Thought Leadership

Independent Ethics Committee

The Foundation has set up an Independent Ethics Committee "The BioMedical Ethics Committee" constituted according to the laws of the land and operating in compliance with the best international practices. Apothecaries Independent Ethics Committee shall undertake to review research protocols and take the responsibility of continuing review for any Investigator or trial site which wishes to avail of its services.

The BioMedical Ethics Committee an independent ethics committee constituted 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
    <<Link of website to be given>>

Good Pharmacy Practice Guidelines

Dr. Brijesh Regal created Good Pharmacy Practice (GPP) Document in March 2002, while working as Chairman of Community Pharmacy Division of Indian Pharmaceutical Association. This document was prepared to set a basic standards of working for Indian pharmacists. GPP created by Dr. Brijesh Regal, is a first of its type published so far. <<PDF of the document to be linked>>

Schedule Y and Indian GCP Guidelines

Dr. Brijesh Regal coordinated the evolution and documentation of Indian regulations for conducting clinical research (Schedule Y), Indian GCP Guidelines and BA-BE study Guidelines while working as WHO Consultant to Drug Controller General of India (1999-2004), which catalyzed the renaissance of clinical trials in the country.

Regulations were notified in 2005, and provided a major impetus to global clinical research in India.

National Pharmacovigilance Programme

Dr. Brijesh Regal has  conceptualized the National Pharmacovigilance Program and has been a member of the National Pharmacovigilance Advisory Committee.
<< Link to Pharmacovigilance Protocol>>

BSL-3 Microbiology Lab

Apothecaries Foundation created India's first TB dedicated BSL-3 compliant lab with genetic mapping

BE Study Facility

Set up country's first CDSCO approved BA/BE study facility & conducted 40+ studies of almost all therapeutic areas

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.