ICH & ICMR

KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Subject : Modern bio analytical techniques
Topic : ICH Guidelines and ICMR Guidelines
Presented By,
VENKATESAN R
(Reg No : 22PA023) (2nd Sem)
M. Pharm Pharmaceutical analysis,
Presented to,
Dr. Harsha K Tripathy,
Department of Pharmaceutical analysis

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Content:
• Guidelines of ICH
• Guidelines of ICMR
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1. ICH
• Definition:
International Council for Hormonization of technical
requirements for pharmaceutical for human use.
Regulatory authorities Pharmaceutical Industry
ICH Bring together
to scientific and technical aspects of drug registration
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ICH is a joint initiative involving both the regulators and the industry
as equal partners in the scientific and technical discussions of the
testing procedures which are required to ensure and assess the safety,
quality and efficacy of medicines.

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The ICH topics are divided into four categories and ICH topic codes are assigned
according to these categories.
1. Efficacy (E1-E20):
clinical trials etc
2. Safety (S1-S11):
pharmacovigilance, adverse drug reaction reporting
3. Quality (Q1-Q14):
raw materials, impurities, residual solvents etc
4. Multidisciplinary (M1- M12):
common technical document, electronic submission, coding systems.
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ICH Member / Parties:
6 parties
• EU
• EFPIA (European federation of pharmaceutical industries Associations)
• MHLW (Ministry of health, Labor and welfare), Japan
• JPMA (Japan Pharmaceuticals manufacturers Association)
• US FDA
• PhRMA ( Pharmaceutical Research and Medical Association)
• Observers : WHO, TPP (canada)
• International federation of Pharmaceutical manufacturer’s association
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ICH GCP guideline
1. Glossary:
Common language for investigators/sponsors/ethics committees
2. Principles of Good Clinical Practice:
13 tenets of ICH GCP
3. Requirements for IRB/IEC
Roles responsibilities and composition
4. Responsibilities of the investigator
5. Responsibilities of the sponsor
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6. Requirements for clinical trial protocol
and protocol amendments
7. Responsibility of the sponsor in the development of investigator’s
brochure.
8. Essential documents.
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GCP STORY
GCP

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Good Clinical Practices (GCP) is an international ethical &scientific
quality standard for designing, conducting, recording &reporting
trials that involve the participation of human subjects.
• To ensure the rights, safety and well being of the trial subjects are
protected.
• Ensure the credibility of clinical trial data.
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1. ICMR -Indian Council of Medical Research
• One of the oldest medical research body in the world ICMR, New
Delhi.
• It is national agencies for planning, formulation, co-ordination,
implementation.
• In 1911, government of india set up the Indian research fund association
sponsoring and co ordinating medical research in country.
• After independence, several important changes made in IRFA.

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• It was redesigned the ICMR in 1949 with expanded scope of function
and responsibilities
• ICMR funded by Government of india through Ministry of Health,
Family and welfare.
• It is not only planning and promoting it build strong national group.
• Rapid advances in science and technology have brought in new
technologies to understand the disease process and find strategies for
prevention and cure.
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Guidelines:
• Guidelines on transfer of human biological material for research
• Dietary guidelines for Indians.
• Cancer management guidelines.
• Guidelines for good clinical laboratory practices.
• Ethical guidelines for biomedical research on human participants.
• Control and management of communicable disease, facility control,
maternal and child health.
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Objective:
ICMR, with its 30 state of the art institutes/centers, is amongst
research organizations in the field of bio medical sciences.
• The Indian council of medical research provides financial assistance to
promote biomedical and health research.
• Proposals in fundamental research, development and evaluation of a tool,
clinical and operational research are considered for ICMR support.
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Indian Council of Medical Research
Abbreviation ICMR
1. Type Professional Organization
2. Headquarters New Delhi
3. Region served India
4. Secretary and director general Dr. V. M. Katoch
5. Website http://www.icmr.nic.in/
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Intramural Research
Intramural research is carried out currently through the council’s 30
research institutes/centers.
These includes,
1. 19 mission oriented national institutes.
2. 6 Regional Medical Research centers.
3. 5 Units/Centers
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Extramural research
Extramural research is promoted by ICMR though setting up
• Centres for advanced research in selected departments of medical colleges,
universities and other non-ICMR research institites.
• Task force studies with goal oriented approach with clearly defined targets.
• Open ended research in non ICMR research institutes, medical colleges,
universities etc. located in different parts of the country
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Fellowship and schemes
The ICMR encourage human resources development in biomedical
research through various schemes such as
1. Research fellowships
2. Short term visiting fellowships
3. Short term research studentships
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4. Various training program and workshops conducted by ICMR
institutes and headquarters.
National Health Programmes:
• National Malaria eradication programme
• National Filaria control Programme
• National leprosy control programme
• Diarrhoeal disease control programme
• National AIDS control programme
• National cancer control programme
• National tuberculosis programme
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ICH & ICMR

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