Transcript Intersyste Bioedica

Establishment of an Intersystem Ethics
Committee & Capacity Building of EC
members & of applicants
Intersystem Biomedica Ethics
Committee , Mumbai
Dr Jayashree Joshi, Member Secretary
FERCI Conference, TMC, Mumnbai,
Mumbai,2011
Late Dr Arun Sanghani
Founder Chairman
FERCI, Mumbai,2011
AYURVED
ALLOPATHY
SIDDHA
ISBEC
UNANI
HOMEOPATHY
YOGA
NUTRITION
FERCI, Mumbai,2011
Mission
• To function as an independent ethics committee for
encouraging scientific progress of various systems
of medicine
• To inter exchange ethical values amongst
various systems
• To collaborate with the ICMR, CSIR, AYUSH, CCRAS
FERCI, Mumbai,2011
Objectives
• To formulate guidelines for research in
inter system research
• To guide the industry in clinical
trials
• To undertake training in Research
Ethics in clinical medicine
Highlights of ISBEC SOPs
Intersystem Biomedica Ethics Committee
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ICH GCP Guidelines
ICMR guidelines
FERCI Guidelines
WHO Guidelines
FDA
DCGI Guidelines
Homeopathy
FERCI, Mumbai,2011
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Charaka Samhita
Sushruta Samhita
Ashtanga Hridaya
Sharangdhar Samhita
Vaidyak- SadvrittaSadachar
Unani
ISBEC –categories of applicants:
1) Multinational companies
2) Governmental Research Organisations like ICMR,
DBT, CCRAS, CSIR
3) Postgraduate students’ dissertations for MSc or
PhD
4) Clinical trials by Clinical Research Organisations
5) Projects from Ayurvedic CROs
6) Questionnaire surveys by voluntary organisations,
national professional bodies or Pharmaceuticals
FERCI, Mumbai,2011
Review Process
Application from Investigator, CRO, Student Expedited review
1 st wk
Primary
reviewer +
Other
members
Primary
reviewer +
Other
members
ISBEC Meeting
4th wk
Suggestions / Rejection
FERCI, Mumbai,2011
Special Meeting
Suggestions /
Rejection
Modified protocol submitted
Approval letter issued with a validity date
Types of Diseases
• Asthma – Phase II-Comparative with placebo
• DM- Phase I – antisecretory compound- use of placeboPhase
Phase IV-multicountry; Ayurvedic - for multicentric
studies
• TB –Existing approved product-Multinational Co
• I H D- Homeopathy- Total revision of protocol
• Malaria
• Leucorrhoea, Menorrhagia
• Neurogenic pain
FERCI, Mumbai,2011
Range of Topics for studies
More than 80 projects evaluated
FERCI, Mumbai,2011
• New molecules for DM, BPH - NCEPhase 1, 2
• PKPD studies
• Phase 3 studies- DM, Arthritis
• New indications for a drug or vitamin
• Pilot studies- Ayurved based
• Questionnaire surveys
• Nutrition- analysis of foodgrains
• Nutrition- anthropometry
• Nutrition education
• Herbal/ Ayurveda based
• Dietary interventions- genetically
selected foodgrains
Review of ADRs & Action Taken
• Hepatotoxicity in CSIR-NMITLI project- wrongly
attributed to the herbal product
• Gastrointestinal side effects – wrongly attributed
to herbal product
• Injectable product for neurological pain reliefmultinational study - consent form modified as
per the recommendation
Dissemination of Intersystem values
& principles
• Full Day ICMR supported Seminar - proceedingspublished- ISBEC, ICMR, Industry, academia
• Half Day- Seminar – FERCI President ,ISBEC, MRC-KHS
participation
• ICMR Reverse Pharmacology Training Workshopsession on ethics in researchAyurvedic, allopathic,
basic scientists-delegates from all over India
• Chapter on clinical trials in pregnant & lactating women
FERCI, Mumbai,2011
Future Plans
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FERCI, Mumbai,2011
Training
Seminars
Workshops
Monitoring
Thank You !
FERCI, Mumbai,2011