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Standardization of ism practices

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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 Delhi

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 of 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 cultivationProcurement, 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

Ayu rveda S id d h a

Cen tral Research in stitu te

Ayu rveda S id d h a

Reg io n al Research in stitu te

Ayu rveda S id d h a

Research Un its/Cen tres

C C R A S

Patiala

Cheruthuruthy

Junagarh

Jaipur

Kolkata

Mumbai

Gwalior

Lucknow

Bhubneshwar

PatnaChennai

TrivandrumALRCA

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

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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

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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.

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CCRAS Hqs. CRI, Kolkata

Prof. Asima Chatterjee, UGC Centre Advanced Studies- Natural Products, Kolkata University

Effect of Pongamia pinnata Effect of Pongamia pinnata Wrightia tinctoria on Psoriasis vulgaris tinctoria on Psoriasis vulgaris

CRI, New Delhi

IIT, New Delhi Designing Panchakarma Equipments

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RRI, BANGALORE

Sports Authority Of India , Bangalore center

Effect of Poshak Yog on General health of trainee Atheletes

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CCRAS, Hqs  Dept. of Pharmacology Punjab University, patiala

Collaborative Studies for Alzheimer's disease & parkinsonism

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CCMB HYDERABAD

CCRAS HQSAmul 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 tookplace 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 DDRI, Chitrakoot for the development of herbal formulations for rural masses (standardization of selected formulations.

1.AYUSH –Ayurvedic Pharmacopoeia Commission 2.Golden Triangle Projects [G.T.P] validate Ayurvedic Product3.Standardization of Ayurvedic Education 4.Support to Ayush Drugs Industries 5.More Focus on Collaborative Research in Ayurveda.6.Initiative for Global promotion of Ayurveda7.Continuation of TKDL Project to safe guard patents8Publication of Pharmacopoeial standards9Publication of Formularies and Essential Drug Lists.101nforcement of GMP11 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 1970Registration 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.