Health & Me India write
In a global first, India’s drug regulator has approved a fully synthetic cannabidiol (CBD) therapy for the treatment of mild to moderate anxiety disorders, marking a significant milestone in cannabinoid-based medicine.
The Central Drugs Standard Control Organisation (CDSCO) has granted regulatory approval to Zenara Pharma, the manufacturing partner of Leiutis Pharmaceuticals, to produce a synthetic cannabidiol oral solution (150 mg/ml). The prescription-only therapy is intended to be used alongside cognitive behavioural therapy (CBT) for managing mild to moderate anxiety disorders.
In a statement, Leiutis Pharmaceuticals said the approval follows a successful Phase III clinical trial conducted in India under CDSCO guidelines. A Phase IV post-marketing study will now be carried out to further evaluate the therapy.
World’s First Fully Synthetic CBD Therapy
Leiutis noted that “this is the first regulatory approval anywhere in the world for a fully synthetic cannabidiol oral solution for anxiety disorders”.
K. Chandrasekhar, CEO and Managing Partner of Leiutis Pharmaceuticals LLP, said the approval is the result of nearly a decade of cannabinoid research, including the development of a proprietary synthetic cannabinoid manufacturing process, novel drug-delivery technology, and extensive preclinical and clinical studies.
“Developed entirely in India and protected by patents in key markets, this approval is a significant milestone for our innovation pipeline, paving the way for next-generation cannabinoids. We thank the Government of India, clinical investigators, researchers and study participants who made it possible,” Chandrasekhar said.
What Is the New CBD Therapy?
The newly approved medicine contains a fully synthetic cannabidiol (CBD) active pharmaceutical ingredient (API), meaning no cannabis plant material is used in its production.
The therapy combines:
- A synthetic cannabidiol API developed by Biophore India Pharmaceuticals.
- Leiutis Pharmaceuticals’ proprietary nanodispersible drug-delivery platform to improve absorption.
- Manufacturing by Zenara Pharma at facilities compliant with CDSCO, US FDA and European regulatory standards.
Biophore has also filed a United States Drug Master File (US DMF) for the synthetic CBD manufacturing process, reflecting internationally recognized quality standards.
Why This Approval Matters
The approval comes at a time when anxiety disorders are rising sharply in India. According to a recent analysis from the Global Burden of Disease Study published in The Lancet, anxiety disorders in India increased by 123.5% between 1990 and 2023.
The prevalence rose from 2,591.9 cases per lakh population in 1990 to 5,792.8 cases per lakh in 2023, driven largely by increasing rates of anxiety and depression.
