The BioMedical Ethics Committee

The BioMedical Ethics Committee (BMEC) is India's first independent ethics committee, set up under the aegis of Apothecaries Foundation.  Constituted according to the laws of the land and operating in compliance with the best international practices. Apothecaries Independent Ethics Committee has been undertaking review of research protocols and continued review for any Investigators and Trial Site that choose to avail its services.

The BMEC has been operating with the objective of facilitating clinical research particularly:

  • in institutions which do not have a GCP compliant Ethics Committee

  • in institutions seeking additional ethics review of clinical research projects

  • by Investigators who are not affiliated to major medical institutions

  • academic researchers

The BMEC strives TO BE

  • Concerned about safeguarding the rights, safety and well being of study subjects and patients

  • Responsible and accountable to researchers by offering efficient and swift reviews

  • Responsive to researchers’ and study subject’s needs

  • Objective

  • Systematic

  • Balanced and fair

  • Having faith in the dignity and professionalism of researchers and sponsors

  • Gate keepers for ethics in research

  • Independent, credible, dignified and financially viable

  • Open to others’ ideas and concepts

  • Compliant with contemporary Indian and international requirements for ethics review

The BMEC strives NOT TO BE

  • Concerned about issues extraneous to bio-medical ethics

  • Operating at our own convenience, pace, preferences or priorities

  • Overbearing or overzealous

  • Unpredictable, capricious or alarmist

  • Bureaucratic

  • Skewed towards study subjects or researchers

  • Suspecting them of malice or misdeeds

  • Road blocks in research

  • Dependent upon anyone to fund operations or growth

  • Rigid about point of views

  • Autocratic

The BMEC believes that good Sponsors have a very high stake in ethics & science. They have no use for incredible data generated by unethical research.
Anyone conducting research in India can avail of our services.

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CDSCO – the India’s Regulatory Authority issued an order on July 30, 2013 (ECR/Misc/Indt EC/007/2013) stating “no new clinical trial shall be reviewed and approved by… independent ethics committees.” The BMEC has since then has ceased reviewing protocols for clinical trials involving new drugs.  The BMEC believes that sooner than later - better wisdom shall dawn and prevail in this regard.

The Foundation is holds itself responsible and accountable to the public, and remains available to clinical research participants subjects to review their grievances and to intervene where necessary.

 

Administrative Office: 876 Udyog Vihar Phase V, Gurgaon, Haryana 122016, India.

Registered Office: 39 Silver Oak Farms, 446/1 Ghitorni, New Delhi 110030, India.