Loan licence liaison · Haryana · Punjab · Himachal Pradesh · Uttarakhand
Loan Licence for Pharma in India — Form 25A and Form 28A Facilitation
Manufacture under your own brand at a licensed host facility, without owning a plant. We carry out our own research, vet the host facility independently, and deal directly with the State Licensing Authority and the host manufacturer on your behalf — for distributors, PCD firms and marketing companies across Haryana, Punjab, Himachal Pradesh, Uttarakhand and pan-India.
This is a liaison-led facilitation service, not a documentation-only service. We do not hand you a checklist and send you to the department.
- Haryana
- Punjab
- Himachal Pradesh
- Uttarakhand
Every figure on this page is cited to the Drugs and Cosmetics Rules, 1945 as amended, and to published State Drugs Control fee schedules. Where the Rules are silent, we say so.
The framework
What a pharma loan licence is, and which form applies
A loan licence is issued to an applicant who does not have their own manufacturing arrangements but intends to use the manufacturing facilities of an existing licensee. The applicant is the loanee; the facility owner is the host manufacturer. The loanee holds the licence and carries the regulatory responsibility for the product; the host provides premises, plant, technical staff and quality systems.
Find your route
Select the product category you intend to manufacture. Picking the wrong route is the most common reason an application is returned.
Tablets, capsules, oral liquids, ointments and most general formulations
This is the standard loan licence route. The application covers up to ten items for each category of drugs as categorised in Schedule M; items beyond that attract a per-item fee.
Parenterals, sera, vaccines and other Schedule C and C(1) drugs, excluding Schedule X
Note the suffix. Form 28 without the “A” is an ordinary manufacturing licence for an applicant’s own premises, not a loan licence — a distinction several widely circulated guides get wrong.
Schedule X drugs are outside the loan licence route
Both loan licence forms expressly exclude drugs specified in Schedule X. Manufacture of Schedule X drugs requires a licence on your own premises and separate record-keeping and storage controls.
Medical devices sit under the Medical Devices Rules, 2017
Different rules, different forms, different authority. Device loan licences are outside the scope of this page — ask us separately if that is what you need.
The application succeeds or fails on the host facility. Before granting a loan licence, the licensing authority must satisfy itself that the host manufacturing unit has adequate equipment, staff, manufacturing capacity and testing facilities for the products applied for. Your own documents are the easy part — which is why we assess the host ourselves rather than take its word for it.
Fit
Who a loan licence suits — distributors, PCD firms and marketing companies
Distributors and wholesalers
Moving from trading into owned brands, and wanting the manufacturing permission in your own name rather than buying finished goods on a third-party invoice.
PCD and franchise brand owners
You have built a territory network and now need brand ownership to sit on the licence itself, not only on the carton.
Marketing companies
Already named on drug labels, and since 1 March 2021 carrying statutory responsibility for product quality under Rule 84E. A loan licence aligns the regulatory position with the commercial reality.
Exporters
Where the buyer, tender or registration dossier requires the manufacturing permission to be held by the exporting entity.
When it is the wrong route. A loan licence does not fit if you intend to manufacture Schedule X drugs, if you have no host facility identified, or if you want a purely arm’s-length purchase arrangement. In that last case ordinary third-party manufacturing is simpler and cheaper, and we will tell you so at feasibility stage rather than after you have paid a fee.
Decision
Loan licence, third-party manufacturing or PCD — which model fits
Swipe the table sideways on a phone.
| Consideration | Loan licence | Third-party manufacturing | PCD franchise |
|---|---|---|---|
| Who holds the manufacturing licence | You, in Form 25A or 28A | The manufacturer | The manufacturer |
| Brand ownership | You | Usually you | The franchisor |
| Statutory quality responsibility | You, as licensee | Manufacturer, plus you as marketer under Rule 84E | Manufacturer |
| Regulatory filing burden | High | Low | Minimal |
| Typical entry capital | Moderate | Low to moderate | Low |
| Control over batch scheduling and specifications | High | Moderate | Low |
Third-party manufacturing is the broader commercial term; a loan licence is a specific, formally licensed subset of it. Choose the loan licence when you need the permission in your own name — for tenders, exports, registrations, or because you want direct control of the product file.
Why us
A liaison service, not a documentation service
Most providers prepare your file and send you to the department. We do our own research and deal with the State Licensing Authority and the host manufacturer directly, on your behalf, from feasibility through to grant.
We research and vet the host ourselves
We do not accept a host’s self-declaration. We independently verify the existing manufacturing licence and its endorsed categories, look at the sections you will actually use, and assess Revised Schedule M status, equipment fit and genuinely free capacity before you sign anything.
We deal with the drug control office in person
Scrutiny queries, observations and inspection scheduling are handled by us with the concerned State Drug Control office — not advised on from a distance and left for you to chase.
We negotiate on your side of the table
Product lists, batch sizes, quality responsibilities and the loan licence agreement itself are settled with the host manufacturer with your interests represented, not the facility’s.
23+ years on the inspected side
Our founder has been through one MHRA inspection, four WHO-GMP audits and approximately ten State FDA inspections, across all major dosage forms. We prepare files and face inspectors knowing how both are read.
An actual host network in the four core states
We run a pharma plant brokerage and third-party manufacturing desk across Haryana, Punjab, Himachal Pradesh and Uttarakhand. If you have no host yet, we shortlist facilities by dosage form and location rather than sending you to look.
We say when the Rules are silent
No invented approval timelines, no invented fee figures. Where State practice varies, we confirm the position with the State Licensing Authority before you commit money to it.
Track record
What stands behind the service
Years of practice in pharmaceutical quality assurance, quality control and drug regulatory affairs.
MHRA inspection, WHO-GMP audits and State FDA inspections respectively, faced first-hand across all major dosage forms.
Core states covered on the ground — Haryana, Punjab, Himachal Pradesh and Uttarakhand — plus pan-India on a case basis.
The figures above describe our founder’s direct professional experience. We do not publish client or case counts we cannot evidence.
Method
Our loan licence process, step by step
Feasibility and route determination
We classify every product against Schedules C, C(1) and X to establish whether you are on the Form 24A route or the Form 27A route, and flag anything that falls outside loan licensing altogether.
Independent host facility research and vetting
We verify the host ourselves: existing manufacturing licence and the categories and dosage forms endorsed on it, Revised Schedule M compliance status, equipment suitability, and genuinely available capacity as opposed to claimed capacity.
Agreement negotiation with the host
A product-specific loan licence agreement, negotiated with the host on your behalf. Where you will also be named on the label as marketer, this is drafted to sit correctly alongside the Rule 84D marketing agreement.
Dossier assembly
Loanee-side constitution and identity documents; host-side site master file, technical staff credentials, plant and equipment lists, and product-wise specifications and test methods.
Filing and liaison on ONDLS
Submission through the Online National Drugs Licensing System at statedrugs.gov.in, or the concerned State’s own portal where it operates separately, with fee remittance — then direct follow-up with the drug control office through scrutiny.
Inspection attendance and reply drafting
We prepare the host unit and your technical staff for the joint inspection, attend where permitted, and draft the compliance replies to any observations raised.
Grant and post-grant compliance
On grant of Form 25A or Form 28A, we hand over a compliance calendar covering the licence retention cycle, the periodic compliance-verification inspection, endorsement of additional items, and labelling obligations.
Preparation
Documents required for a pharma loan licence
Tick items off as you gather them. Nothing is stored or transmitted — this resets when you leave the page.
0 of 19 documents ready
State Licensing Authorities differ on supporting documents and formats. Treat this as the working baseline — we confirm the concerned State’s current checklist with the department directly before filing.
Cost and duration
Loan licence fees and timelines — what the Rules actually say
Statutory fees
The central fee is identical for both loan licence routes.
| Item | Amount | Provision |
|---|---|---|
| Licence fee, application in Form 24A or 27A, up to 10 items per Schedule M category | ₹6,000 | R. 69A(1) / 75A(1) |
| Inspection fee, per inspection | ₹1,500 | R. 69A(1) / 75A(1) |
| Each additional item beyond ten per category | ₹300 | R. 69A(3) / 75(5) |
| Duplicate copy of a defaced, damaged or lost licence | ₹1,000 | R. 69A(4) / 75A(4) |
| Licence retention, each five-year cycle | ₹6,000 + ₹1,500 | G.S.R. 1337(E) |
| Late retention penalty | 2% p.m. | G.S.R. 1337(E) |
Statutory fee estimator
Both loan licence routes carry the same central fee, so the estimate is the same whether you file Form 24A or Form 27A.
- Licence fee₹6,000
- Inspection fee₹1,500
- Additional items₹0
- Retention due at each 5-year point₹7,500
- Late retention penalty, per month₹120
Assumptions, stated openly.
1. Figures are the central statutory fees prescribed under the Drugs and Cosmetics Rules, 1945. State portal charges, document handling and our professional fees are separate and not included.
2. The licence fee is modelled as one charge per application. Some State Licensing Authorities levy it per Schedule M category instead. We confirm the position with the concerned State before you remit.
3. The late penalty is 2% of the licence fee per month or part month, applicable for up to six months.
4. This is an indicative estimate, not a quotation.
Validity — the point most published guidance still gets wrong
Since G.S.R. 1337(E) dated 27 October 2017, renewal of manufacturing licences was removed. A loan licence in Form 25A or Form 28A now remains valid perpetually unless suspended or cancelled, subject to payment of a licence retention fee before the expiry of every succeeding five-year period from the date of issue. Late payment attracts a late fee of 2% of the licence fee per month or part month for up to six months. Separately, compliance with the conditions of licence is verified by joint inspection not less than once in every three years, or more often on a risk-based approach.
Guidance still describing a loan licence as “valid for five years and renewable” is describing the pre-2017 position. Several of the highest-ranking pages on this topic still do.
Timeline
The Drugs and Cosmetics Rules, 1945 do not prescribe a statutory period within which a loan licence must be granted. Published ranges you will find elsewhere are practitioner estimates, not legal entitlements. Actual elapsed time is driven by three things: the completeness of the host-side dossier, the inspection scheduling load at the concerned State office, and how quickly observations are answered. Because we deal with the department directly, we give you a realistic State-specific expectation at feasibility stage rather than a number on a webpage.
Jurisdiction
Where we work — Haryana, Punjab, Himachal Pradesh and Uttarakhand
Loan licences are granted by the State Licensing Authority of the State where the host manufacturing facility is located, not where your office is registered. If your host is in Baddi, you file in Himachal Pradesh regardless of where you are based — which is why our presence in the manufacturing states matters more than our postal address.
Our four core states
Haryana
Our home state. The first in the country to issue a drug manufacturing licence online through ONDLS.
- Karnal
- Panchkula
- Ambala
- Sonipat
- Gurugram
- Faridabad
Punjab
Established formulation and contract manufacturing base adjoining the Himachal belt.
- Mohali
- Derabassi
- Ludhiana
- Jalandhar
Himachal Pradesh
The Baddi–Barotiwala–Nalagarh belt is among India’s largest pharmaceutical manufacturing clusters.
- Baddi
- Barotiwala
- Nalagarh
- Paonta Sahib
- Kala Amb
- Solan
- Una
Uttarakhand
The Haridwar–Rudrapur corridor, built on the same 2003 industrial package as Himachal Pradesh.
- Haridwar
- Roorkee
- Rudrapur
- Pantnagar
- Selaqui
- Dehradun
Why Himachal Pradesh and Uttarakhand matter for loan licence seekers. The 2003 central industrial package gave new units in these hill states a ten-year central excise exemption and a five-year income tax holiday. Those incentives have since lapsed, but the manufacturing base they created did not — the Baddi–Barotiwala–Nalagarh belt and the Haridwar–Rudrapur corridor still carry a dense concentration of licensed units. For a loanee, that density is the practical point: more candidate host facilities, more dosage forms already endorsed on existing licences, and enough choice to select a host on compliance quality rather than on whoever happens to be nearby.
Also handled, on a case basis
- Delhi NCR
- Uttar Pradesh
- Rajasthan
- Gujarat
- Madhya Pradesh
- Other States on request
Most States accept manufacturing licence applications, including Forms 24A and 27A, through the Online National Drugs Licensing System (ONDLS) at statedrugs.gov.in, developed by C-DAC with CDSCO under the One Nation One Drug Licensing System initiative. If you have not yet identified a host facility, see our pharma plant and facility listings, or our regulatory compliance consultation for wider licensing support.
Questions
Loan licence FAQs
A loan licence is a manufacturing licence issued under the Drugs and Cosmetics Rules, 1945 to an applicant who does not have their own manufacturing arrangements but intends to use the manufacturing facilities of an existing licensee. The applicant is called the loanee and holds the licence; the facility owner is called the host manufacturer and provides the premises, plant, technical staff and quality systems.
For drugs other than those specified in Schedules C, C(1) and X, the application is made in Form 24A under Rule 69A and the licence is granted in Form 25A. For drugs specified in Schedules C and C(1), excluding those in Schedule X, the application is made in Form 27A under Rule 75A and the licence is granted in Form 28A. Form 25 and Form 28 without the A suffix are ordinary manufacturing licences, not loan licences.
The central statutory fee is a licence fee of 6,000 rupees plus an inspection fee of 1,500 rupees for every inspection, for both the Form 24A and the Form 27A route. An application covers up to ten items for each category of drugs categorised in Schedule M, and each additional item beyond that attracts a further 300 rupees. A duplicate copy of a lost or damaged licence costs 1,000 rupees. State portal charges and professional fees are separate.
Since notification G.S.R. 1337(E) dated 27 October 2017, renewal of manufacturing licences was removed and a loan licence in Form 25A or Form 28A remains valid perpetually unless suspended or cancelled. Validity is subject to payment of a licence retention fee before the expiry of every succeeding five-year period from the date of issue, with a late fee of 2 per cent of the licence fee per month or part month. Compliance with licence conditions is verified by inspection not less than once in every three years, or more often on a risk-based approach.
Third-party manufacturing is a broad commercial term for outsourcing production to another company. A loan licence is a specific, formally licensed subset of it, in which the brand owner holds a manufacturing licence in their own name in Form 25A or Form 28A and carries the licensee's regulatory responsibility. In ordinary third-party manufacturing, the manufacturing licence remains with the manufacturer and the brand owner buys finished goods.
Yes. A marketing company that does not own a manufacturing facility can apply for a loan licence and use a host manufacturer's premises. Separately, since the Drugs and Cosmetics (Amendment) Rules, 2020 came into force on 1 March 2021, a marketer whose name appears on a drug label must have a marketing agreement with the manufacturer under Rule 84D and is responsible for the quality of that drug alongside the manufacturer under Rule 84E. The marketer's name and address must appear on the label under Rule 96.
Application is made to the State Licensing Authority of the State in which the host manufacturing facility is located, not the State in which the applicant's office is registered. Most States accept applications in Form 24A and Form 27A through the Online National Drugs Licensing System at statedrugs.gov.in, developed by the Centre for Development of Advanced Computing with the Central Drugs Standard Control Organisation. Some States continue to operate their own portals in parallel.
Next step
Tell us your products. We will do the research.
Send your product list and, if you have one, your host facility details. We will confirm which route applies, flag anything that cannot go on a loan licence, and come back with a State-specific view — after checking with the department and the host, not from a template.
Laafon Galaxy Pharmaceuticals · #33/4, Rajiv Puram, Phoosgarh Road, Karnal — 132001, Haryana · +91 98124 46733 · contact@laafon.com
Loan licence feasibility enquiry
Five fields. We reply within one working day.