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CDSCO Manufacturer License

A CDSCO Manufacturer License authorises you to legally manufacture drugs, cosmetics, medical devices or other regulated products in India under...

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Key takeaways

A Manufacturer License is mandatory under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 for anyone manufacturing drugs, cosmetics or medical devices in India.
It is granted by the State Licensing Authority (SLA) or the Central Drugs Standard Control Organisation (CDSCO), depending on the product category.
Most applications are filed online through the CDSCO SUGAM portal or the National Single Window System (NSWS).
The manufacturing site must comply with Good Manufacturing Practices (GMP) under Schedule M / Schedule M-III.
A qualified technical staff and competent person must be in place before the license is granted.
The license is generally issued in Forms 25, 28, 25-D or MD-9, depending on the product.
Manufacturing without the correct license is a punishable offence under the Act.

Overview

What is a CDSCO Manufacturer License?

A CDSCO Manufacturer License is the statutory approval that allows a business to legally manufacture drugs, cosmetics, medical devices and related regulated products in India. It is issued under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, with the Central Drugs Standard Control Organisation (CDSCO) acting as the national regulatory authority.

Depending on the product, the license is granted either by the State Licensing Authority or by CDSCO itself. The licensing system exists to ensure that everything manufactured for the Indian market is safe, effective and produced under controlled, hygienic conditions. Holding the correct license lets you produce and supply legally, win institutional and export business, and build trust with regulators and buyers.

Products that need a manufacturer license

Allopathic and generic drug formulations
Ayurvedic, Siddha and Unani medicines
Cosmetics manufactured in India
Medical devices and in-vitro diagnostics
Disinfectants, sanitisers and antiseptics
Bulk drugs and active pharmaceutical ingredients

Applicability

Who needs a manufacturer license

The category of license, and whether the State or Central authority grants it, depends on what you make. The table below maps common manufacturers to the licence they typically require.

Who you are	Why you need it
Drug formulation units	Manufacturing tablets, capsules, syrups or injectables for sale in India.
Loan / third-party manufacturers	Producing on a loan-licence basis using another firm’s approved premises.
Cosmetic factories	Manufacturing skin care, hair care, make-up or fragrances domestically.
Medical device makers	Producing notified devices and in-vitro diagnostics regulated by CDSCO.

Granting authority	Typical scope
State Licensing Authority	Most drug and cosmetic manufacturing licences within the state.
CDSCO (Central)	Class C and D medical devices, new drugs and certain notified categories.
Joint approval	Products requiring both state premises approval and central product approval.
Loan licence	Manufacturers without their own premises using a licensed facility.

How it works

The application process, step by step

Applications are filed online through the CDSCO SUGAM portal or the National Single Window System. The exact form differs by product, but the workflow is broadly the same.

Drug & cosmetic manufacture

Prepare the site
Set up GMP-compliant premises under Schedule M and appoint qualified technical staff and a competent person.
Apply online
Register on SUGAM or NSWS and file the relevant form with the product list, layout and staff details.
Inspection
The Drug Inspector verifies the premises, equipment, quality-control lab and technical credentials.
Grant of licence
On a satisfactory report, the licence is issued and you may manufacture legally.

Medical device manufacture

Classify the device
Determine the risk class (A, B, C or D) under the Medical Devices Rules, 2017.
File the application
Submit Form MD-3 (Class A/B) or MD-7 (Class C/D) online with technical documentation.
Audit / assessment
A notified body audit or CDSCO assessment of the quality management system is carried out.
Grant of licence
Licence in Form MD-5 or MD-9 is issued, authorising manufacture of the device.

Paperwork

Documents required

Company incorporation or partnership documents
Identity and address proof of proprietors or directors
Premises ownership or lease deed and approved site/layout plan
List of plant, machinery and equipment
Qualification and appointment letters of technical staff
Details of the quality-control laboratory arrangement
Product list with formulations or device specifications
Duly filled application form with the prescribed fee challan

Lifecycle

Validity & renewal

Manufacturing licences are issued in perpetuity under current rules, subject to a retention fee.
A licence retention fee is payable every five years to keep the licence in force.
The licence remains valid only while GMP and conditions of licence are maintained.
It can be suspended or cancelled by the licensing authority for non-compliance.

Need a related approval? See our Cosmetic License service for domestic cosmetic manufacture.

Budgeting

Fees, timeline & cost factors

Government fees are set per form and product category, and vary by state and the scale of the unit. The typical components are:

Cost factor	Details
Government fee	Prescribed application fee per product category and licence form.
Inspection fee	Charge for the on-site inspection or notified body audit, where applicable.
Documentation and filing	Preparation of the dossier, site master file and submission.
Retention fee	Payable every five years to keep the licence in force.
Typical timeline	Commonly 30 to 90 working days, depending on category, inspection and document readiness.

Not sure which licence form applies?

Tell us what you intend to manufacture, and we will map the exact authority, form, documents and timeline for your products.

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Why it matters

Benefits of a manufacturer license

Legal protection

Manufacture and supply without the risk of seizure, penalties or shutdown.

Market access

Supply to hospitals, government tenders, distributors and e-commerce that demand a valid licence.

Export readiness

A CDSCO licence underpins the WHO-GMP and Free Sale Certificates needed to export.

Consumer confidence

Buyers trust products made under regulated, GMP-compliant conditions.

Stronger reputation

A licensed manufacturer signals quality and reliability to partners and regulators.

Investment ready

Valid licences are essential for funding, partnerships and contract-manufacturing deals.

Compliance

Why the licence is mandatory

In India, CDSCO and the State Licensing Authorities regulate manufacture under the Drugs and Cosmetics Act, 1940 and the rules made under it. Manufacturing regulated products without the correct licence is a punishable offence, regardless of whether you are a small unit or a large plant.

What non-compliance can cost you

Penalties and imprisonment under the Drugs and Cosmetics Act.
Seizure of stock and product recalls from the market.
Suspension or cancellation of the licence and closure of the unit.
Prosecution of the firm and the persons responsible.

Why Diligence Certifications

Your compliance partner

From premises planning to the grant of licence, we manage the entire CDSCO journey so your team can focus on production.

End-to-end handling

We map the correct authority and form, prepare the dossier and file on SUGAM or NSWS for you.

Inspection readiness

We help align your premises, GMP and technical staff so you are ready for the Drug Inspector.

Expert team

Specialists in pharma, cosmetic and medical-device licensing across multiple states.

Lifecycle support

Retention fees, endorsements, product additions and renewals handled on time.

Ready to start manufacturing?

Speak to our regulatory team and get a clear, fixed roadmap to your CDSCO Manufacturer License.

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FAQ

Frequently asked questions

What is a CDSCO Manufacturer License?

It is the statutory approval to legally manufacture drugs, cosmetics, medical devices or related products in India, issued under the Drugs and Cosmetics Act, 1940 and the rules made under it.

Who issues the manufacturer license in India?

It is granted by the State Licensing Authority for most drugs and cosmetics, and by CDSCO for higher-risk categories such as Class C and D medical devices and new drugs.

Where do I apply for the license?

Applications are filed online through the CDSCO SUGAM portal or the National Single Window System, where you upload documents and track the status of your application.

How long does it take to get the license?

It commonly takes 30 to 90 working days, depending on the product category, the inspection or audit, and how complete your documentation is.

How long is the manufacturer license valid?

Under current rules manufacturing licences are issued in perpetuity, subject to a licence retention fee payable every five years and continued compliance with the conditions of licence.

Do I need GMP compliance before applying?

Yes. The premises must meet Good Manufacturing Practices under Schedule M, and you must have qualified technical staff in place, as the Drug Inspector verifies these during inspection.

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Why Diligence

Why choose Diligence Certification?

For compliance and credibility, Diligence is much more than a checklist - we give you real confidence in your business. We examine your legal, financial and operational status, so you are not just certified, but trusted.

Stronger risk protection

Spot hidden legal, financial or operational risks early - fix problems before they become threats.

Earn stakeholder trust

From investors to customers, people want to work with businesses that play by the rules.

Stay legally aligned

Compliant not just on products but on labour, environmental and tax laws too.

Enhance brand reputation

Show the world you operate with integrity and transparency.

Stand out from competitors

In a crowded market, credibility is your biggest edge.

24×7 expert support

A 100+ strong service team guiding you at every step, free first consultation.

Real sites, real certifications

Our teams work inside factories and plants across India and abroad - inspections, audits and certification milestones spanning BIS, global schemes and the full compliance stack you see on this site.