CDSCO clears India-developed prescription treatment for mild to moderate anxiety; therapy to be used along with cognitive behavioural therapy.

India has approved what is being described as the world's first fully synthetic cannabidiol (CBD) oral solution for the treatment of mild to moderate anxiety disorders, marking a major milestone in home-grown pharmaceutical innovation.

Leiutis Pharmaceuticals announced on Tuesday that the Central Drugs Standard Control Organisation (CDSCO) has granted regulatory approval to its collaboration partner, Zenara Pharma, to manufacture the Synthetic Cannabidiol Oral Solution 150 mg/mL. The medicine will be available only on prescription by psychiatrists and is intended to be used alongside cognitive behavioural therapy (CBT).

The approval follows the successful completion of a Phase III clinical trial conducted in India under CDSCO guidelines. A Phase IV study will now be carried out to further monitor the medicine's safety and effectiveness after its launch.

Calling the approval a landmark achievement, K. Chandrasekhar, CEO and Managing Partner of Leiutis Pharmaceuticals, said the product is the result of nearly a decade of research on cannabinoid-based medicines. He said the therapy was researched, developed, patented and clinically validated entirely in India and reflects the country's growing strength in pharmaceutical innovation.

The company said the new therapy combines a fully synthetic cannabidiol active pharmaceutical ingredient (API), developed by Biophore India Pharmaceuticals, with Leiutis' proprietary nanodispersible drug delivery technology. Manufacturing will take place at Zenara Pharma's CDSCO-, US FDA- and EU-compliant facilities.

According to the company, the product contains no cannabis plant material. It uses a fully synthetic form of cannabidiol, which is considered non-psychoactive and is not associated with abuse or dependence, making it different from psychoactive cannabis-derived products.

Dr. Jagadeesh Babu Rangisetty, Chief Executive Officer of Biophore India Pharmaceuticals, said the approval highlights India's ability to deliver globally relevant pharmaceutical innovation from scientific discovery to commercialisation. He added that the journey required years of scientific research, collaboration and perseverance.

The approval comes at a time when anxiety disorders continue to be a major mental health concern in India. According to the National Mental Health Survey 2015-16 conducted by NIMHANS, anxiety disorders affect a significant number of adults, while treatment gaps for mental health conditions remain high. Experts believe improved access to effective therapies is essential for better patient care.

Welcoming the approval, Dr. Sanjay Sharma, President – Corporate Strategy & Growth at Leiutis Pharmaceuticals, said the company is committed to making the new treatment available across India through psychiatrists and strengthening access to innovative mental healthcare solutions.

The approval also expands Leiutis Pharmaceuticals' innovation pipeline, which focuses on neuropsychiatry, pain management and oncology, while positioning India at the forefront of synthetic cannabinoid drug development.