A pharmaceutical or cosmetic business does not always need to establish its own manufacturing factory before launching products in India. Depending on the regulatory structure, an applicant may use the manufacturing facilities of an existing licensed manufacturer through a loan licence.
The important part is choosing the correct licensing route.
There is no single universal “CDSCO loan licence” form for every pharmaceutical and cosmetic product. Pharmaceutical applications may involve Form 25A, Form 28A or Form 28DA, depending on the drug category, while cosmetics follow the separate COS-6 to COS-9 route under the Cosmetics Rules, 2020.
A business that selects its manufacturing partner first and investigates the regulatory route later can discover that the host facility does not have the correct licence, product category, equipment, testing capability or approval required for the proposed product.
That is why loan-licence planning should begin before the manufacturing agreement is finalised.
Under the Drugs Rules, a loan licence allows an applicant to manufacture drugs for sale or distribution by using manufacturing facilities belonging to an existing licensed manufacturer.
For the Form 25A route, the rules describe the applicant as using facilities owned by a licensee in Form 25. The Licensing Authority must be satisfied that the manufacturing unit has sufficient equipment, staff, manufacturing capacity and testing facilities to manufacture on behalf of the loan-license applicant.
The same basic principle applies to relevant Schedule C/C(1) drug categories through the Form 28A/28DA framework.
For cosmetics, a business seeking a loan licence applies in Form COS-6, with the loan licence granted in Form COS-9.
In practical terms, a loan licence can be useful for a company that wants to own or market its product portfolio while using an already established manufacturing facility rather than immediately investing in its own plant.
This is an important distinction.
Businesses frequently search for terms such as “CDSCO loan licence”, but manufacturing loan-licence applications are not all simply filed with CDSCO headquarters.
For cosmetics, the Cosmetics Rules expressly require the application to be made to the State Licensing Authority.
For pharmaceutical drugs, licensing functions operate under the Drugs Rules through the competent Licensing Authority, with State Drugs Control organisations playing the key role in manufacturing licensing. Central regulatory involvement can also arise for particular categories, new drugs and joint inspections.
The current ONDLS system itself lists the major manufacturing-loan-licence services, including Form 24A→25A, Form 27A→28A, Form 27DA→28DA and COS-6→COS-9.
Therefore, the first task should be to identify the product category, applicable rules and competent authority, rather than simply searching for a generic CDSCO application.
| Product category | Application | Loan licence | Typical host manufacturing licence |
| Drugs other than Schedules C, C(1) and X | Form 24A | Form 25A | Form 25 |
| Relevant Schedule C/C(1) drugs excluding specified Part XB/Schedule X categories | Form 27A | Form 28A | Form 28 |
| Large Volume Parenterals, sera, vaccines and r-DNA-derived drugs | Form 27DA | Form 28DA | Corresponding Form 28D facility |
| Cosmetics | Form COS-6 | Form COS-9 | Form COS-8 |
The first three routes are reflected in the Drugs Rules and the current ONDLS services.
The standard Form 25A and Form 28A provisions expressly exclude Schedule X. A Schedule X product therefore requires a separate product-category and licensing assessment instead of being placed into the normal 25A/28A route.
This classification check should happen before documents or fees are prepared.
These expressions are related, but they should not be treated as interchangeable.
Third-party or contract manufacturing describes a commercial arrangement under which one company manufactures products for another.
A loan licence is a statutory licensing structure under the applicable drug or cosmetic regulations.
Signing a private manufacturing agreement does not by itself replace the statutory licence required where the applicant intends to operate as a loan licensee.
The Drugs Rules also separately regulate the relationship between a marketer and the manufacturer. Current provisions require an agreement in specified marketer arrangements and make the marketer responsible along with the manufacturer for quality and regulatory compliance.
For this reason, the commercial agreement and the regulatory licensing structure should be reviewed together rather than as two unrelated exercises.
Many applicants focus heavily on their own company documents but underestimate the importance of the host manufacturer.
For pharmaceutical loan licences, the Licensing Authority must be satisfied that the manufacturing facility has adequate:
This requirement appears directly in the loan-licence provisions of the Drugs Rules.
Pharmaceutical facilities must also comply with applicable Schedule M Good Manufacturing Practices and requirements for premises, plant and equipment.
Before entering into a long-term manufacturing agreement, verify:
| Check | Why it matters |
| Correct manufacturing licence | The host’s licence must correspond to the product category. |
| Approved dosage form/category | A valid licence alone does not mean every proposed product can automatically be manufactured. |
| Manufacturing equipment | Equipment must be suitable for the proposed operations. |
| Testing capability | Required quality-control arrangements must be available. |
| Production capacity | Authority can examine whether the host has capacity to manufacture for the loan licensee. |
| GMP status | Pharmaceutical manufacture must operate within applicable Schedule M requirements. |
| Licence status | Suspension or cancellation can directly affect the loan licence. |
| Product-specific approvals | New drugs or other specially regulated products may need prior approval. |
This host-facility review is one of the most important pre-filing steps.
A loan licence is not independent of the host manufacturing facility.
Under Rule 74B, a Form 25A loan licence is deemed cancelled or suspended if the underlying Form 25 licence of the facility being used is cancelled or suspended.
A similar dependency applies to Forms 28A and 28DA through Rule 78A.
For cosmetics, Rule 26 provides that a COS-9 loan licence is deemed cancelled or suspended if the relevant manufacturing facility’s COS-8 licence is cancelled or suspended.
This makes regulatory due diligence on the manufacturing partner important not just during application but throughout the commercial relationship.
Pharmaceutical requirements depend on the product category, state implementation and application route. Applicants should therefore avoid using a generic online checklist as if it applies identically across India.
A typical readiness exercise should cover:
For branded pharmaceutical products, the Drugs Rules also contain an undertaking requirement in Form 51 relating to the proposed brand/trade name.
Where the formulation falls within the new-drug framework, the required new-drug approval must be addressed before the corresponding manufacturing licence is granted.
The Cosmetics Rules provide a more defined document framework.
Part II of the Second Schedule includes, among other things:
The exact dossier should still be checked against the relevant State Licensing Authority and current portal workflow before submission.
A new cosmetic requires an additional central regulatory step.
Rule 23 states that the applicant must obtain prior permission in Form COS-3 from the Central Licensing Authority before the State Licensing Authority grants the manufacturing licence.
The Cosmetics Rules provide for application for such prior permission in Form COS-12, with permission issued in COS-3 after the Central Licensing Authority is satisfied regarding safety and effectiveness.
Applicants should therefore classify the product before filing COS-6.
Determine whether the product is:
This determines almost every step that follows.
Map the product to Form 24A, Form 27A, Form 27DA or COS-6 as applicable.
Review the host licence, approved product scope, GMP status, technical staff, manufacturing equipment, testing capability and capacity.
Check whether the proposed formulation requires new-drug approval, new-cosmetic permission or another product-specific approval.
Compile legal, technical, product, manufacturing and quality documents.
Applications may be handled through ONDLS or the applicable state regulatory system depending on the service and jurisdiction. ONDLS currently lists the major pharmaceutical and cosmetic loan-licence routes.
For pharmaceutical manufacturing routes, current Drugs Rules provide for inspection of manufacturing establishments and ongoing risk-based compliance verification.
For cosmetics, Rule 23 provides a post-grant inspection mechanism to verify the COS-7 self-certification.
Respond to queries with consistent documents and ensure that any changes to the product, manufacturing facility, constitution or technical arrangements are properly addressed.
Track retention-fee dates, approved products and amendments throughout the licence lifecycle.
Under the current Drugs Rules:
Form 24A / Form 25A route
Form 27A / Form 28A route
Form 27DA / Form 28DA route
These are government regulatory fees under the cited rules. Consulting, documentation, testing, product-development and other commercial costs are separate and depend on the scope of work.
The Third Schedule to the Cosmetics Rules prescribes:
The same schedule contains the applicable COS-9 retention fees.
A single nationwide pharmaceutical approval timeline should not be promised.
The actual duration can depend on:
For cosmetics, there is a specific statutory process. Rule 23 states that, when the prescribed application, fee and documents are submitted and requirements are fulfilled, the State Licensing Authority shall grant the licence or loan licence within 45 days; where requirements are not fulfilled, the deficiencies are to be communicated within that period. The Rules also provide for verification of the manufacturing site after grant.
Green Permits should not advertise guaranteed approval dates because regulatory decisions remain with the competent authority.
Older online content may still describe drug manufacturing licences simply as “valid for five years”. That is incomplete under the current framework.
A Form 25A loan licence remains valid subject to payment of the prescribed retention fee before completion of every succeeding five-year period, unless suspended or cancelled. The retention fee corresponds to the grant fee excluding the inspection fee. Late-payment provisions also apply.
The same retention structure applies to Forms 28A and 28DA.
Therefore, the five-year point is primarily a retention-fee compliance milestone, not an automatic expiry requiring an entirely new licence application.
A COS-9 licence remains valid in perpetuity, subject to payment of the prescribed retention fee before completion of every five-year period and unless it is suspended or cancelled.
Where the retention fee is not paid on time, the Cosmetics Rules provide for a late fee for up to 180 days; continued non-payment results in deemed cancellation.
For example, treating every pharmaceutical formulation as a Form 25A case without checking Schedule C/C(1) status.
A factory being “drug licensed” does not automatically make it suitable for every dosage form or product.
The Rules expressly require the authority to evaluate manufacturing capability for pharmaceutical loan licences.
A manufacturing-loan-licence application does not replace a required prior product approval.
Formulation, product name, dosage form, proposed label and host documentation should tell the same regulatory story.
Changes in company constitution, address, brand ownership or authorised signatory can create avoidable deficiencies.
For pharmaceuticals, Schedule M compliance is an operational manufacturing requirement, not merely a document to attach.
Applications for cosmetic loan licences now use COS-6 and COS-9, not legacy forms from the earlier regime.
| Area | Loan-licence applicant | Host manufacturer |
| Correct regulatory route | Must determine and apply | Must hold compatible manufacturing authorisation |
| Product documentation | Applicant-specific dossier must be accurate | Must support manufacturing feasibility |
| Equipment and premises | Review before engagement | Must maintain compliant facility |
| Manufacturing capacity | Confirm allocation | Must demonstrate adequate capacity |
| Quality/testing | Agree responsibilities and records | Must maintain applicable testing arrangements |
| GMP | Must ensure chosen partner is suitable | Must operate compliant manufacturing system |
| Regulatory inspection | Must cooperate as applicable | Facility is subject to inspection |
| Licence status | Must monitor dependency | Must maintain underlying manufacturing licence |
| Commercial agreement | Applicant responsibility jointly with counterparty | Must clearly define manufacturing/quality obligations |
Before filing, answer yes to each relevant question:
If several answers are “no”, application preparation should normally begin with a compliance-gap review rather than immediate filing.
Green Permits can support pharmaceutical and cosmetic businesses with the regulatory work surrounding a loan-licence application, including:
The objective is not merely to upload forms. It is to identify regulatory issues before they become application deficiencies.
The loan-licence framework is specifically designed around using the manufacturing facilities of another appropriately licensed manufacturer. The proposed host must meet the applicable regulatory conditions, including adequate equipment, staff, capacity and testing facilities.
It depends on the drug category. Common routes include Form 24A→25A, Form 27A→28A and Form 27DA→28DA.
The application is made in Form COS-6, and the loan licence is issued in Form COS-9.
Rule 23 requires the manufacturing or loan-licence application to be submitted to the State Licensing Authority. CDSCO/Central Licensing Authority has separate responsibilities, including prior permission for a new cosmetic.
No. Third-party manufacturing describes the commercial arrangement. A loan licence is a regulatory permission under the applicable rules. The commercial agreement should therefore be structured alongside, not instead of, the required regulatory approvals.
For Form 25A, 28A and 28DA, current rules provide continuing validity subject to payment of retention fees every succeeding five years unless the licence is suspended or cancelled.
COS-9 similarly remains valid in perpetuity subject to its five-year retention-fee requirement.
The effect can be direct. Forms 25A, 28A and 28DA depend on the relevant host manufacturing licence, and the Rules provide for corresponding cancellation or suspension where that underlying licence is cancelled or suspended. COS-9 has a comparable dependency on the host’s COS-8 licence.
No consultant should guarantee a regulatory approval. The competent Licensing Authority makes the decision. Green Permits can help improve application readiness, identify gaps, prepare the dossier and manage the compliance process.
If you are planning to manufacture pharmaceutical products or cosmetics through another licensed manufacturing facility, confirm your regulatory route before signing the final manufacturing arrangement or filing an application.
Green Permits can review your product category, proposed manufacturer, existing licences and documents to identify the appropriate application route.
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