BIO-ETHICS

BySROTA DAWN

M.PHARM(PHARMACOLOGY)

INTRODUCTION:

The term bioethics formed by two different words

Biology+

EthicsBiology :

The scientific study of life and of living organisms.Ethics :

A set of principles of right conduct.Motivation based on ideas of right and

wrong

Definition of Bioethics

Bioethics is defined as the study of the ethical and moral implications of new biological discoveries and biomedical advances; mostly in the fields of genetic engineering and drug research.

In medicine, it can be found in Hippocratic Oath which was first

mentioned in ancient GreeceActual meaning of Bioethics [Greek ]  bios ~ life;  ethos~ behavior)

Why we need bioethics

• deciding what we should do (what decisions are morally right or acceptable);

• explaining why we should do it (how do we justify our decision in moral terms);

and

• describing how we should do it (the method or manner of our response when we act on our decision).

Ethics

BioethicsClinical Ethics

Research ethics

Resource Allocation ethics

Public Health ethics

Nursing ethics

other

Business ethics

Environmental ethics

Social ethics

Organizational ethics

IT ethics

Other

Research ethics

Preclinical study related ethics

Clinical study related cthics

Preclinical research

After synthesising/identifying a prospective

compound(s), it is tested on animals to

expose its whole pharmacological profile.

It is an evaluation process where unfavourable compounds are get rejected in each step, so that only a few out of thousand compounds reach the stage when administration to man (clinical study) is considered.

Parameters to be checked in preclinical studies(GLP)

• Screening tests• tests on isolated organs, bacterial cultures• test on animal models of human disease• general observational test• confirmatory tests• mechanism of action• systemic pharmacology• quantitative tests• pharmacokinetic studies• toxicity tests• acute• Sub acute• Chronic• special long term toxicity• reproductive toxicity and teratogenicity• mutagenicity• carcinogenicity

Laboratory animalRodents Mouse

Rat

Guinea pig

Hamster

Rabbit

Larger animalCat

Dog

Human primates

Legal regulations for the use of animals in preclinical study

‘Russel and Burch’

In their book

‘ The Principles of humane experimental technique ’

(1959)Gave a concept of

three ‘R’s

Reduction Refinement

Replacement

in INDIA PREVENTION OF CRUELTY TO ANIMALS ACT 1960

Is provided for animal safety during clinical studies

CPCSEA was established under that provision

CPCSEA is the

COMMITTEE FOR THE PURPOSE OF CONTROL AND SUPERVISION OF EXPERIMENTS ON ANIMAL

UTILITY OF CPCSEA

These guidelines provide a clear idea about the use of animals during experiments using animals.

All labs doing animal work had to be registered with the CPCSEA and had to follow a set of rules.

The main criteria of this committee is

‘TO PROMOTO HUMANE CARE OF ANIMALS USED FOR EXPERIMENTS’

It provides specifications that will enhance Animal well being

members

• 1 person from ICMR

• 1 person from ICAR

Draft committee members

• 1 person from biotechnology• 1 person from NATIONAL

INSTITUTE OF BIOTECHNOLOGY

• 1 person from CENTRAL DRUG RESEARCH INSTITUTE1 person from INDIAN INSTITUTE OF SCIENCE

• 1 Person from ALL INDIA INSTITUTE OF MEDICAL SCIENCE

• 1 person from INDIAN VATENARY RESEARCH INSTITUTE

• 1 person from RANBAXY INDIA LIMITED

• Director of department of biotechnology

CPCSEA COMMITTEE MEMBERS

Hon. Smt. Maneka Ghandhi (chairperson)Subcommittee members

CPCSEA guidelines

1. Veterinary care2. Animal procurement3. Quarantine, stabilization and separation of animals4. Animal experiments using hazardous chemicals5. Multiple surgical procedures on single animal6. Duration of experiments7. Physical restraint8. Physical plant 9. Physical relationship of animal facilities to

laboratories10.Functional areas11.Physical facilities12.Environment13.Animal husbandry• Caging or housing system• Sheltered or outdoor housing• Social environment14.Activity15.Food16.bedding

17.Water18.Sanitization and cleanliness19.Assessing the effectiveness of sanitization20.Waste disposal21.Pest control22.Emergency, weekend and holiday care23.Record keeping24.Standard operating procedures25.Personal training26.Transport of laboratory animals27.Anaesthesia and uthanesia

Clinical trials

when a compound shows significant response in all the tests done in preclinical studies the regulatory authority approaches for investigational new drug(IND)licence.

Synthesis/isolation of new molecule

purification

Preclinical studies

IND submission to WHO

WHO approval

Formulation of dosage form

Clinical study in man

Clinical trialPhase IHUMAN PHARMACOLOGY

AND SAFETY

Phase IITHERAPE

UTIC EXPLORA

TION AND

DODE RANGEIN

G

Phase IIITHERAPE

UTIC CONFORMATION

AND COMPARI

SON

Phase IVPOST

MARKETING

SERVEILLANCE

Thank you