India Pharma Outlook Team | Wednesday, 15 July 2026
Synthetic CBD Therapy has received CDSCO approval, making India the first country to clear a fully synthetic cannabidiol oral solution for anxiety disorders.
The Synthetic CBD Therapy received regulatory approval from the CDSCO for manufacturing through Leiutis Pharmaceuticals' collaboration partner, Zenara Pharma.
The therapy is meant for managing mild to moderate anxiety disorders. It will be used alongside cognitive behavioural therapy (CBT).
The approval marks a major milestone for India's pharmaceutical industry. It also positions the country at the forefront of cannabinoid-based drug innovation.
Leiutis Pharmaceuticals said the approval is the world's first for a fully synthetic cannabidiol oral solution to treat mild to moderate anxiety disorders. The company added that the product was researched, developed, patented, and clinically validated entirely in India.
The prescription-only oral solution contains 150 mg/mL of synthetic cannabidiol. It can be prescribed only by psychiatrists. The therapy is intended to complement cognitive behavioural therapy for eligible patients.
The approval is based on a successful Phase III trial conducted in India. The clinical study followed all CDSCO regulatory requirements. The companies also plan to begin a Phase IV study after the product enters the market.
The therapy combines a fully synthetic cannabidiol active pharmaceutical ingredient developed by Biophore India Pharmaceuticals with Leiutis' proprietary nanodispersible drug delivery platform.
The product will be manufactured at Zenara Pharma's facilities. These facilities comply with CDSCO, US FDA, and European Union manufacturing standards.
According to Leiutis, the therapy represents complete pharmaceutical innovation developed in India. The development covered:
The company believes this achievement showcases India's ability to deliver pharmaceutical innovation from research to commercialization.
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K. Chandrasekhar, CEO and Managing Partner of Leiutis Pharmaceuticals LLP, said, “This approval reflects nearly a decade of dedicated cannabinoid research, encompassing the development of a proprietary synthetic cannabinoid API manufacturing process, innovative drug-delivery technology, and a robust body of preclinical and clinical evidence.”
He added that the product was developed entirely in India. It is also protected by patents in key global markets. According to him, the approval strengthens the company's innovation pipeline for future cannabinoid therapies.
Dr. Jagadeesh Babu Rangisetty, Chief Executive Officer of Biophore India Pharmaceuticals, said, "We are proud that this global first was developed in India. The journey from concept to approval demanded scientific perseverance, continuous learning and close collaboration at every stage.”
The approval is expected to strengthen India's position in cannabinoid drug research. It also highlights the country's growing role in developing innovative therapies for mental health conditions.
