Health and Me

Rachel V Thomas

India Approves World's First Synthetic CBD Therapy For Anxiety Disorders

India Approves World's First Synthetic CBD Therapy for Anxiety Disorders

In a global first, <span>India</span>'s drug regulator has approved a fully <span>synthetic cannabidiol</span> (CBD) therapy for the treatment of mild to moderate <span>anxiety disorders</span>, marking a significant milestone in cannabinoid-based medicine.

The Central Drugs Standard Control Organisation (<span>CDSCO</span>) has granted regulatory approval to <span>Zenara Pharma</span>, the manufacturing partner of <span>Leiutis Pharmaceuticals</span>, 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.

Also Read: <a href="https://www.healthandme.com/health-news/cyclospora-parasite-cdc-fda-trace-outbreak-in-5-states-to-taco-bell-lettuce-supplier-article-155114568" data-type="tilCustomLink" target="_blank">Cyclospora Parasite: CDC, FDA Trace Outbreak In 5 States To Taco Bell Lettuce Supplier</a>

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.

<h2>World's First Fully Synthetic <span rel="noindex">CBD Therapy</span></h2>

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.

Also Read: <a href="https://www.healthandme.com/health-news/novo-nordisks-glp-1-drug-wegovy-approved-for-fatty-liver-disease-in-india-article-155115995" data-type="tilCustomLink" target="_blank">Novo Nordisk's GLP-1 Drug Wegovy Approved for Fatty Liver Disease in India</a>

“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.

The newly approved medicine contains a fully synthetic cannabidiol (CBD) active pharmaceutical ingredient (API), meaning no cannabis plant material is used in its production.

<ul><li>A synthetic cannabidiol API developed by Biophore India Pharmaceuticals.</li><li>Leiutis Pharmaceuticals' proprietary nanodispersible drug-delivery platform to improve absorption.</li><li>Manufacturing by Zenara Pharma at facilities compliant with CDSCO, US FDA and European regulatory standards.</li></ul>

Biophore has also filed a United States Drug Master File (US DMF) for the synthetic CBD manufacturing process, reflecting internationally recognized quality standards.

Also Read:<a href="https://www.healthandme.com/health-news/botulism-cases-surge-in-uk-mhra-issues-botox-safety-warning-over-rare-life-threatening-side-effect-article-155112474" data-type="tilCustomLink" target="_blank"> Botulism Cases Surge in UK: MHRA Issues Botox Safety Warning Over Rare Life-Threatening Side Effect</a>

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 <em>The Lancet</em>, 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.

Cannabidiol (CBD) is one of the naturally occurring compounds found in hemp and cannabis plants. Unlike THC, it does not produce intoxicating effects.

CBD has been studied for several potential therapeutic uses, including:

<ul><li>Reducing anxiety symptoms</li><li>Relieving chronic pain</li><li>Improving sleep</li><li>Managing certain seizure disorders</li><li>Reducing inflammation</li></ul>

The newly approved product, however, uses synthetic CBD, which is produced entirely in a laboratory rather than extracted from the cannabis plant. Synthetic CBD offers a highly consistent and contaminant-free formulation, helping standardize dosing and quality.

<h2>Does CBD Have Proven Medical Benefits?</h2>

CBD already has established medical use in certain seizure disorders in some countries and continues to be investigated for a range of other conditions, including anxiety, chronic pain, inflammation and schizophrenia. 

CBD is generally well-tolerated, but some users may experience mild side effects like drowsiness, reduced appetite, or diarrhea. Side effects are often due to interactions with other medications.

Health Conditions A-Z

health

india-approves-worlds-first-synthetic-cbd-therapy-for-anxiety-disorders

CBD Therapy

india

Anxiety Disorders

synthetic cannabidiol

zenara pharma

leiutis pharmaceuticals

cdsco

us-woman-paralyzed-after-potassium-mistakenly-given-during-knee-replacement-surgery

US Woman Paralyzed After Potassium Mistakenly Given During Knee Replacement Surgery

moderna-and-mercks-custom-made-mrna-cancer-vaccine-shows-promise-in-late-stage-melanoma-trial

Moderna and Merck’s Custom-Made mRNA Cancer Vaccine Shows Promise In Late-Stage Melanoma Trial

ever-wonder-why-you-keep-scrolling-short-videos-your-brain-may-be-switching-off-self-control

Ever Wonder Why You Keep Scrolling Short Videos? Your Brain May Be Switching Off Self-Control

Health & Wellness

8 Sit-Up Variations to Strengthen Your Core and Build Stability

Benefits Of Ayurvedic Health Supplement Ashwagandha

9 Anti-Inflammatory Breakfast Options You Should Try

5 Foods You Should Avoid For PCOS, Says Gynecologist

Love Sitting With Your Legs Crossed? Here’s You Should Avoid It

6 Daily Foods That Are Secretly Increasing Your Calories

9 Brain Boosters You Should Do Everyday

Hip Exercises That Will Keep You Flexible As You Age

9 Leg Exercises Office Workers’ Should Do At Home

Benefits of Having Herbal Tea Every Morning

9 Daily Habits That Boost Your Brain Power

Lower-Body Exercises That Are Game-Changers

How Drinking Apple Cider Vinegar Helps You

Aging Myths You Should Never Believe

Superfoods That Support Your Gut Health

What Happens To Your Body When You Eat Instant Noodles Every Day?

Health Issues Premature Babies Often Face

Exercises Office Workers Should Do For Their Heart Health

Reasons Why You Should Add Raw Turmeric To Your Diet

Benefits Of Drinking Milk At Night: Why You Should Do It

Food That Provides Vitamin B12 Naturally In Your Diet

Surprising Health Benefits Of Fenugreek Seeds

9 Superfoods You Should Eat For Your Brain Health

What Does Mental Health Support Look Like At Work?

Long Stretches You Should Do To Unwind From Your Day

Colon Cancer In Young Adults: Early Symptoms You Should Know

Health Benefits Of Eating Dry Fruits Everyday

Are You At Risk For Fried Rice Syndrome?

These Tests Reveal How Well You Are Aging

Lower-Back Exercises You Should Do After A Long-Day's Work

Children’s Diet – What Kids Need To Eat For Immunity Building

Common Diabetes Myths That Could Hurt Your Health

Love Spicy Food? Here’s How It Affects Your Health

Superfood List: Veggies And Fruits You Must Have For Immunity

Foods People With IBS Should Avoid

Exercises To Improve Digestion

Easy Work Lunches You Can Make In The Morning

Hunger Vs Craving: Difference Explained In 60 seconds

These Things Can Cause Your Heart To Age Faster

High Carb Foods That Are Actually Healthy

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.Also Read: Cyclospora Parasite: CDC, FDA Trace Outbreak In 5 States To Taco Bell Lettuce SupplierIn 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 TherapyLeiutis 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.Also Read: Novo Nordisk's GLP-1 Drug Wegovy Approved for Fatty Liver Disease in India“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.Also Read: Botulism Cases Surge in UK: MHRA Issues Botox Safety Warning Over Rare Life-Threatening Side EffectWhy This Approval MattersThe 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.What Is CBD?Cannabidiol (CBD) is one of the naturally occurring compounds found in hemp and cannabis plants. Unlike THC, it does not produce intoxicating effects.CBD has been studied for several potential therapeutic uses, including:Reducing anxiety symptomsRelieving chronic painImproving sleepManaging certain seizure disordersReducing inflammationThe newly approved product, however, uses synthetic CBD, which is produced entirely in a laboratory rather than extracted from the cannabis plant. Synthetic CBD offers a highly consistent and contaminant-free formulation, helping standardize dosing and quality.Does CBD Have Proven Medical Benefits?CBD already has established medical use in certain seizure disorders in some countries and continues to be investigated for a range of other conditions, including anxiety, chronic pain, inflammation and schizophrenia. CBD is generally well-tolerated, but some users may experience mild side effects like drowsiness, reduced appetite, or diarrhea. Side effects are often due to interactions with other medications.

india approves world's first synthetic cbd therapy for anxiety disorders

About Us

Contact Us

Terms & Conditions

Privacy Policy

Company

Health and Me is a premium website with content written and curated to function as a handbook for all Health concerns.

India Approves World's First Synthetic CBD Therapy For Anxiety Disorders

Ever Wonder Why You Keep Scrolling Short Videos? Your Brain May Be Switching Off Self-Control

How Brachytherapy Is Personalising Radiation Therapy For Breast Cancer

Bryan Johnson Reveals Meibomian Gland Dysfunction: What To Know About This Dry Eye Condition

Health Conditions A-Z

US Woman Paralyzed After Potassium Mistakenly Given During Knee Replacement Surgery

Moderna and Merck’s Custom-Made mRNA Cancer Vaccine Shows Promise In Late-Stage Melanoma Trial

Ever Wonder Why You Keep Scrolling Short Videos? Your Brain May Be Switching Off Self-Control