New Delhi: For millions of Indians living with persistent anxiety, treatment often involves a combination of counselling and conventional medicines, but many continue to remain untreated because of stigma, poor access to mental healthcare and limited therapeutic options.
In what could broaden the treatment options, the Central Drugs Standard Control Organisation (CDSCO) has approved what is being described as the world’s first fully synthetic cannabidiol (CBD) oral solution for the management of mild-to-moderate anxiety disorders.
The approval marks a significant milestone not only for patients but also for India’s pharmaceutical innovation ecosystem, as the therapy has been researched, developed, patented and clinically evaluated entirely in the country.
The regulator has granted approval to Zenara Pharma, in collaboration with Leiutis Pharmaceuticals LLP, to manufacture the 150 mg/mL synthetic cannabidiol oral solution. The medicine will be available only on the prescription of psychiatrists and is approved to be used alongside cognitive behavioural therapy (CBT), considered the standard psychological treatment for anxiety disorders.
The approval follows successful Phase III clinical trials conducted in India. A Phase IV post-marketing study will now monitor the medicine’s long-term safety and effectiveness in routine clinical practice.
A major unmet mental health need
The approval comes at a time when anxiety disorders are emerging as one of India’s most common mental health conditions. According to the National Mental Health Survey (2015-16) conducted by the National Institute of Mental Health and Neurosciences (NIMHANS), 2.57 per cent of Indian adults suffer from anxiety disorders at any given time, while the lifetime prevalence stands at 3.5 per cent. Based on India’s adult population, experts estimate that more than 2.5 crore people could be living with anxiety disorders.
Despite the high burden, treatment remains inadequate. National surveys have estimated that between 28 per cent and 83 per cent of people with mental illnesses do not receive appropriate care owing to social stigma, shortage of psychiatrists, delayed diagnosis and poor access to mental health services, particularly outside major cities.
Psychiatrists say the availability of another evidence-based treatment option could benefit patients who do not respond adequately to existing medicines or require additional therapeutic choices under specialist supervision.
What makes the approval significant?
The most notable aspect of the approval is that it involves a fully synthetic cannabidiol formulation rather than an extract obtained from the cannabis plant.
Unlike tetrahydrocannabinol (THC), the psychoactive component of cannabis that produces intoxication, cannabidiol (CBD) does not cause a “high”. According to the developers, the approved formulation contains no cannabis plant material and has no abuse or dependence potential associated with psychoactive cannabis products.
This distinction is important because CBD acts on multiple neurological pathways involved in regulating anxiety without producing the euphoric effects linked to recreational cannabis.
The developers also emphasise that the product is not a herbal preparation but a pharmaceutical-grade synthetic molecule manufactured under regulated conditions to ensure consistent quality and dosing.
Entirely developed in India
Leiutis Pharmaceuticals said the approval represents the first global regulatory clearance for a fully synthetic cannabidiol oral solution for anxiety disorders.
The formulation combines a synthetic cannabidiol active pharmaceutical ingredient developed by Biophore India Pharmaceuticals with Leiutis’ proprietary nanodispersible drug-delivery technology designed to improve absorption. Manufacturing will take place at Zenara Pharma’s facilities that comply with Indian and international regulatory standards.
Company officials described the approval as the culmination of nearly a decade of research involving synthetic cannabinoid chemistry, drug-delivery technology, pre-clinical studies and clinical trials.
Industry experts say the development reflects India’s growing capability to move beyond generic medicines towards discovery and development of novel therapies with global relevance.
Not a replacement for psychotherapy
However, mental health specialists have cautioned that the approval should not be interpreted as a standalone solution for anxiety disorders.
The CDSCO approval specifically requires the medicine to be prescribed in conjunction with cognitive behavioural therapy, reinforcing that psychotherapy continues to remain central to anxiety management.
CBT helps patients identify and modify unhealthy patterns of thinking and behaviour that perpetuate anxiety. Combining medicines with structured psychological therapy often produces better long-term outcomes than either approach alone in appropriately selected patients.
The medicine will also not be available over the counter. Restricting its prescription to psychiatrists ensures that patients undergo proper evaluation before treatment is initiated and that underlying psychiatric or medical conditions are not overlooked.
Broader implications
Beyond the immediate clinical implications, the approval signals India’s expanding role in developing innovative therapies for neuropsychiatric disorders.
Leiutis Pharmaceuticals said its research pipeline is also exploring cannabinoid-based treatments for pain management and oncology using proprietary drug-delivery technologies.
Mental health experts have also emphasised on early diagnosis, greater awareness, expansion of specialist mental health services, integration of mental healthcare into primary care and reduction of social stigma to improve outcomes for millions living with anxiety disorders.
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