India Approves World’s First Synthetic CBD Oral Solution for Anxiety Treatment
India approves world’s first synthetic CBD oral solution for anxiety treatmentThis approval, which is limited to psychiatrists, is based on a successful Phase III clinical trial conducted in India in accordance with CDSCO requirements and will be followed by a Phase IV study.
Last Updated 15 July 2026, 14:49 IST
A representational image of a hemp plant
Regulatory Milestone and Clinical Evidence
The Central Drugs Standard Control Organisation (CDSCO) has granted Leiutis Pharmaceuticals approval for its synthetic cannabidiol (CBD) oral solution, formulated at 150 mg/mL, to treat mild‑to‑moderate anxiety disorders. This marks the first global approval of a fully synthetic oral CBD product.
Development Collaboration and Technology
The product combines a synthetic CBD active pharmaceutical ingredient (API) created by Biophore India Pharmaceuticals with Leiutis’ proprietary nanodispersible drug‑delivery platform. Manufacturing occurs at Zenara Pharma’s facilities, which hold CDSCO, FDA, and EU compliance certifications.
Safety Profile and WHO Perspective
According to the World Health Organisation, CBD shows no signs of abuse or dependence potential in humans. The WHO’s critical review further notes that there is currently no evidence linking pure CBD to recreational use or public‑health harms.
Legal Context in India
Under India’s Narcotic Drugs and Psychotropic Substances (NDPS) Act, cannabis flowers and resin remain classified as narcotics. However, extracts derived from hemp leaves and seeds containing less than 0.3 % THC are permissible for therapeutic use, a framework that supported the regulatory pathway for this synthetic CBD formulation.
Next Steps and Global Outlook
Leiutis indicates that the approval will be followed by a Phase IV post‑marketing study to gather long‑term safety and effectiveness data. The company has also filed a United States Drug Master File (US DMF) for the synthetic CBD API, signalling alignment with international quality standards.
Statement from Leadership
K. Chandrasekhar, CEO and Managing Partner of Leiutis Pharmaceuticals LLP, remarked that the approval reflects nearly a decade of cannabinoid research, encompassing API synthesis, drug‑delivery innovation, and a robust preclinical and clinical evidence base. He thanked the Government of India, clinical investigators, researchers, and study participants for their contributions.
For the original announcement, see the source: Here
