Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Ayurveda & Herbal Clinical Studies India | Marketed Ayurvedic Product Trials

Formulate with Confidence.

AYUSH-licensed. Dermatology-experienced. Auriga has conducted Marketed Ayurvedic Product studies for some of India's most recognised brands — under Ethics Committee approval, with dermatologist oversight, and with the scientific rigour that supports regulatory submissions and marketing claims.

Documented named-brand experience includes a Boroline Suthol Antiseptic Neem facial acne study (100 subjects, 5 sites) and an Antiseptic Neem Liquid & Gel skin conditions study (100 subjects, 5 sites) — both Marketed Ayurvedic Product (MAP) studies executed end-to-end on Auriga's clinical platform.

Auriga Research holds the Directorate of ISM&H / AYUSH licence — we were among the first herbal testing labs in India to receive it. That regulatory familiarity translates directly into clinical research credibility: protocols that anticipate AYUSH reviewer expectations, classical-and-proprietary Ayurveda study design, and analytical support that meets API and IP monograph standards.

Request a Study Proposal Call +91-7428116100

The AYUSH Credential Most CROs Cannot Match

ISM&H licensed. Named-brand Marketed Ayurvedic Product study experience. NABL + AYUSH analytical lab integration. Three signals a sponsor verifies before short-listing a CRO for AYUSH work.

ISM&H Licensed

First-Mover Status

Among the first herbal testing labs in India to receive the Directorate of ISM&H / AYUSH licence — sustained regulatory familiarity.

MAP Studies

Named-Brand Track Record

Boroline Suthol Antiseptic Neem MAP study (100 / 5 sites) and Antiseptic Neem Liquid & Gel MAP study (100 / 5 sites) — completed end-to-end.

NABL + AYUSH

Integrated Analytical Lab

Heavy metals, HPTLC, DNA fingerprinting, and API / IP identity testing under the same management — no third-party analytical hand-off.

Documented Marketed Ayurvedic Product Studies

Named-brand Marketed Ayurvedic Product (MAP) studies executed by Auriga — under Ethics Committee approval, with dermatologist supervision, and with integrated analytical support.

Dermatology — Marketed Ayurvedic Products

Study Design Subjects Sites
Boroline Suthol Antiseptic Neem — Facial Acne Marketed Ayurvedic Product Study 100 5
Antiseptic Neem Liquid & Gel — Skin Conditions Marketed Ayurvedic Product Study 100 5

Who Engages Auriga for Ayurvedic Clinical Research

Four distinct buyer profiles use Auriga's AYUSH clinical research function — each with a different evidence requirement and timeline.

AYUSH QA Heads

Generate efficacy and safety data required for AYUSH product registration and renewal — Ethics Committee–approved, dermatologist-supervised, ICMR-aligned protocols.

Brand & Marketing Teams

Substantiate "dermatologically tested" and "clinically proven" claims on marketed Ayurvedic products — accepted by AYUSH, retail buyers, and advertising standards bodies.

Formulation Scientists

Validate new herbal formulations before market launch — pilot efficacy, dermal tolerance, and dose-response studies feeding back into R&D for iterative formulation refinement.

Export-Focused AYUSH Brands

Build clinical evidence dossiers acceptable to EU, GCC, ASEAN, and African regulators — supports international AYUSH product registration and retail buyer due diligence.

Regulatory Context

Ayurvedic product studies — including Marketed Ayurvedic Product (MAP) studies — are conducted under Independent Ethics Committee approval following ICMR ethical guidelines and Ministry of AYUSH / CCRAS protocols. Full CDSCO New Drug Clinical Trial Application is not required for marketed Ayurvedic formulations or for claims substantiation studies.

Studies are accepted for AYUSH product registration and renewal, brand claim substantiation, retail buyer due diligence, and international AYUSH product registration in EU (traditional herbal medicinal products framework), GCC, ASEAN, and African markets. Where a product enters the food–drug boundary or makes a therapeutic claim equivalent to a drug indication, the CDSCO regulated pathway is required — Auriga supports both routes.

Auriga's Directorate of ISM&H / AYUSH licence for herbal testing — one of the earliest issued in India — anchors the team's regulatory familiarity. Combined with NABL and AYUSH accreditation on the analytical side, the clinical research function delivers a unified dossier that AYUSH reviewers and international retail buyers can accept with minimal back-and-forth.

Ayurvedic Study Capabilities

From Marketed Ayurvedic Product studies through classical formulation research and AYUSH evidence dossiers — every Ayurvedic CRO need on one integrated platform.

Marketed Ayurvedic Product Studies

Efficacy, safety, and tolerance studies on commercial Ayurvedic products — same model as the Boroline Suthol Antiseptic Neem and Antiseptic Neem Liquid & Gel studies Auriga has executed.

Classical Formulation Studies

Clinical studies on texts-based Ayurvedic preparations — bhasma, rasayana, single-herb and polyherbal formulations. Documentation of classical indications with modern clinical endpoints.

Proprietary Ayurveda Studies

Pilot efficacy, comparative effectiveness, and dose-response trials for patent and proprietary Ayurvedic medicines — designed per CCRAS and ICMR guidelines.

Dermal Safety & Tolerance

Patch testing, HRIPT, dermatologist-supervised tolerance evaluation, and skin compatibility studies for topical Ayurvedic products under BIS 4011:2018 and CTFA/PCPC protocols.

Heavy Metals & Standardisation Lab Support

Integrated lab support for heavy-metal profiles (lead, arsenic, mercury, cadmium), HPTLC standardisation, DNA fingerprinting, and identity verification per API and IP from our NABL- and AYUSH-accredited labs.

AYUSH Evidence Dossiers

Compilation of traditional knowledge documentation, classical references, modern clinical data, and quality testing — packaged for AYUSH licensing, registration, and international submission.

Related Services

CRO Services Overview Full CRO capabilities Cosmetics Clinical Studies Safety & claim substantiation Nutraceutical Studies FSSAI & CDSCO tracks Herbal / AYUSH Testing Heavy metals · HPTLC · Identity Accreditations NABL · ISM&H · AYUSH · USFDA Herbal / Ayurvedic Industry Hub End-to-end services

Frequently Asked Questions

What Ayurvedic study experience does Auriga have?
Auriga has executed Marketed Ayurvedic Product (MAP) studies for recognised Indian brands — including a Boroline Suthol Antiseptic Neem facial acne study (100 subjects across 5 sites) and an Antiseptic Neem Liquid & Gel skin conditions study (100 subjects across 5 sites). Both studies were conducted under Ethics Committee approval with dermatologist supervision.
Why does the ISM&H licence matter for Ayurvedic clinical research?
Auriga Research holds a Directorate of Indian System of Medicine and Homoeopathy (ISM&H) / AYUSH licence — we were among the first herbal testing labs in India to receive this licence. The licence reflects sustained AYUSH regulatory familiarity, which translates directly into clinical research credibility: protocols that anticipate AYUSH reviewer expectations, study designs aligned with classical and proprietary Ayurveda categories, and analytical support that meets the standardisation requirements of API and IP monographs.
Do Ayurvedic clinical studies need full CDSCO new drug approval?
Not generally. Ayurvedic product studies — including Marketed Ayurvedic Product studies — are conducted under Independent Ethics Committee approval following ICMR ethical guidelines and CCRAS / Ministry of AYUSH protocols. Full CDSCO New Drug Clinical Trial Application is not required for marketed Ayurvedic formulations or for claims substantiation. Studies are accepted for AYUSH product registration, marketing claims, and retail buyer dossiers.
What claims can Auriga substantiate for Ayurvedic products?
Safety claims (dermatologically tested, non-irritant, safe for topical use), efficacy claims (reduces acne, improves skin condition, soothes irritation, supports skin barrier), and performance claims aligned with the product's classical indication. Each claim is mapped to a specific study endpoint, instrument, or dermatologist grading scale during protocol design — so the resulting evidence directly supports the on-pack statement.
How is heavy-metal and standardisation testing integrated?
Ayurvedic products require parallel analytical work alongside clinical studies — heavy metals (lead, arsenic, mercury, cadmium), HPTLC standardisation, DNA fingerprinting, and identity verification per API / IP monographs. Auriga's NABL- and AYUSH-accredited analytical labs run all of this in-house. Same chain of custody from sample to clinical to final report — no third-party analytical hand-off.
Are Auriga's Ayurvedic study reports accepted for export market submissions?
Auriga's study reports are designed with international AYUSH product registration in mind — EU traditional herbal medicinal products (THMP), GCC herbal product registration, ASEAN traditional medicines framework, and African regulatory pathways. Study design and reporting incorporate ICH-aligned methodology where applicable, making the dossier portable across jurisdictions.
How long does an Ayurvedic clinical study take?
Dermal safety and tolerance studies typically run 4-8 weeks. Marketed Ayurvedic Product efficacy studies (skin, hair, GI, joint) typically run 8-16 weeks depending on disease area and endpoint. Multi-site studies (3-5 sites) add 4-6 weeks for site initiation. Detailed Gantt charts and milestone timelines are provided during proposal scoping.

Plan Your Ayurvedic Clinical Study

ISM&H-licensed. Dermatology-experienced. Marketed Ayurvedic Product study track record. NABL + AYUSH analytical lab integration. Ethics Committee approved studies.

+91-7428116100 Request a Study Proposal

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