Indian GCP Guidelines

• Evolved with consideration of WHO, ICH, USFDA , European GCP and Ethical Guidelines of Biomedical Research on Human Subjects of ICMR.
• Should be followed for carrying out biomedical research in India at all stages of drug development,whether prior or subsequent to product registration in India

Ethical Principles of Indian GCP:

Essentiality, Voluntariness, Informed consent and community agreement, Non-exploitation, Privacy and confidentiality , Precaution & risk minimisation , Professional competence, Accountability and transparency, Maximisation of the public interest and Distributive justice, Institutional arrangements , Public domain Totality of responsibility,  Compliance

Declaration of Helsinki 1964

• Duty of physician to protect the life, health, privacy and dignity of the human subject
• Review of proposed research by independent ethics committee
• Medical research involving human subjects only by scientifically qualified persons and under the supervision of a clinically competent medical person
• Physician to obtain the subject’s freely-given consent, preferably in writing
• Stress on publication of results - negative or positive

Nuremberg Code

Nuremberg Code(1947)

• Voluntary consent
• Anticipate scientific benefits
• Benefits outweigh risks
• Animal experiments first
• Avoid suffering
• No intentional death or disability
• Protection from harm
• Subject free to stop
• Qualified investigators
• Investigator will stop if harm occurs