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