Manufacturing Drug License in India – Requirements, Forms, Fees and Process
A Manufacturing Drug License is the statutory authorisation required to manufacture specified pharmaceutical drugs for sale or distribution in India. The licensing process depends on the products, manufacturing premises, technical staff, testing arrangements and applicable quality standards under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
For many conventional allopathic products, the relevant application and licence pairs are Form 24 and Form 25, or Form 27 and Form 28. Different forms and additional permissions may apply to specialised medicines, loan licensing and other manufacturing activities.
Legal Papers India Business Solution Private Limited is a private business-registration and compliance consultancy. Businesses planning pharmaceutical manufacturing may contact the company to discuss their requirements, confirm the availability of relevant assistance and request a quotation.
Planning a pharmaceutical manufacturing facility? Contact Legal Papers India to discuss the proposed products, manufacturing model and licensing requirements.
What Is a Manufacturing Drug License?
A Manufacturing Drug License permits the manufacture of specified drugs for sale or distribution, subject to the categories, premises and conditions approved by the competent licensing authority.The governing framework includes the Drugs and Cosmetics Act, 1940, the Drugs Rules, 1945 and applicable amendments and notifications.
Manufacturing approval is not a general permission to produce every pharmaceutical product. The licence and related product permissions must cover the proposed activities.A business may also need to comply with Good Manufacturing Practices, obtain additional product-specific approvals and meet environmental, fire-safety and other applicable requirements.
Types of Drug Manufacturing Licenses in India
The correct application depends on the proposed product and manufacturing arrangement.
| Application form |
Corresponding licence |
General purpose
|
| Form 24 |
Form 25 |
Manufacture of drugs outside Schedules C, C(1) and X
|
| Form 27 |
Form 28 |
Relevant Schedule C/C(1) drugs, subject to specified exclusions
|
| Form 24A |
Form 25A |
Loan licence for relevant ordinary drug categories
|
| Form 27A |
Form 28A |
28A Loan licence for relevant Schedule C/C(1) categories
|
| Form 24B |
Form 25B |
Repacking of specified eligible drugs
|
| Form 24F |
Form 25F |
Relevant Schedule X manufacturing categor
|
| Form 27B |
Form 28B |
Relevant specialised scheduled-drug manufacturing category
|
| Form 30 |
Form 29
|
Manufacture for examination, test or analysis |
These are common form routes, not an exhaustive list of every pharmaceutical permission.
Form 24 and Form 25
Form 24 is the application route for manufacturing drugs other than those specified in Schedules C, C(1) and X, where applicable.
Form 25 is the corresponding manufacturing licence.
Form 27 and Form 28
Form 27 is used for specified drugs in Schedules C and C(1), subject to the applicable exclusions.
Form 28 is the corresponding licence.
The applicant should not assume that every biological product follows an identical procedure or is approved by the same authority.
Loan Manufacturing Licences : Loan licensing may allow an eligible applicant to use the manufacturing facilities of another appropriately licensed manufacturer under the prescribed conditions. The licensing authority must be satisfied that the arrangement meets the applicable requirements.
Repacking Licences : Repacking can constitute a regulated manufacturing activity under the Drugs Rules. Businesses should verify whether the proposed activity falls under a repacking licence rather than assuming it is covered by a trading or wholesale licence.
Which Authority Issues a Drug Manufacturing License?
The relevant State or Union Territory Drugs Control Licensing Authority generally handles manufacturing licence applications under the applicable framework. CDSCO and the Central Licensing Authority also have roles in specified products and permissions, including categories requiring central approval or coordinated regulatory action.
The precise route depends on the product classification and governing rules. For example, an ordinary manufacturing licence and permission to manufacture a new drug are not necessarily the same approval.
The applicant should identify both the facility-licensing authority and any additional product-approval authority before submitting an application.
Eligibility Requirements for Manufacturing Drug License Registration
Eligibility involves more than registering a company or renting industrial premises. The applicant must establish that the manufacturing operation can satisfy the requirements for its proposed products.
Suitable Business Structure : The applicant may operate through an eligible proprietorship, partnership, LLP, company or other permitted structure. Supporting constitution and authorisation documents are required according to the applicant's legal form.
Appropriate Manufacturing Premises : The facility must be suitable for the proposed pharmaceutical operations and comply with applicable premises and manufacturing standards. The required layout, segregation, utilities and equipment depend on the products and processes.
Qualified Technical Personnel : Manufacturing and testing activities require appropriately qualified technical staff under the applicable licence conditions. The necessary qualifications and experience must be assessed under the relevant Rules.
Testing and Quality-Control Arrangements : The applicant must demonstrate adequate testing and quality-control arrangements. The applicable framework may permit particular testing arrangements through approved facilities, subject to regulatory conditions.
Manufacturing and Quality Systems : The proposed facility must be capable of complying with applicable Good Manufacturing Practices and maintaining appropriate manufacturing records, procedures and quality controls.
Revised Schedule M Requirements for Pharmaceutical Manufacturers : Schedule M sets out Good Manufacturing Practices and requirements concerning premises, plant, equipment and pharmaceutical quality systems. The revised Schedule M was notified in December 2023.
The government implemented the revised requirements for large manufacturers from June 2024 and later provided a conditional extension for eligible smaller manufacturers.
What Changed Under Revised Schedule M?
The revised framework places emphasis on pharmaceutical quality systems, manufacturing controls, documentation, risk management, equipment and facility suitability, validation, contamination prevention and other product-quality safeguards.
The exact controls depend on the manufacturing operation.
Does Schedule M Apply to a New Manufacturing Unit?
A new applicant should plan its facility and quality systems against the currently applicable requirements. A business should not rely on historical transition periods intended for existing manufacturers without confirming its eligibility and the current law.
Premises and Infrastructure Requirements : There is no responsible single shop-area figure that can be applied to every pharmaceutical manufacturing plant.
Requirements depend on the proposed dosage forms, manufacturing processes, product categories, equipment, storage and quality-control arrangements.
Manufacturing Layout : The layout should support appropriate material and personnel movement, segregation and contamination-control arrangements.
Equipment and Utilities : Machinery, water systems, environmental controls and other utilities must be appropriate to the intended manufacturing activities.
Quality-Control Facilities : Testing facilities and laboratory arrangements must meet the applicable requirements.
Storage Areas : Raw materials, packaging materials, finished products and other stock categories must be stored under suitable conditions.
Environmental and Fire Requirements : Separate approvals may apply depending on the State, location and manufacturing process. For example, Delhi's Drugs Control Department identifies pollution-control documentation for drug manufacturing industries and fire-related requirements for specified operations involving inflammable materials.
Applicants should confirm the current requirements for their actual industrial location.
Documents Required for Manufacturing Drug License Registration
The document checklist varies by State or Union Territory, product category, manufacturing arrangement and licence form.
The following groups are commonly relevant.
Applicant and Business Documents
- Business constitution or incorporation documents.
- Authorisation of the applicant or signatory.
- Prescribed application form.
- Declarations and affidavits required by the authority.
- Government fee payment records.
Premises Documents
- Ownership, lease or lawful occupancy evidence.
- Site plan and key plan.
- Manufacturing facility layout.
- Details of production, storage and testing areas.
- Applicable industrial-use, pollution-control or fire-related approvals.
Technical Personnel Documents
- Qualification certificates.
- Experience records.
- Appointment documents.
- Details of responsibilities and supervisory arrangements.
Manufacturing and Quality Documents
- Proposed product and formulation details.
- Manufacturing process and equipment information.
- Details of testing facilities and laboratory equipment.
- Quality-system and GMP documentation.
- Site Master File, where prescribed.
- Relevant validation, cleaning, maintenance and control documents.
Additional Product-Specific Documents
Specialised products may require further technical data, approvals or evidence. An applicant should not use a generic Form 27 checklist for every Form 24 application, or vice versa.
Before filing: Obtain the current checklist for the exact licence category from the responsible government authority.
How to Apply for a Manufacturing Drug License Online
The application process depends on the State or Union Territory and the drug category.
The official Online National Drugs Licensing System supports a range of manufacturing applications. Other CDSCO workflows may apply where central permissions are required.
Step 1: Classify the Proposed Products : Identify the active ingredients, formulations, dosage forms and applicable schedules. Determine whether additional new-drug or specialised permissions are required.
Step 2: Select the Manufacturing Model : Decide whether the business will operate its own manufacturing facility, seek a loan licence or undertake another separately regulated activity.
Step 3: Identify the Licensing Authorities : Confirm the relevant State/UT licensing route and any required CDSCO involvement.
Step 4: Assess Facility Readiness : Review the premises, manufacturing layout, utilities, equipment, technical staff, testing facilities and applicable Schedule M requirements.
Step 5: Prepare the Documentation : Collect the applicant, premises, technical-personnel, product and quality-system records. Use the prescribed application form for the selected category.
Step 6: Submit the Official Application : Apply through the applicable government portal or prescribed filing route. Pay the statutory fees and retain the acknowledgement.
Step 7: Complete Regulatory Scrutiny and Inspection : The authority may review the documents, inspect the facility, assess manufacturing and testing arrangements, and raise deficiencies. The applicant must provide accurate responses and complete any required corrective action.
Step 8: Obtain the Licensing Decision : The competent authority decides whether the applicable requirements have been met. Approval may specify manufacturing premises, product categories and other licence conditions.
The applicant should not commence regulated commercial manufacture merely because an application has been filed.
Manufacturing Drug License Government Fees in India
Government fees depend on the manufacturing category, application form, number and type of products, inspection provisions and current applicable rules. It would be misleading to quote one universal government fee for every manufacturing drug licence.
The total cost can include several distinct components.
| Cost component |
Basis |
| Government application/licence fee |
Prescribed category and current fee schedule |
| Additional product fees |
Where applicable |
| Inspection-related charges |
Where prescribed |
| Manufacturing premises |
Facility and infrastructure requirements |
| Equipment and utilities |
Product/process-specific |
| Technical personnel |
Applicable staffing requirements |
| Quality-control and GMP systems |
Facility requirements |
| Environmental/fire approvals |
Jurisdiction and process
|
| Professional consultancy |
Separate agreed quotation |
Legal Papers India has not supplied a verified professional fee for this service.
Contact Legal Papers India to enquire about the availability of assistance and request a quotation that separates professional fees from statutory charges.
How Long Does Drug Manufacturing License Registration Take?
Manufacturing licence processing does not have one universal approval timeline across all products and jurisdictions. The overall project may involve site selection, plant design, construction, equipment qualification, technical staffing, quality-system preparation, application scrutiny and regulatory inspection.
A facility that is not ready for inspection may require substantially more preparation than an applicant with compliant premises and complete documentation. State authorities may publish administrative service standards, but these should not be converted into guaranteed national approval periods.
The competent authority controls the final licensing decision.
Manufacturing Drug License Validity and Retention
Relevant manufacturing licences are subject to continuing licence conditions and the applicable retention-fee framework. For specified licence categories, the Rules provide for payment of retention fees at successive five-year intervals rather than treating every licence as requiring a completely new application at each interval.
The exact rule must be checked for the relevant licence form. A licence may also be suspended or cancelled under applicable legal provisions. Manufacturers should maintain a calendar for retention payments, regulatory updates, product permissions and periodic compliance obligations.
Follow Approved Manufacturing Processes
Maintain control over approved products, manufacturing procedures, equipment and quality systems.
Maintain Batch and Testing Records : Keep the manufacturing, testing, release and distribution records prescribed for the products and licence conditions.
Manage Complaints and Recalls : Maintain appropriate systems for handling quality complaints, defective products, recalls and related regulatory obligations.
Control Changes to the Facility : Changes to premises, constitution, products, equipment or manufacturing arrangements may require prior permission, endorsement, notification or another prescribed regulatory action.
Track Licence Retention and Regulatory Updates : Maintain the required retention-fee schedule and monitor changes to the Drugs Rules, Schedule M and applicable authority directions.
Common Reasons Manufacturing Drug License Applications Face Deficiencies
Incorrect Product Classification : Selecting the wrong licence category can delay or invalidate an application.
Facility Not Ready for Inspection : Incomplete utilities, unsuitable layouts or inadequate manufacturing controls may lead to regulatory observations.
Missing Technical Staff : Required personnel must satisfy the applicable qualification and experience conditions.
Incomplete Quality-System Documents : Generic procedures that do not reflect the actual facility may be inadequate.
Missing Local Approvals : Relevant pollution-control, fire or other approvals may be necessary for the proposed operation.
Confusing a Loan Licence With a Manufacturing Contract : The correct legal arrangement must be determined from the actual facility use and regulatory responsibilities.
Assuming One Licence Covers Every Product : A manufacturing licence does not automatically cover products or activities outside its approved scope.
Manufacturing Drug License Enquiries With Legal Papers India
Planning a pharmaceutical manufacturing business requires an early assessment of the products, facility, technical personnel and regulatory route.
Legal Papers India Business Solution Private Limited is a private business-registration and compliance consultancy.
Businesses may contact the company to discuss their proposed project, confirm the availability of manufacturing-drug-licensing assistance and request a written quotation.
Details to Prepare for Your Enquiry
- State or Union Territory of the proposed manufacturing facility.
- Products and dosage forms proposed.
- Own manufacturing facility or loan-licensing model.
- Current stage of premises development.
- Proposed manufacturing and testing arrangements.
- Technical staff availability.
- Business constitution.
- Any existing regulatory permissions or application references.
-
Do not share sensitive personal documents through an unverified channel.
Contact Legal Papers India to discuss your requirements.
The competent government authority independently determines whether the manufacturing licence can be granted.
Discuss Your Manufacturing Drug License Requirements
Preparing to establish a pharmaceutical manufacturing unit or evaluate a loan-licensing arrangement? Begin by identifying the products, licence categories, manufacturing premises, technical staff, quality systems and applicable regulatory permissions.
Legal Papers India Business Solution Private Limited can receive your enquiry and confirm whether private assistance is available for your proposed project.
Contact Legal Papers India to discuss your requirements and request a quotation.
Disclaimer: Legal Papers India is a private consultancy and is not CDSCO or a State Drugs Control Licensing Authority. Government authorities make all regulatory decisions.
Official references
Ministry of Health — Schedule M Extension Announcement
Frequently Asked Questions
What is a Manufacturing Drug License in India?
A Manufacturing Drug License authorises specified pharmaceutical manufacturing activities for sale or distribution under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945. The licence depends on the drug category, approved premises, technical personnel, testing facilities and applicable quality requirements. Different products may require different forms or additional permissions.
Which form is used to apply for a Drug Manufacturing License?
Form 24 is generally used for relevant ordinary drug categories leading to Form 25. Form 27 is used for relevant Schedule C/C(1) categories leading to Form 28. Loan licensing, repacking, Schedule X drugs and other specialised manufacturing activities may use different forms. The correct form must be selected after product classification.
What is the difference between Form 25 and Form 28?
Form 25 is generally associated with manufacturing drugs outside Schedules C, C(1) and X. Form 28 covers relevant drugs specified in Schedules C and C(1), subject to exclusions. The distinction affects the application route and technical requirements. Neither licence should be treated as blanket permission to manufacture every pharmaceutical product.
Is a manufacturing licence mandatory before starting production?
Commercial manufacture of regulated drugs for sale or distribution generally requires the applicable authorisation before operations begin. The applicant must meet the relevant premises, technical-staff, testing and quality requirements. An application acknowledgement is not a licence, and a business registration certificate does not independently authorise pharmaceutical manufacturing.
What are the requirements for a pharmaceutical manufacturing plant?
Requirements depend on the products and processes. They commonly involve suitable industrial premises, an appropriate layout, manufacturing equipment, utilities, qualified technical personnel, testing facilities, quality-system documentation and applicable Good Manufacturing Practices. Additional environmental, fire-safety or product-specific approvals may also be necessary.
What is revised Schedule M?
Revised Schedule M is the updated Good Manufacturing Practices framework for pharmaceutical manufacturing under the Drugs Rules. It addresses quality systems, premises, equipment, manufacturing controls, documentation and related safeguards. The revised framework was notified in December 2023, with phased implementation and a later conditional extension for qualifying smaller manufacturers.
Is the Schedule M extension available in 2026?
The government's previously announced conditional extension for qualifying smaller manufacturers ran until 31 December 2025. That deadline has passed. Applicants should not assume the old extension remains available. Any later exemption, extension or transition provision must be verified from a current operative government notification.
What documents are needed for a Drug Manufacturing License?
Documents commonly include business constitution records, the prescribed application form, premises plans, ownership or tenancy evidence, equipment and manufacturing details, technical-staff qualifications, testing arrangements, product information and relevant GMP documentation. Additional approvals may be required according to the State, manufacturing process and product category.
How much does a Drug Manufacturing License cost?
There is no single reliable total cost for every pharmaceutical manufacturing licence. Government fees depend on the relevant form and products, while plant infrastructure, equipment, technical staffing, testing, compliance systems and professional assistance are separate costs. Applicants should verify the current official fee schedule and obtain an itemised quotation for optional consultancy services.
How long does it take to obtain a Manufacturing Drug License?
The timeframe depends on the product category, licensing authority, facility readiness, documentation, inspection and any deficiencies. Building and qualifying a new plant may take additional time before the application can be assessed. A consultant cannot guarantee a uniform nationwide approval period or control the authority's decision.
What is a pharmaceutical manufacturing loan licence?
A loan licence is a prescribed licensing arrangement that may allow an eligible applicant to manufacture drugs using the facilities of another appropriately licensed manufacturer, subject to regulatory conditions. It is not automatically created by signing a third-party manufacturing agreement. The applicant must determine the correct licence form and responsibilities.
Can a private limited company apply for a Drug Manufacturing License?
Yes. An eligible private limited company may apply if it satisfies the applicable legal requirements. It must provide its constitution and authorisation documents, establish suitable premises and technical arrangements, and meet the requirements for the proposed products. Company incorporation alone does not authorise drug manufacturing.
Is a State manufacturing licence enough to manufacture a new drug?
Not necessarily. Certain new drugs require additional central permission under the applicable regulatory framework. A manufacturing licence for the facility does not automatically replace product-specific approvals. The applicant should assess the regulatory classification and necessary permissions before starting manufacture or commercial supply.
Does a Manufacturing Drug License cover multiple factories?
A licence is associated with the approved manufacturing premises and activities. A business planning production at another factory should assess the need for separate licensing or other regulatory approval. A common company name does not automatically extend one facility's manufacturing permission to every location.
Can a manufacturer add new products to an existing licence?
Additional products may require product endorsement, permission or another prescribed regulatory process. The answer depends on the product category and existing licence scope. The manufacturer should confirm the applicable requirements before producing a product not already covered by its approvals.
Is WHO-GMP certification the same as a Drug Manufacturing License?
No. A statutory manufacturing licence and WHO-GMP-related certification or regulatory documentation serve different purposes. Applicable domestic GMP obligations must be met regardless of whether a business seeks additional certificates for exports or other commercial requirements. Export-market expectations should be assessed separately.
Can I apply for a Manufacturing Drug License without a consultant?
Yes. An eligible applicant may use the prescribed government application route directly. Private consultancy is optional. Technical preparation and regulatory compliance remain the applicant's responsibility, and the licensing authority independently assesses the application. Professional assistance does not guarantee approval.
