Loan License in India: Drug, Cosmetic and Medical Device Loan Licence Guide
Loan license in India for pharma, cosmetic and device brands: Form 25A & 28A, COS-9, MD-6 & MD-10 filing with a host unit. Free consultation.
- Fast-track application drafting & authority liaisoning
- Guaranteed compliance with CDSCO/FSSAI/State guidelines
- 100% turnkey documentation support from start to approval
Connect with our senior regulatory experts in 15 mins.
What Is a Loan License? Loan Licence Meaning in Simple Words
A loan license is a manufacturing licence granted to a company that does not own a factory but wants to make products under its own name using the factory of an already licensed manufacturer. The company that holds the loan licence is the loan licensee; the company that owns the factory is the host manufacturer, sometimes called the principal licensee. The loan licensee owns the brand, decides the formula and markets the product; the host provides the plant, machinery, testing laboratory and technical staff. The licence is called a loan licence because the manufacturing facility is, in effect, loaned to the brand owner for its products.
The Drugs Rules, 1945 put it precisely. Rule 69A describes a loan licence as one the licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to use the manufacturing facilities owned by a licensee who already holds a manufacturing licence. Before granting it, the authority must be satisfied that the host unit has adequate equipment, staff, capacity and testing facilities to manufacture on behalf of the applicant. The same idea is used for cosmetics under the Cosmetics Rules, 2020 and for medical devices under the Medical Devices Rules, 2017.
So the loan license meaning is simple: your brand, your licence, someone else's factory. In India, a loan licence for drugs is granted by the State Drug Licensing Authority when the host unit is located in the same state; when your host is in another state, the licence comes from that state's licensing authority, because a loan licence always follows the factory, not the brand owner's office.
Loan licence at a glance
| Point | Drugs | Cosmetics | Medical devices |
|---|---|---|---|
| Rules | Drugs Rules, 1945 (Rules 69A and 75A) | Cosmetics Rules, 2020 | Medical Devices Rules, 2017 |
| Application form | Form 24A or Form 27A | COS-6 | MD-4 (Class A, B) or MD-8 (Class C, D) |
| Loan licence form | Form 25A or Form 28A | COS-9 | MD-6 or MD-10 |
| Granted by | State Licensing Authority of the host's state | State Licensing Authority of the host's state | State authority for Class A and B; CDSCO for Class C and D |
| Government fee | ₹6,000 per application up to 10 items per category, plus ₹1,500 inspection fee | ₹10,000 per 10 items per category | ₹5,000 per site + ₹500 per device (A, B); ₹50,000 per site + ₹1,000 per device (C, D) |
| Validity | Perpetual, with a retention fee every 5 years | Perpetual, with a retention fee every 5 years | Perpetual, with a retention fee every 5 years |
Loan License in Pharma: How It Works for Drug Brands
The loan license in pharma is the classic route for marketing companies that want their own manufacturing identity. Thousands of Indian pharma brands, especially in tablets, capsules, syrups, ointments and nutraceutical-style drug products, are made in host plants in Himachal Pradesh, Uttarakhand, Gujarat, Uttar Pradesh and elsewhere under a pharma loan license. The brand owner holds the drug loan license; the host runs the production line for the brand owner's batches alongside its own.
In practice, a loan license in pharma works like this. The brand owner signs an agreement with a host that already holds a manufacturing licence on Form 25 or Form 28 and complies with the revised Schedule M good manufacturing practices. The brand owner then applies to the State Licensing Authority on Form 24A (for drugs other than those in Schedules C, C(1) and X) or Form 27A (for Schedule C and C(1) drugs), listing the products it wants to make at that host. After scrutiny and, usually, an inspection of the host unit, the authority grants the loan licence on Form 25A or Form 28A, with the approved product list attached.
The host manufacturer and the loan licensee
The host supplies the premises, equipment, production staff and, usually, the quality control laboratory. The loan licensee supplies the brand, the product specifications and often the raw and packing materials, and it pays the host for conversion. Both names matter on the label: the product is manufactured at the host's address, under the loan licence number granted to the brand owner. Buyers, distributors and tender committees read these details, so a clean loan licence adds credibility to a young pharma brand.
Who carries responsibility for quality
A loan licence does not let the brand owner hand all responsibility to the host. The loan licensee is a manufacturer in the eyes of the law and answers for the quality of every batch sold under its licence, together with the host. If a batch is declared not of standard quality, the regulator can act against both. That is why serious brand owners appoint their own quality person, approve the host's batch records, keep reference samples and audit the host regularly, instead of treating the loan licence as a formality.
Types of Loan Licence in India: Drugs, Cosmetics and Medical Devices
There is no single all-purpose loan licence. The form, the fee and the authority depend on what you want to manufacture. Choose the wrong one and the application is returned, so the first step is always to classify your products correctly.
Drug loan license: Form 25A and Form 28A
A drug loan license is granted under the Drugs Rules, 1945 in one of two forms. The form 25A loan license (applied for on Form 24A, under Rule 69A) covers drugs other than those in Schedules C, C(1) and X: most tablets, capsules, oral liquids, ointments, creams and powders. The form 28A loan license (applied for on Form 27A, under Rule 75A) covers drugs in Schedules C and C(1), such as injectables, sera and certain biological and sterile products. For some Schedule C and C(1) products, such as vaccines, blood products and large volume parenterals, the state licence also needs approval from the central licence approving authority, so these files take longer. A product that is still a new drug needs CDSCO permission before any state can grant a loan licence for it.
The host must hold the matching manufacturing licence: Form 25 for a Form 25A loan licence and Form 28 for a Form 28A loan licence, with the same dosage forms and categories on its own licence. A host licensed only for tablets cannot make your syrup under a loan licence, however willing it is.
Cosmetic loan license: COS-6 and COS-9
A cosmetic loan license lets a brand owner manufacture creams, lotions, shampoos, hair oils, soaps, lipsticks and other cosmetics at a licensed cosmetic manufacturer's unit. The application is made on Form COS-6 through CDSCO's online portal (SUGAM) to the State Licensing Authority of the host's state, and the licence is granted on Form COS-9. The fee is ₹10,000 for up to 10 items in each category, with ₹500 for each additional item, and the rules set a 45-day decision period. The old forms, 31-A and 32-A, no longer apply. Read the full process on our Cosmetic Loan License page.
Medical device loan license: MD-4, MD-6, MD-8 and MD-10
A medical device loan license follows the device's risk class. For Class A and Class B devices, the application is made on Form MD-4 to the State Licensing Authority and the licence is granted on Form MD-6. For Class C and Class D devices, the application is made on Form MD-8 to the Central Licensing Authority (CDSCO) and the licence is granted on Form MD-10. Both are filed on CDSCO's online system for medical devices, and the host must already be licensed for the same device category. Read the full process on our Medical Device Loan License page.
Loan License vs Own Manufacturing License vs Third-Party Manufacturing
Brand owners usually compare three routes. The right one depends on your budget, your timeline and how much control you want over the product and the licence.
| Point | Own manufacturing licence | Loan licence | Third-party manufacturing |
|---|---|---|---|
| Who owns the factory | You | The host | The manufacturer |
| Whose licence covers the product | Yours | Yours, at the host's address | The manufacturer's |
| Capital needed | High: land, building, machinery, laboratory | Low: agreement, materials, staff for quality oversight | Lowest: purchase order only |
| Time to market | 12–24 months or more | Typically 2–4 months | Fastest, once the manufacturer agrees |
| Control over formula and quality | Full | High, through the agreement and your own quality person | Limited to the manufacturer's existing products or terms |
| Name shown as manufacturer | You | Host's site, under your loan licence | The manufacturer; you appear as marketer |
| Moving to another factory | Not applicable | New loan licence needed for the new host | Change of supplier only |
Loan license vs third party manufacturing
The loan license vs third party manufacturing choice is the one most pharma marketing companies face. In third-party manufacturing, the product is made under the manufacturer's own licence and your company appears on the label only as the marketer. It is quick and needs no licence of your own beyond a sale licence, but you depend on the manufacturer's product list and pricing, and under the rules a marketer still shares responsibility for the quality of what it sells. With a loan licence, the product is licensed in your company's name, you control the formula and specifications, and the product history stays with your company even if you later move to a different host. Many brands start with third-party supply for a few products and move their core range to a loan licence once volumes grow.
When to move from a loan licence to your own plant
A loan licence is not meant to be permanent for every brand. When your volumes fill several days of the host's capacity every month, when you need dedicated lines (for example for hormones, cephalosporins or sterile products), or when tenders demand a manufacturer with its own facility, it is time to plan your own drug manufacturing license. Regovex helps you plan that transition so your existing loan licence products keep selling while the new plant is approved.
Who Should Choose a Loan Licence?
A loan licence suits businesses that want product ownership without a factory:
- Pharma marketing companies that want a drug loan license in their own name instead of buying finished goods from third parties
- Start-up cosmetic and personal care brands testing products before investing in a plant
- Medical device brands importing components or designs and getting the device made at a licensed Indian site
- Exporters who need a manufacturing licence in their own name for export registrations and certificates
- Existing manufacturers who want to make a product their own plant is not licensed for, at a host that is
- Hospital chains and distributors launching private-label products
A loan licence is not the right fit if you only want to resell another company's product unchanged, or if your product needs a dedicated facility that no host can share. In those cases, a sale licence or your own manufacturing licence is the better route.
Eligibility for a Loan License in India
To qualify for a drug loan license, a cosmetic loan licence or a medical device loan licence, you need four things in place before you file:
- A legal entity. A proprietorship, partnership, LLP or company with a registered office, PAN and, usually, GST registration. The loan licence is issued in the entity's name, so the name must match on every document.
- A licensed host. A manufacturer holding a valid manufacturing licence for the same product category and dosage form, with spare capacity and a good inspection record. For drugs, the host must comply with the revised Schedule M; for devices, with the quality management system in the Fifth Schedule of the Medical Devices Rules.
- A written agreement and consent. The host's consent letter and a manufacturing agreement setting out who supplies materials, who tests, who releases batches and who keeps records.
- Products the host can make. A product list with formulations, specifications and labels, where every product falls within the host's licensed categories and, for drugs, is not a new drug without CDSCO permission.
You do not need your own factory, machinery or laboratory. You do need to show the licensing authority that the host has the equipment, staff, capacity and testing facilities to make your products, which is why the host's documents carry as much weight as yours.
Loan License Documents Required
The loan license documents fall into four groups. Exact formats differ by product type and state, so treat this as the master list.
Applicant documents
- Constitution proof: certificate of incorporation, partnership deed, LLP agreement or proprietor's declaration
- PAN, GST registration and proof of the registered office
- Identity and address proof of directors, partners or the proprietor
- Affidavit of non-conviction under the Drugs and Cosmetics Act
- Authorisation letter or board resolution for the signatory
Host manufacturer documents
- Copy of the host's valid manufacturing licence with its approved product categories
- Host's consent letter and the signed manufacturing (loan licence) agreement
- Site plan, layout and list of equipment for the relevant section
- List of the host's technical staff with qualifications and approval letters
- Recent GMP certificate or inspection report, where available
Product documents
- Product list with composition, strength and dosage form for each item
- Specifications and methods of analysis for each product
- Label and carton drafts showing the loan licence details correctly
- Stability or test data where the authority asks for it
- Undertaking that the proposed brand names are not the same as or similar to existing brand names
Fee and declarations
- Government fee challan or online payment receipt
- Declarations required by the form you are using (Form 24A, Form 27A, COS-6, MD-4 or MD-8)
The most common reasons for returns are a host licence that does not cover the dosage form, an agreement signed by someone without authority, brand names that clash with existing products, and labels that show the wrong licence number.
Loan License Process in India: Step by Step
The loan license process is broadly the same for all three product types; the forms and portals differ.
- Classify your products. Decide whether each product is a drug, a cosmetic or a medical device, and for drugs whether it falls in Schedule C or C(1); for devices, confirm the risk class.
- Shortlist and audit hosts. Check each host's licence, capacity, inspection history and quality systems before you sign.
- Sign the agreement. Fix responsibilities for materials, testing, batch release, records, recalls and confidentiality.
- Prepare the dossier. Product list, specifications, labels and all applicant and host documents.
- File the application. Drug loan licences are filed on ONDLS or your state drug licensing portal with the State Drug Licensing Authority where your host is in India; cosmetic loan licences are filed on SUGAM; device loan licences on CDSCO's online system for medical devices.
- Pay the government fee online and upload the receipt.
- Scrutiny and inspection. The authority checks the file and usually inspects the host unit for the products you have applied for. Answer queries quickly and completely.
- Grant. The loan licence is issued on Form 25A, Form 28A, COS-9, MD-6 or MD-10, with the approved product list. Production of your batches can begin under it.
How long does a loan licence take?
For a clean drug loan licence application with a well-run host, approval typically takes 45 to 90 days, depending on the state's inspection schedule. The Cosmetics Rules set a 45-day decision period for COS-9, and the Medical Devices Rules set fixed timelines for MD-6 and MD-10. Most delays come from host-side gaps and queries that are answered late, both of which can be prevented before filing.
A typical drug loan licence timeline
| Week | What happens |
|---|---|
| 1–2 | Product classification, host shortlist and host due diligence |
| 2–3 | Agreement signed; product list, specifications and labels finalised |
| 3–4 | Dossier checked and the application filed with the fee |
| 4–8 | Scrutiny, queries and inspection of the host unit |
| 6–12 | Grant of the Form 25A or Form 28A loan licence and the first batch |
The weeks overlap because good preparation lets several steps run together. The biggest saving comes from auditing the host before you sign, so the inspection finds nothing new.
Loan License Fees: Drugs, Cosmetics and Medical Devices
Government loan license fees are set by the rules and are the same in every state. Professional fees are separate.
| Loan licence | Government fee | Additional items | Inspection fee |
|---|---|---|---|
| Form 25A loan license (on Form 24A) | ₹6,000 for up to 10 items in each category | ₹300 per additional item | ₹1,500 per inspection |
| Form 28A loan license (on Form 27A) | ₹6,000 for up to 10 items in each category | ₹300 per additional item | ₹1,500 per inspection |
| Cosmetic loan licence COS-9 (on COS-6) | ₹10,000 for up to 10 items in each category | ₹500 per additional item | See the child page |
| Medical device loan licence MD-6 (on MD-4) | ₹5,000 per site | ₹500 per distinct device | Audit costs, where applicable, are separate |
| Medical device loan licence MD-10 (on MD-8) | ₹50,000 per site | ₹1,000 per distinct device | Inspection by CDSCO where required |
Worked example
A pharma brand wants 14 tablet and capsule products at one host under a form 25A loan license. The government fee is ₹6,000 for the first 10 items, plus 4 × ₹300 = ₹1,200 for the extra items, plus ₹1,500 for the inspection: ₹8,700 in total. If the same brand also wants three injectables at another host, that is a separate form 28A loan license application with its own fee. Confirm the current amounts on the portal on the day you apply.
Loan Licence Validity, Retention Fee and Changes
A loan licence no longer needs renewal in the old sense. A drug loan licence on Form 25A or Form 28A remains valid as long as the retention fee, equal to the licence fee, is paid before the end of every five-year period from the date of issue. If you pay late, a late fee of 2% of the licence fee per month applies for up to six months; after that, the loan licence is treated as cancelled and you must apply afresh. Cosmetic loan licences under the Cosmetics Rules, 2020 and medical device loan licences under the Medical Devices Rules, 2017 follow the same perpetual-with-retention model.
During the life of the loan licence, apply or inform the authority before you:
- Add new products, strengths or dosage forms
- Change the brand name of an approved product
- Change the constitution, ownership or registered office of your company
- Move production to a different host, which needs a new loan licence at that host
- Change the label in a way that affects licence details
Choosing a Host Manufacturer: Due-Diligence Checklist
Your loan licence is only as strong as your host. Before you sign, check:
- Licence scope. The host's manufacturing licence must cover your exact dosage forms and categories.
- Compliance record. Ask for recent inspection reports, any show-cause notices and the host's not-of-standard-quality history.
- Capacity. Confirm the host can fit your batch sizes without delaying them behind its own products.
- Quality control. Check whether the host's laboratory can test your products, or whether an approved outside laboratory will be used.
- Documentation. Look at a sample batch manufacturing record and the host's change-control and deviation systems.
- Other loan licensees. A host making products for many brands should show how it prevents mix-ups between them.
- Financial stability. A host that closes or loses its licence takes your production down with it.
What the loan licence agreement should cover
A good agreement sets out who buys and approves raw and packing materials, who tests and releases batches, how batch records and reference samples are kept and shared, how complaints and recalls are handled, what happens on an adverse inspection, the notice period for exit, confidentiality of your formulas, and the pricing for conversion. Regovex reviews the regulatory clauses so that the agreement matches what the licensing authority expects to see.
After Approval: Compliance for Loan Licensees
Once the loan licence is granted, the work shifts to keeping it clean:
- Batch records. Keep copies of every batch manufacturing and testing record for your products, not only the host's summary.
- Testing and release. Make sure each batch is tested against the approved specifications before release, and keep the certificates of analysis.
- Labelling. Show the manufacturing site address and your loan licence number correctly on every label and carton.
- Reference samples. Keep retained samples of each batch for the period the rules require.
- Complaints and recalls. Record and investigate every complaint, and have a recall procedure that both you and the host follow.
- Retention fee. Track the five-year retention date for each loan licence.
If the host's licence is suspended or cancelled
Your loan licence depends on the host's manufacturing licence. For cosmetics, the rules state plainly that a COS-9 loan licence is cancelled along with the host's licence. For drugs and devices the effect is the same in practice: production at that host must stop until the host's licence is restored, or you obtain a new loan licence at another host. Keeping a second qualified host in mind for your core products is the simplest protection.
Labelling under a loan licence
Labels are where loan licence mistakes become visible to every buyer and inspector. Under a pharma loan license, the label must show the manufacturing site, which is the host's address, and the manufacturing licence number, which is your loan licence number, not the host's own licence number. Batch number, manufacturing and expiry dates, and the other particulars required by the labelling rules follow as usual. Cosmetic and device labels have their own requirements under their rules. Regovex checks your artwork against the granted loan licence before the first print run, because reprinting cartons after a query is the most avoidable cost in a new launch.
Common Mistakes in Loan Licence Applications
- Applying in the brand owner's state when the host is in another state
- Choosing a host whose licence does not cover the dosage form or category
- Filing a Form 24A for products that belong in Schedule C or C(1)
- Brand names that are the same as or similar to existing brands
- Labels drafted before the licence number is known, with placeholder errors left in
- No agreement, or an agreement silent on testing and batch release
- Missing the retention fee date and losing the loan licence
Loan Licences for Exporters, Start-ups and Marketplace Sellers
Exporters often need a manufacturing licence in their own name to register products abroad or to obtain export certificates, and a loan licence can provide that without a factory. Start-ups can launch a small range under a loan licence and add products as sales grow. Marketplace sellers on online platforms are increasingly asked to show the manufacturer's licence for every listing; a loan licence in your own company's name makes those checks simpler than relying on a third party's documents. In each case, the key is matching the product range to the right host and the right form from the start.
How Regovex Handles Your Loan License in India
- Free eligibility check. We classify your products and confirm whether a drug, cosmetic or medical device loan licence, or a different route, fits your plan.
- Host due diligence. We review your shortlisted hosts' licences, scope and compliance record, or suggest hosts where you have none.
- Agreement review. We check the regulatory clauses of your loan licence agreement.
- Dossier preparation. Applicant, host and product documents, labels and declarations, checked against the form you are filing.
- Online filing on ONDLS or your state drug licensing portal, SUGAM or CDSCO's online system for medical devices, as applicable.
- Query replies within 24–48 hours and support during the host inspection.
- Grant and handover. We check the licence and product list, then set up your batch-record, labelling and retention-date tracking.
Why Brands in India Choose Regovex for Their Loan Licence
- All three loan licences under one roof. Drug loan licences on Form 25A and 28A, cosmetic loan licences on COS-9, and medical device loan licences on MD-6 and MD-10.
- Host-side experience. As a drug license consultant that also files manufacturing licences, we know what a licensing authority checks at the host unit.
- CDSCO and state FDA approval experience, including CDSCO registration consultant work for devices, imports and cosmetics.
- Clear pricing, with government and professional fees shown separately in writing.
- 99.8% approval rate across 100+ clients, rated 4.9/5 in verified client feedback.
- One point of contact from the first call to the licence and the five-year retention reminders.
Loan License Services in India and Nearby Areas
Regovex files loan licence applications for pharma marketing companies, cosmetic brands and medical device companies in India. Documents are collected digitally, and we coordinate directly with your host manufacturer, wherever it is located. Our office is in Aligarh, and we work with clients across Delhi NCR, Uttar Pradesh and the rest of India.
We also serve brands in .
Related services:
- Cosmetic Loan License in India
- Medical Device Loan License in India
- Drug Manufacturing License in India
- Drug Test License, for developing new products before a loan licence
- Drug License in India
What Our Clients Say
I had great experience working with Regovex Consulting on the regulatory side of my product. Since the product category was relatively new and the guidelines were not very clearly defined, it required additional research and careful interpretation of the regulations. — Parichit Dhawan, Director, Feorah Wellness & Cosmetics
I got my Drug Wholesale License through Regovex Consulting, and Devansh and his team provided complete end-to-end support, from premises selection to timely approval. — Bilal Ahmed Khan, Founder, Medwell Pharma
Related Regulatory Pages
Need help with your application?
Our experts are ready to guide you through the process.
Other Services
Drug license in India: retail, wholesale and manufacturing licence, online filing, fees, renewal and verification by experts. Free consultation.
Get your wholesale drug license in India: Form 20B & 21B filing, competent person and premises checks, inspection support. Free consultation.
Get your retail pharmacy license in India: Form 20 & 21 filing, pharmacist documents, inspection support and approval tracking. Free consultation.
Drug manufacturing license in India: Form 25 & 28, GMP and Schedule M compliance, loan and third party manufacturing. Free consultation.
CDSCO registration in India: medical device, IVD, drug and cosmetic import approvals, fees and SUGAM filing by expert CDSCO consultants.
Medical device registration in India — Class A, B, C, D classification, CDSCO filing, MD-14/MD-15 import licenses, and IVD registration. Expert support from Regovex Consulting.
Find your question below or submit your inquiry for quick assistance.
Loan License Consultant in India: Regovex Consulting
Regovex Consulting helps pharma marketing companies, cosmetic brands and medical device companies get their loan license in India quickly and correctly. A loan license, also written loan licence, is a manufacturing licence granted to a company that has no factory of its own but makes products under its own name at the plant of an already licensed manufacturer. The brand owner holds the loan licence and controls the product; the host provides the premises, equipment, staff and testing facilities.
The loan license in pharma is granted under the Drugs Rules, 1945. Drugs other than those in Schedules C, C(1) and X are covered by a Form 25A loan license, applied for on Form 24A under Rule 69A. Schedule C and C(1) drugs, such as injectables, are covered by a Form 28A loan license, applied for on Form 27A under Rule 75A. The government fee is ₹6,000 for up to 10 items in each category, ₹300 for each extra item and ₹1,500 for each inspection. The licence is granted by the State Licensing Authority of the state where the host is located, so a brand in India with a host elsewhere gets its drug loan license from the host's state.
Ready to proceed?