August 23rd, 2024: A recent study conducted by a team of international researchers from the Newcastle University, the Indian Institute of Public Health - Delhi, Queen Mary University of London and others has shed light on the growing concerns regarding the sale and regulatory status of Fixed Dose Combination (FDC) psychotropic drugs in India. The study, titled "Sales and Regulatory Status of Fixed Dose Combination Psychotropic Drugs in India: A Retrospective Longitudinal Study," was published in the Journal of Pharmaceutical Policy and Practice.

The study revealed a significant increase in the sales volume of psychotropic FDCs in India, from 0.8 billion standard units (SUs) in 2008 to 1.4 billion SUs in 2020. Despite this growth, a substantial portion of these drugs remains unapproved by central regulatory authorities.

In 2008, unapproved psychotropic FDCs accounted for 69.3% of sales. Although there was a slight decrease to 60.3% by 2020, the majority of psychotropic FDC sales continue to involve drugs that have not been evaluated for safety and efficacy.

The study examined the impact of two key government regulatory initiatives aimed at controlling unapproved FDCs. Despite these efforts, the initiatives have had limited success, with only three of the 21 psychotropic FDCs targeted under these regulations being banned, and two of these still available on the market in 2020.

The findings raise significant public health concerns, as the widespread availability and use of unapproved psychotropic FDCs pose potential risks to patients due to the lack of safety and efficacy evaluations. The study's authors call for stricter regulatory enforcement and comprehensive evaluations of FDCs to protect public health.

Study author, Dr Aashna Mehta, Indian Institute of Public Health, added: “The presence of several unapproved FDCs on the Indian market despite the efforts of the government to weed them out over the years is problematic. A key issue is that of division of responsibility between the center and state. FDCs often reach the market based on licenses granted by state licensing authorities without obtaining necessary approvals from CDSCO, the central authority which is supposed to provide clearance for all new drugs including FDCs.”

 About the Study:

This research was a collaborative effort involving experts from Newcastle University, the Indian Institute of Public Health - Delhi, Queen Mary University of London, and other leading institutions. The study utilized data from the PharmaTrac database, covering sales from 2008 to 2020, and regulatory documents from both Indian and international sources.

About the Journal of Pharmaceutical Policy and Practice:

The Journal of Pharmaceutical Policy and Practice is a peer-reviewed publication dedicated to the dissemination of research and knowledge in the field of pharmaceutical policy, practice, and regulation. The journal is committed to providing a platform for the exploration of issues related to the development, regulation, and use of pharmaceuticals globally.

ABOUT NEWCASTLE UNIVERSITY: Newcastle University, UK, is a thriving international community of more than 28,000 students from over 130 countries worldwide. As a member of the Russell Group of research-intensive universities in the UK, Newcastle has a world-class reputation for research excellence in the fields of medicine, science and engineering, social sciences and the humanities. Its academics are sharply focused on responding to the major challenges facing society today. Our research and teaching are world-leading in areas as diverse as health, culture, technology and the environment. Newcastle University is committed to providing our students with excellent, research-led teaching delivered by dedicated and passionate teachers. Newcastle University is ranked 110th in the QS World Ranking 2024 and 139th in the Times Higher Education World University Ranking 2023.