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 lead author, Dr Paul Bogowicz, Consultant Child and Adolescent Psychiatrist, said: “We don’t know whether unapproved psychotropic FDCs will help the person taking them. They could also cause significant side effects, which could lead to a worse quality of life overall. There may also be risks associated with stopping such drugs and so anyone wanting to stop taking them should speak to their doctor first.”
Professor Allyson M. Pollock, Clinical Professor of Public Health at Newcastle University and one of the lead researchers of the study, commented: “The continued dominance of unapproved psychotropic FDCs in the Indian market is alarming. Our study highlights the urgent need for stronger regulatory oversight and enforcement to ensure that these drugs are safe and effective for patients.”
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.”
Notably, 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.
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