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This article is part of the essay series “World Mental Health Day 2024”
The ability to cope with various stressors, adapt, grow, and contribute to the community is vested in quality mental health. An estimated 970 million people live with a mental health condition globally and it is far from being abated. The COVID-19 pandemic exacerbated anxiety, depression, and mood disorders and also managed to bring about a loneliness epidemic. From a clinical standpoint, there have been increased diagnoses of mental health disorders and drugs often form a significant part of behavioural health management. Mental health has reached a crisis point both in India and across the globe signifying that there is an urgent need to prioritise research and development of therapeutics. Novel drugs that achieve optimal responses through enhanced efficacy and targeted responses are the need of the hour.
Mental health has reached a crisis point both in India and across the globe signifying that there is an urgent need to prioritise research and development of therapeutics.
A concerted effort from multiple stakeholders would ensure that India attains SDG3 by 2030. India’s National Mental Health Survey shows that there exists a treatment gap of at least 80 percent in India. This has been attributed to ‘the poor awareness among people and the availability of limited resources.’ The Government of India has implemented initiatives including the National Mental Health Policy and the Mental Healthcare Act, but there exists a need to address access to efficacious medicines through the development of innovative drugs.
Treating mental health disorders is challenging owing to the vast range of illnesses, the myriad of symptoms, and the highly subjective nature of these diseases. In addition, a sobering actuality in the pharmacological treatment of mental health disorders is that a vast majority of the drugs that are in use today were introduced more than 50 years ago. According to reports, many diseases are treated with limited specificity using a combination of drugs. This indicates that drug development, in the last few decades, has solely focused on improving tolerance and reducing side effects instead of enhancing efficacy. Some disorders, such as major depressive disorder, are treatment-resistant or are unresponsive towards these traditional medicines demonstrating a need for drug discovery.
A sobering actuality in the pharmacological treatment of mental health disorders is that a vast majority of the drugs that are in use today were introduced more than 50 years ago.
Drugs for mental health disorders have historically taken a backseat with the pharmaceutical industry primarily owing to their risk-prone and expensive nature, despite 17 drugs for mental health illnesses being mentioned in India’s National List of Essential Medicines. Novel drug therapies in psychiatry often fail clinical trials chiefly due to redundant clinical responses, the highly subjective nature of appraisal, and a dearth of biomarkers to detect improvements. Endeavours that bridge molecular biology with pharmacology and industrialised drug development were hopeful to produce newer, effective medicines but this did not pan out due to lack of reproducibility of new treatments. In a similar vein, advancements in genomics have not significantly contributed to drug development as most disorders are attributed to multiple genes making the development of targeted therapies extremely difficult.
In addition, pre-clinical studies in animal models are considered highly unreliable as effects are primarily assessed through behavioural changes, which are difficult to translate into human scenarios. For instance, in animal models that have been developed for anxiety and mood disorders, psychiatric symptoms are mimicked through the administration of a drug. These models, however, are said to require a ‘leap of faith’ when researchers attribute an observable change in animals to an emotional response in humans. Collectively, this demonstrates that there have been limitations in drug development.
There is a need to move away from utilising drugs across a spectrum of mental health illnesses as this approach hampers efficacy and patient wellness. Similar roadblocks were encountered during the development of chemotherapeutic agents, which were initially non-specific and broad-based drugs, but detailed research undertakings in cellular and molecular biology enabled a deeper understanding of cancer and targeted therapies have been developed since then.
In animal models that have been developed for anxiety and mood disorders, psychiatric symptoms are mimicked through the administration of a drug.
Similar work could be carried out to develop drugs for conditions such as Alzheimer’s disease, schizophrenia, post-traumatic stress disorder (PTSD), depression, and anxiety as there is a lack of understanding of the underlying pathophysiology. These knowledge gaps impede precise or targeted therapeutic approaches and can be bridged by linking basic research activities to translational research pathways through industry-academic partnerships.
India’s biotechnology industry is booming and is showing great promise in widening its engagement with different healthcare areas. Biotechnology companies are well-poised to engage with the pharmaceutical industry to lead innovative drug development in the mental health sector. Indian startups have ventured into drug discovery and development in other areas, including drugs for malaria, Leishmaniasis, diabetes, and cancer, steering close of possible intellectual property royalties that could be encountered. India’s generic drug manufacturing capabilities contribute to 20 percent of global exports and earn over US$27 billion as of FY 2023-2024. India’s biotechnology market is valued at just over $US100 billion with a CAGR of 11.09 percent for 2024-2033. Cooperation between the biotechnology and pharmaceutical industries can be directed to catalyse drug discovery. Moreover, to stay viable within the market India needs to remain competitive as China has focused considerably on research and development of novel drug candidates with 30 novel drugs approved in 2023 alone. This posits that India can be involved in a riskier and more innovative domain of drug development to address both domestic and global demands.
Research and innovation can be fostered domestically and through international partnerships. India’s BioE3 (Biotechnology for Economy, Environment, and Employment) and Bio-RIDE (Biotechnology Research Innovation and Development Entrepreneurship) policies can foster innovation through collaborative studies to understand the underlying pathologies of diseases. Startup grants through BIRAC (Biotechnology Industry Research Assistance Council) in conjunction with schemes for the pharmaceutical sector, such as PRIP (Promotion of Research and Innovation in Pharma MedTech Sector) can fast-track the process. These ventures will serve as pathways to develop a robust and skilled workforce that contributes to the bioeconomy. In addition, these sectors have voiced a need to use disruptive technologies—GenAI (Generative AI), Artificial Intelligence (AI), and Machine Learning (ML), which can ultimately contribute to rapid drug development and aid in the management of large clinical datasets, respectively.
Biotechnology companies are well-poised to engage with the pharmaceutical industry to lead innovative drug development in the mental health sector.
Collaboration can work on an international scale as well. Taking a cue from Cancer Moonshot—a Quad initiative that aims to combat cancer—India can bridge technical ties with international players to streamline drug development for mental health illnesses. The Department of Science and Technology (DST) holds considerable bilateral arrangements with the United States (US), United Kingdom (UK), France, Germany, and Australia for science and technology development which are prime opportunities for drug discovery research. For instance, US-India cooperation in biotechnology under the partnership between the Department of Biotechnology (DBT) and the US National Science Foundation (US-NSF) or the Indo-US Science and Technology Forum (IUSSTF) could endeavour to explore the production of high-value small molecules of industrial interest that could be applied to mental health illnesses.
Considering the rapid progression of biotechnology and disruptive technologies and the burgeoning pharmaceutical sector, collaborative approaches amongst academia, research organisations, startups, and public-private partnerships (PPP), could pave the way for the rapid production of novel efficacious drugs to address mental health illnesses. Mental health is an aspect of our well-being that deserves noteworthy attention. A one-size-fits-all approach is no longer appropriate to address the wide spectrum of mental health disorders. It is time to usher in an era of innovation and multidisciplinary approaches to produce efficacious drugs to serve a pressing demand.
Lakshmy Ramakrishnan is an Associate Fellow at the Observer Research Foundation
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