Leiutis Pharmaceuticals LLP has announced that the Central Drugs Standard Control Organisation (CDSCO) has granted government support to its collaboration partner, Zenara Pharma, to produce a Synthetic Cannabidiol Oral Solution 150 mg/mL for the management of mild to moderate anxiety disorders, to be applied alongside cognitive behavioural therapy (CBT).
The prescription-only treatment, which is arranged exclusively by psychiatrists, is based on a fruitful Phase III clinical trial conducted in India in agreement with CDSCO requirements. The organization plans to undertake a Phase IV study following the approval.
According to Leiutis, the approval marks the worldwide first regulatory approval of a completely synthetic cannabidiol oral service for managing mild to moderate anxiety disorders. The product has been researched, developed, patented, and clinically validated in India.
The therapy combines a fully synthetic cannabidiol (CBD) active pharmaceutical ingredient (API) developed by Biophore India Pharmaceuticals with Leiutis' proprietary nanodispersible drug delivery platform, and will be manufactured at Zenara Pharma's CDSCO-, US FDA-, and EU-compliant manufacturing facilities.
The organization's product shows end-to-end healthcare innovation developed in India, encompassing API advancement, drug delivery procedures, healthcare research, and regulatory approval.
Commenting on the milestone, 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. 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."
According to Towards Healthcare, the cannabidiol market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 12.03 billion in 2026 to approximately USD 45.17 billion by 2035, representing a compound annual growth rate (CAGR) of 15.83% from 2026 to 2035, driven by cannabidiol has increasing attention regarding its application in cutaneous pathologies like atopic dermatitis, psoriasis, acne, epidermolysis bullosa, systemic sclerosis, seborrheic dermatitis, androgenetic alopecia and cutaneous melanoma, though its bioactivities still lack scientific proof and some of its mechanisms of action continue to be explained. CBD serves as a novel therapeutic approach for the management of OUD, not only for withdrawal symptom relief, partly because of its anxiolytic characteristics, but also to lessen the craving and prevent relapse. CBD acts as an antioxidant and anti-inflammatory agent. It is gradually used in preparations targeting dermatological conditions like acne and eczema.
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. This approval reinforces India's capability to deliver worldwide relevant pharmaceutical innovation from discovery through commercialisation," he said.
CDSCO is responsible for the approval of drugs, conduct of clinical trials, laying down the standards for therapeutics, control over the quality of significant medicines in the country, and coordination of the activities of state drug control organizations by offering expert advice with a view to bringing about uniformity in the enforcement of the Drugs and Cosmetics Act. The CDSCO safeguards drug safety in India by adaptable approvals, monitoring quality, and maintaining standards for healthcare products. CDSCO is a licensing authority, a government agency that approves any novel chemical entity (drug) that is to be significant to India. Managing with State Drug Control Organizations to confirm uniformity in how regulations and the Drugs and Cosmetics Act are enforced in the country. Providing expert technology advice and granting central licenses for producing particular categories of healthcare tools and therapeutics.
A recent report by Towards Healthcare highlights that the cannabidiol market is witnessing growth because it has the potential efficiency of CBD in lowering chronic pain, which is also considered in lessening the symptoms of different brain disorders like epilepsy, Alzheimer's, Huntington's, and Parkinson's disease. Application of CBD to manage psychiatric conditions like psychosis, anxiety and fear, depression, and substance use disorders is explored. CBD supports reducing pain by hindering pain receptors, lessening inflammation, and increasing the body's own natural pain relievers. Numerous CBD oils provide benefits ranging from anti-inflammation, lessening pain, lowering stress and anxiety, improving sleep quality, and overall enhanced quality of life, making CBD oil a standard option for the management of chronic diseases.
