
College & J.J.
Hospital, Mumbai
Improvemnt of quality life
in AIDS/HIV patients
(Ayush QOL-2)
CCRAS
Institutes
Collaborating
Institutes
Research Area
Central
Research
Institute,
Mumbai
IIT, Mumbai
Central Regional
Research Institute,
Nagpur
Govt. Medical College
& Hospital, Nagpur
Sickle cell Anaemia
Physico-chemical structure –
bio availability - use for
standardizing Bhasma
equivalent products
1
6
1
7
CCRAS, Hqs. National Centre for
Antarctic & Ocean
Research, Vasco-da-
gama, Goa.
Antarctic expedition on effect of certain
Ayurvedic Rasayana food supplements &
drink on process of aging in cold climatic
conditions
1
8
CCRAS Hqs.
(Funded by
Dept. of Family
Welfare)
NIPER (CSIR),
Mohali
Standardization, Shelf Life, Stability,
Biological Activity , Bio Availability Studies,
Estrogen Receptor Assay of Pippalyadi Yoga
Capsule - A Female oral contraceptive.
1
9
CCRAS Hqs. CRI,
Kolkata
Prof. Asima Chatterjee, UGC
Centre Advanced Studies-
Natural Products, Kolkata
University
Effect of Pongamia pinnataEffect of Pongamia pinnata
Wrightia tinctoria on Psoriasis vulgaristinctoria on Psoriasis vulgaris
CRI, New
Delhi
IIT, New Delhi Designing Panchakarma Equipments
1
6
1
7
RRI,
BANGALORE
Sports Authority
Of India ,
Bangalore center
Effect of Poshak Yog on General
health of trainee Atheletes
1
8
CCRAS, Hqs  Dept. of
Pharmacology
Punjab University,
patiala
Collaborative Studies for Alzheimer's
disease & parkinsonism
1
9 CCMB
HYDERABAD
CCRAS HQS
Amul Diary
Anand Gujrat
National
Institute OF
Nutrition
Development of Neutraceuticals
–School children, pregnant
ladies, geriatric group
CCRAS,
Hqs
Evaluation of Ayush CT drops in
developmental stages of cataract
Multi-centric Clinical Trial of Ksharasutra (Ayurvedic
Medicated Thread) in the Management of Fistula in-Ano
Therapy :- Ksharasutra
Findings : *In this OPD procedure Cutting and Healing took
place simultaneously so that no raw area was left
*No recurrence has been reported.
*Minimal tissue damage and less pain.
•New formulation Ayush G Sutra is being developed and
validated for its efficacy with appropriate protocols, parameters
B.D. Kulkarni. INSTITUTE OF GENOMICS &
INTEGRATIVE BIOLOGY,
CBME – IIT,DELHI
(SUPPORT ENCOURAGEMENT.)
B.D. Kulkarni.
1. Patenting of AYUSH-56 – An Anti-Epileptic Drug
2. Patenting & launching of AYUSH-64 –Anti malarial drug
3. Patenting of 777 Oil – A Siddha drug for Psoriasis
4.Inclusion of AYUSH GHUTTI & BAL RASAYAN
developed by CCRAS in 12 selected formulations of
Ayurveda & Unani for
Reproductive &Child Health Care Programme ,
Government of India.
5. Signing of Memorandum of Understanding with
1.AYUSH –Ayurvedic Pharmacopoeia Commission
2.Golden Triangle Projects [G.T.P] validate Ayurvedic Produc
3.Standardization of Ayurvedic Education
4.Support to Ayush Drugs Industries
5.More Focus on Collaborative Research in Ayurveda.
6.Initiative for Global promotion of Ayurveda
7.Continuation of TKDL Project to safe guard patents
8Publication of Pharmacopoeial standards
9Publication of Formularies and Essential Drug Lists.
101nforcement of GMP
11 Scheduled list of poisonous materials.
12.Validation of traditional medicines for safety & efficacy.
Good Manufacturing Practices (GMP) enforced 2003.
Ayurveda -Traditional Bio-diversity Act.
Wild Life Protection Act.
Indian Forests Act.
Law of practice I.M.C.C. ACT 1970
Registration of practitioners mandatory.
& requires possession of recognized qualification.
Licensing of manufacturing units & drugs mandatory
Government Drug Analysts-Qualifications &Duties.
Good Laboratory Practices.
Appointment of Drug inspectors.
Increased support for ISM
Main streaming ISM
Creating evidence for safety, efficacy & authenticity .
Regulation fr herbal medicine, protection: endngered spice
Support data collction, preservtion of tradtional knowledge
Publication of monographs on herbs
National Accreditation Board For Hospitals & Healthcare
Providers –NABH for AYUSH hospitals
Proper utilization of technology, talent, traditional
knowledge to achieve health for all by judiciously
following all guidelines out lined.
Standardization
enhanced quality of education of ISM personal .
Scientifically high standards of drug manufacturing
Evidence based therapeutics ,global standard research in ISM
Globalization has changed us into a company that searches
the world ,not just to sell or to source, but to find intellectual
capital the world’s best talents & greatest ideas.
A potent poison becomes the best drug on
proper administration.
On the contrary, even the best drug
becomes a potent poison if used incorrectly.
Without standardization ISM becomes
a bane and not boon to mankind.
Standardization of ism practices

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Standardization of ism practices

  • 1.
  • 2. “If you think of standardization as the best that you know today, but which is to be improved tomorrow; you get somewhere.” Globalization is not only something that will concern & threaten us in the future, but something that is taking place in the present & we need to be aware of it now.
  • 3. Globalization Standardization: physician, medicine ,nursing, patient Education: graduation, post graduation, research…… Drug standardization ,cultivation-manufacturing… Evidence based management protocols, research…. Government policies -regulations
  • 4. Ayurveda: Indian system of medicine ;more than 5000 years old ,holistic, personalized, traditional, time tested since centuries Yoga –Astanga – yama-niyama-Asana-pranayama-pratyahara- dhyana-dharana –samadhi .Not a cult or physical practice. Unani – has own principles, very similar to Ayurveda,UNAN Siddha –specialized Ayurveda medicine, more Rasaoushadhi Homeopathy –simili simlipus curantum –Dr.Hanneman Traditional –folklore –bone setters, midwives, snake poison-…. Medical pluralism is accepted in India
  • 5. Physician Medicaments Care giver / nurse Patient response/obedience
  • 6. Standardization of Ayurvedic Education 3 National institutes, universities Gujarat, Banaras, Jaipur, New Delh Many colleges imparting AYUSH courses.
  • 7. Fix standards - education, syllabi & course curricula, requirements of hospitals, faculties, equipment, clinical exposure, examination pattern;  to ensure adherence to laid down standards above  to maintain a Central Register of practitioners; Recommend to Central Government for recognition / withdrawal of medical qualifications awarded by Universities;  to lay down code of conduct, ethics and etiquette o practitioners.
  • 8. Herb cultivation -seed to sapling, land to lab –quality control Good manufacturing practices & Good lab practices National Medicinal plant board –central ,regional, Drugs & cosmetics act Ayurveda –siddha –Unani (ASU) Drug technical advisory board & consultative committee ) Pharmacopoeial Laboratory for Indian Medicine (PLIM WHO ,FAO (food & agricultural organisation) rules. Finished products specification ,(FPS), MHRA, USFDA
  • 9. Color, appearance, odor, taste, hardness, clarity…… Limit tests, extractive values, chemical assays ….. Viable content, total mold count, total bacterial count…. Chromatographic & spectroscopic evaluation -LC,HPTCL, HPLC methods, TLC fingerprint evaluation herbals (FEH Determination of heavy metals Pesticide residue ,radio active contamination….
  • 10.
  • 11. Herbal cultivation Procurement, preservation, packaging raw material. Good manufacturing practices of herbal-herbo mineral formulations. Intensive quality control protocols at all levels of manufacturing AYUSH parks, clusters created
  • 12. New Delhi A y u r v e d a S i d d h a C e n t r a l R e s e a r c h i n s t i t u t e A y u r v e d a S i d d h a R e g i o n a l R e s e a r c h i n s t i t u t e A y u r v e d a S i d d h a R e s e a r c h U n i t s / C e n t r e s C C R A S Patiala Cheruthuruthy Junagarh Jaipur Kolkata Mumbai Gwalior Lucknow Bhubneshwar Patna Chennai Trivandrum ALRCA Pune Tarikhet Hyderabad Gangtok Guwahati Itanagar Bangalore Jammu Mandi Vijayawada Nagpur Jhansi Hastinapur Jamnagar[DSRP] Kottakal Pondicherry Car-Nicobar[THCRP] Leh Chennai Varanasi[DSRP] Jamnagar[MCRU] Palayamkottai[CRU] Ahmedabad Palayamkottai[SMPU] Bangalore 10 16 13
  • 13. CCRAS Institutes Collaborating Institutes Research Area Central Research Institute, Mumbai TATA Cancer Research Institute •Effect of Ayush-QOL-I in operable stage III and IV Non Small Cell Lung Cancer – in process Central Research Institute, Mumbai Grant Medical College & J.J. Hospital, Mumbai Improvemnt of quality life in AIDS/HIV patients (Ayush QOL-2)
  • 14. CCRAS Institutes Collaborating Institutes Research Area Central Research Institute, Mumbai IIT, Mumbai Central Regional Research Institute, Nagpur Govt. Medical College & Hospital, Nagpur Sickle cell Anaemia Physico-chemical structure – bio availability - use for standardizing Bhasma equivalent products
  • 15. 1 6 1 7 CCRAS, Hqs. National Centre for Antarctic & Ocean Research, Vasco-da- gama, Goa. Antarctic expedition on effect of certain Ayurvedic Rasayana food supplements & drink on process of aging in cold climatic conditions 1 8 CCRAS Hqs. (Funded by Dept. of Family Welfare) NIPER (CSIR), Mohali Standardization, Shelf Life, Stability, Biological Activity , Bio Availability Studies, Estrogen Receptor Assay of Pippalyadi Yoga Capsule - A Female oral contraceptive. 1 9 CCRAS Hqs. CRI, Kolkata Prof. Asima Chatterjee, UGC Centre Advanced Studies- Natural Products, Kolkata University Effect of Pongamia pinnataEffect of Pongamia pinnata Wrightia tinctoria on Psoriasis vulgaristinctoria on Psoriasis vulgaris CRI, New Delhi IIT, New Delhi Designing Panchakarma Equipments
  • 16. 1 6 1 7 RRI, BANGALORE Sports Authority Of India , Bangalore center Effect of Poshak Yog on General health of trainee Atheletes 1 8 CCRAS, Hqs  Dept. of Pharmacology Punjab University, patiala Collaborative Studies for Alzheimer's disease & parkinsonism 1 9 CCMB HYDERABAD CCRAS HQS Amul Diary Anand Gujrat National Institute OF Nutrition Development of Neutraceuticals –School children, pregnant ladies, geriatric group CCRAS, Hqs Evaluation of Ayush CT drops in developmental stages of cataract
  • 17. Multi-centric Clinical Trial of Ksharasutra (Ayurvedic Medicated Thread) in the Management of Fistula in-Ano Therapy :- Ksharasutra Findings : *In this OPD procedure Cutting and Healing took place simultaneously so that no raw area was left *No recurrence has been reported. *Minimal tissue damage and less pain. •New formulation Ayush G Sutra is being developed and validated for its efficacy with appropriate protocols, parameters
  • 18. B.D. Kulkarni. INSTITUTE OF GENOMICS & INTEGRATIVE BIOLOGY, CBME – IIT,DELHI (SUPPORT ENCOURAGEMENT.) B.D. Kulkarni.
  • 19. 1. Patenting of AYUSH-56 – An Anti-Epileptic Drug 2. Patenting & launching of AYUSH-64 –Anti malarial drug 3. Patenting of 777 Oil – A Siddha drug for Psoriasis 4.Inclusion of AYUSH GHUTTI & BAL RASAYAN developed by CCRAS in 12 selected formulations of Ayurveda & Unani for Reproductive &Child Health Care Programme , Government of India. 5. Signing of Memorandum of Understanding with
  • 20. 1.AYUSH –Ayurvedic Pharmacopoeia Commission 2.Golden Triangle Projects [G.T.P] validate Ayurvedic Produc 3.Standardization of Ayurvedic Education 4.Support to Ayush Drugs Industries 5.More Focus on Collaborative Research in Ayurveda. 6.Initiative for Global promotion of Ayurveda 7.Continuation of TKDL Project to safe guard patents 8Publication of Pharmacopoeial standards 9Publication of Formularies and Essential Drug Lists. 101nforcement of GMP 11 Scheduled list of poisonous materials. 12.Validation of traditional medicines for safety & efficacy.
  • 21. Good Manufacturing Practices (GMP) enforced 2003. Ayurveda -Traditional Bio-diversity Act. Wild Life Protection Act. Indian Forests Act. Law of practice I.M.C.C. ACT 1970 Registration of practitioners mandatory. & requires possession of recognized qualification. Licensing of manufacturing units & drugs mandatory Government Drug Analysts-Qualifications &Duties. Good Laboratory Practices. Appointment of Drug inspectors.
  • 22. Increased support for ISM Main streaming ISM Creating evidence for safety, efficacy & authenticity . Regulation fr herbal medicine, protection: endngered spice Support data collction, preservtion of tradtional knowledge Publication of monographs on herbs National Accreditation Board For Hospitals & Healthcare Providers –NABH for AYUSH hospitals
  • 23. Proper utilization of technology, talent, traditional knowledge to achieve health for all by judiciously following all guidelines out lined. Standardization enhanced quality of education of ISM personal . Scientifically high standards of drug manufacturing Evidence based therapeutics ,global standard research in ISM
  • 24. Globalization has changed us into a company that searches the world ,not just to sell or to source, but to find intellectual capital the world’s best talents & greatest ideas. A potent poison becomes the best drug on proper administration. On the contrary, even the best drug becomes a potent poison if used incorrectly. Without standardization ISM becomes a bane and not boon to mankind.