AYUSH Manufacturing Licence (Form 25-D): Process, Documents and Realistic Timeline

Who Needs This Licence and Who Does Not

A manufacturing licence for Ayurvedic, Siddha and Unani medicines is required by the facility that actually manufactures the products. It is issued by the State Licensing Authority, typically operating through the state AYUSH or Drug Control department, under the Drugs and Cosmetics Act and the rules made under it.

If you are a brand owner planning to have products made by an existing licensed unit, you do not need your own manufacturing licence. You rely on their licence, and your job is to verify it covers your dosage form and your products. A loan licence route also exists where you manufacture in someone else premises under your own arrangement, with its own application pathway and requiring consent from the licensed unit.

So the first decision is not how to apply, but whether you need to. Setting up a unit is justified by volume and control, not by status.

What Must Be Ready Before You Apply

Applications stall because the underlying requirements were not in place when the file was submitted. Three things must genuinely exist first.

Premises meeting Schedule T good manufacturing practice requirements, with separate areas for raw material storage, quarantine, manufacturing, packing, quality control and support functions, built with cleanable finishes and sensible material and personnel flows.

A qualified technical person, whose qualification must be relevant to Ayurveda as specified in the applicable rules, appointed with their consent and documentation on file. And manufacturing plus testing capability appropriate to your dosage forms, either an in-house quality control laboratory or a documented arrangement with an approved outside laboratory.

Documents to Assemble

Incomplete documentation is the single most common reason for a deficiency letter. Prepare these before filing.

Give particular thought to the product list. Your licence is endorsed for specific dosage forms and products, so a list drawn up carelessly limits what you can legally make later and forces an amendment application.

How the Process Runs, Step by Step

The sequence is consistent even though details vary by state.

1. Prepare the premises to Schedule T requirements, including separated areas and appropriate finishes.
2. Appoint the qualified technical person and complete their documentation.
3. Install machinery suited to your dosage forms and arrange quality control testing capability.
4. Finalise the product list with formulations and dosage forms.
5. File the application in Form 24-D with all documents and the prescribed fee.
6. Respond promptly and completely to any deficiency or query letter issued after scrutiny.
7. Host the inspection by the Drug Inspector or nominated officer, who will examine premises, equipment, storage, hygiene, personnel and records.
8. Address any inspection observations in writing with evidence.
9. Receive the licence in Form 25-D, endorsed for the approved products and dosage forms.

Realistic Timelines and Where the Time Goes

There is no single national timeline, and anyone quoting a fixed number of days is describing their own experience in one state rather than a rule. Practically, where premises are genuinely ready, documents are complete and the inspection raises no major observation, the process runs from several weeks to a few months.

Understanding where time is consumed is more useful than a headline figure. The largest block is almost always preparing the premises, which happens before the application. The second is document scrutiny and the deficiency cycle, which is entirely within your control. The third is inspection scheduling, which is not.

The single most effective accelerator is avoiding a deficiency cycle. A complete, well-organised file with a correctly drawn product list can save weeks that no amount of follow-up will recover afterwards.

Costs to Plan For

Application fees are rarely the significant cost. The real investment is in the premises: rent or construction, bringing finishes and layout to Schedule T expectations, machinery for each dosage form, quality control laboratory equipment or testing arrangements, and the technical person salary.

Then add working capital for raw material, packaging and the first production runs, plus professional fees if you use a consultant. If you opt for loan licensing or third party manufacturing instead, most of these disappear and are replaced by a per unit manufacturing charge, which is why that route dominates early-stage brands.

Common Mistakes and How to Avoid Them

Each is followed by the preventive step.

1. Applying before the premises are ready. Inspection examines the actual facility; apply when it is genuinely complete.
2. A carelessly drawn product list. Think through your two-year range before finalising, since endorsements follow the list.
3. Planning too many dosage forms at once. Each form needs its own separated section, adding area, cost and complexity.
4. Weak or late deficiency replies. Reply completely and quickly; this is the controllable part of the timeline.
5. No testing arrangement. Have either an in-house laboratory or a documented approved outside laboratory arrangement.
6. Ignoring material and personnel flow. Flows that cross draw observations even when the area is adequate.
7. Assuming another state requirements apply. Confirm with your own State Licensing Authority.
8. Building a unit before proving demand. Consider third party manufacturing until volume justifies a facility.

Pre-Application Checklist

Complete every line before filing.

1. Route decided: own unit, loan licence or third party manufacturing.
2. Current state requirements confirmed with the licensing authority.
3. Premises built to Schedule T with separated areas and cleanable finishes.
4. Material and personnel flows designed without crossing.
5. Qualified technical person appointed with documentation complete.
6. Machinery installed for each intended dosage form.
7. Quality control laboratory or approved outside arrangement in place.
8. Product list finalised with formulations and dosage forms.
9. Full document set assembled and checked against the authority list.
10. Application in Form 24-D filed with the prescribed fee.

Frequently Asked Questions