Clinical Research Academy
Apothecaries Foundation is making earnest efforts to provide leadership and direction towards inculcating Good Clinical Practice (GCP) culture in Biomedical research in India. The training courses have been planned by the Foundation to foster GCP culture in Indian clinical research environment.
Apothecaries Foundation through Clinical Research Academy (an organ of Apothecaries Foundation) has conducted more than 200 Good Clinical Practice training courses for clinical research professionals e.g. clinician, surgeons, pharmacologist, nurses, pharmacists, laboratory technicians etc.
Apothecaries Foundation has conceptualized 4 editions of White Book for Clinical Research so far. It has unique character of being compact yet comprehensive hand book for most of the commonly referred guidelines & regulation by the clinical research practitioners worldwide.
Apothecaries White Book contains, Glossary of clinical research terms, Investigators & Ethics Committee FAQs, Schedule Y (Drugs and Cosmetics Rules, Govt. of India), U.S. 21 CFR (Drugs; Parts 50, 54, 56, 312, 314), E.U. Directive (Relating to conduct of clinical trial & some definitions), General Considerations for Clinical Trial (ICH-E8), ICH-GCP Guidelines (ICH-E6), Supervisory Role of Investigator (US FDA Guidance), Clinical Safety Data Management (ICH-E2A), Declaration of Helsinki (World Medical Association), Regulatory Organizations of Various Countries
Study on Extent of Counterfeit Medicines in India
Apothecaries Foundation has conducted a highly scientific study project on Extent of Counterfeit Medicines in India to generate statistically significant data regarding extent of counterfeiting of medicines prevailing in India. The study, possible the first in any country, aims to generate data to help policy makers in dealing with the menace of counterfeit drug.
Presentation on Extent of Counterfeit Medicines in India to Mashelkar Committee
Dr. Brijesh Regal made a presentation to Mashelkar Committee in 2003 on the counterfeit medicines study and the committee not only appreciated the approach but included the recommendations in its final report sent to the Government of India
Book Published: Contemporary Public Health
(Policy, Planning, Management) by Prof. J. P. Gupta & Prof. A. K. Sood
Prof. JP Gupta, a leading public health professional and former Director of the National Institute of Health and Family Welfare, New Delhi, with his long and rich experience in public health at state, national and international level, and Prof. AK Sood have done a commendable job in bringing out this timely publication. It provides a broad and comprehensive coverage of the subject area with judicious mixture of concepts, current issues in public health and grassroots application in terms of management of material, equipment, finances and human resources.
1. Clinical Trial Participants’ Perception Study: “A study of clinical trial participants’ perceptions & experiences in India” organized by
Dr. Sneh Bhargava (former Director of All India Institute of Medical Sciences and Chairman of The BioMedical Ethics Committee, New Delhi) in 2013.
2. Clinical Trial Practitioners’ Perception Study: “Practitioners’ Perceptions of Social Costs & Benefits of Conducting Global Clinical Trials in India” a study instituted by Dr. Saradindu Bhaduri (Associate Professor, Center for Studies in Science Policy, School of Social Sciences, Jawaharlal Nehru University, New Delhi) in November 2015 to collate and analyze the perspectives of civil society, healthcare policy advocates, lawmakers, regulators, investigators and research ethics committees about conducting global clinical trials in India.