India · Ministry of AYUSH

AYUSH Licensing & Product Approvals

Manufacturing licences, product permissions and export certification for Ayurveda, Siddha and Unani products — handled end-to-end so your launch date does not depend on decoding the Drugs & Cosmetics Rules yourself.

Where this usually starts

  • You are launching an Ayurvedic brand and need a licensed route to manufacture — your own unit or a third party.
  • You already manufacture and want to add new products, dosage forms or a proprietary line.
  • You export (or want to) and buyers are asking for WHO-GMP certification or a Certificate of Pharmaceutical Product.
  • An application is stuck — queries, deficiencies or an inspection you are not ready for.

What we handle

AYUSH manufacturing licence

Application to your state AYUSH licensing authority for a new manufacturing unit — premises, technical staff, equipment and documentation requirements mapped before you commit capital.

Loan licence & third-party manufacturing

Launch under an existing licensed manufacturer without building a factory — agreement structure, licence application and responsibility split done correctly from day one.

Product permissions

Approvals for classical formulations (as per the authoritative texts) and proprietary Ayurvedic medicines — formulation review, rationale, safety and supporting evidence compiled per state expectations.

Schedule T GMP compliance

Gap assessment of premises, plant and quality systems against Schedule T, with a practical correction plan — not a theoretical audit report.

Export certification

WHO-GMP certification and Certificate of Pharmaceutical Product (CoPP) for export markets, plus Free Sale Certificates and document legalisation for your destination country.

Renewals, amendments & additions

Licence retention, additional-product endorsements, site or technical-staff changes and ongoing compliance so approvals never lapse mid-season.

How the engagement runs

Assess

Classify each product (classical vs proprietary), review your facility or partner options, and map the exact licences and permissions your plan needs.

Prepare

Compile the application dossier — premises documents, technical staff credentials, formulation details, labels and quality documentation.

Submit & follow up

File with the state licensing authority, coordinate the inspection, and close queries and deficiencies until approval is granted.

Launch & maintain

Post-approval support — additional products, renewals, export certificates and claim compliance as the portfolio grows.

What you receive

Regulatory pathway note — licences and permissions your specific plan requires
Complete licence and product-permission application dossiers
Schedule T gap report with a prioritised correction plan
Label and claim review against AYUSH labelling requirements
WHO-GMP / CoPP documentation and inspection preparation
Query and deficiency responses until approval

Questions founders ask us

What is the difference between classical and proprietary Ayurvedic products?

Classical formulations are made exactly as described in the authoritative Ayurvedic texts recognised under the Drugs & Cosmetics Act, and are approved on that basis. Proprietary Ayurvedic medicines are your own formulations using Ayurvedic ingredients — they need a stronger dossier covering formulation rationale, safety and supporting evidence. Most modern D2C brands fall in the proprietary category, which is why classification is the first thing we settle.

Can I launch a brand without building my own factory?

Yes. A loan licence or third-party manufacturing arrangement lets you manufacture under an existing licensed unit. It is the fastest route for a new brand — the key is structuring the agreement and applications so product permissions, label declarations and quality responsibility are correct from the start.

How long does an AYUSH manufacturing licence take?

It varies by state and by how ready your premises and documents are — typically a few months including the authority inspection. The biggest delays come from Schedule T gaps and incomplete dossiers, which is exactly what we resolve before filing rather than after a rejection.

What do I need to export Ayurvedic products?

Most regulated markets and serious buyers expect WHO-GMP certification with a Certificate of Pharmaceutical Product (CoPP), plus a Free Sale Certificate for many destinations. Requirements differ by country — we map the destination market first so you only produce the documents that are actually needed.

What claims can my Ayurvedic product make?

Claims must stay within what the product category and its approval support — and stay clear of the disease claims restricted under Indian law. For marketing teams this matters as much as the licence itself: we review packs, listings and campaigns so growth content does not put the licence at risk.

Trusted by brands we are proud to work with

From heritage Ayurveda houses to global FMCG leaders, teams rely on AIDNI to move products through regulation and into market.

Unilever
Vasu Healthcare
Pharmanza
Sitaram Ayurveda
Baidyanath
Torque
Vaidyaratnam
SKM Siddha
Nirav Healthcare
Rossari
Marico
Matxin
Soliq
Cellstar
Emami
AVS Kotakkal
Dabur
Godrej
Tabasco
Coca-Cola
Start with regulatory clarity

Planning an AYUSH licence or product approval?

Tell us your product type, current stage and target timeline. We will respond with the likely pathway, key dependencies and a recommended next step.

AIDNI Business Consultancy
Ahmedabad · Dubai · Global Network
+91 98981 AIDNI (24364) · www.aidni.me