Drug Test License in India: Form 29, CDSCO Test Licence, Fees and Process

What Is a Drug Test License?

A drug test license is a licence that allows a company or institution to make or import small quantities of a drug only for examination, test or analysis, not for sale. There are two main kinds. A Form 29 drug license is the state licence to manufacture drugs for examination, test or analysis, applied for on Form 30 under Rule 89 of the Drugs Rules, 1945. A CDSCO test license on Form 11 allows small quantities of drugs to be imported for the same purposes, applied for on Form 12 under Rules 33 and 34.

In plain words, a test license for drugs is what lets an R&D team make trial batches, a laboratory analyse a reference product, or a CRO run a bioequivalence study, without holding a full manufacturing or import licence for those products. The drugs made or imported under a test licence cannot be sold or supplied to anyone except for the stated testing purpose.

In India, Form 29 is granted by the State Drug Licensing Authority on an application filed on ONDLS or your state drug licensing portal. Import test licences are granted by CDSCO. New drugs that have not yet been approved in India need permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before they can be made or imported even for testing.

Who Needs a Test License for Drugs?

• Pharma R&D and formulation development teams making trial, pilot or stability batches before a product is on their manufacturing licence
• Contract research organisations (CROs) running bioequivalence and bioavailability studies
• Analytical laboratories testing reference products, impurities or methods
• Companies importing reference standards, innovator samples or APIs for testing and development
• Universities, pharmacy colleges and research institutions developing new formulations
• Start-ups and new manufacturers developing products before their plant is licensed

A test license for R&D drugs is often the first licence a pharma start-up holds. It lets the team prove the formula, run stability studies and generate data, while the plant and the full manufacturing licence are still being prepared.

Types of Drug Test License: Which One Do You Need?

The right drug test license depends on two questions: are you making the drug or importing it, and is the drug already approved in India or new? This table answers both:

Form 29 drug license: licence to manufacture for testing

The Form 29 drug license is the most common test licence. Under Rule 89 of the Drugs Rules, anyone who wants to make a drug for examination, test or analysis and does not hold a Form 25 or Form 28 licence for that drug must first get a Form 29 licence. People searching for a licence to manufacture drugs for examination test analysis are looking for this Form 29. It is granted by the State Licensing Authority, here the State Drug Licensing Authority, on an application in Form 30, and the government fee is ₹250.

The conditions are strict: the drugs may be used only for examination, test or analysis at the site named on the licence; inspectors may enter the premises with or without notice; and records must be kept of the quantities made and of everyone to whom any quantity is supplied.

Form 11 test license: importing drugs for testing

A Form 11 test license lets a company or institution import small quantities of drugs for examination, test or analysis. You file a Form 12 test license application with CDSCO under Rule 34, made or countersigned by the head of the testing institution or a director of the company. The fee is ₹100 for the first drug and ₹50 for each additional drug, whatever the strength, dosage form or pack size. Under Rule 33, the quantity of any single drug should not normally exceed 100 average doses per patient, although CDSCO can allow more where the testing plan justifies it.

Test license for import of drugs, APIs and reference products

A test license for import of drugs covers innovator samples, reference products for comparison, and finished formulations needed for analytical work. A test license for API import is used when a manufacturer or laboratory needs a small quantity of an active pharmaceutical ingredient for formulation development or analysis. CDSCO's guidance says it will not consider test licence applications for banned drugs, starting materials, excipients, or herbal and agricultural products, so check the product's status before applying.

Test license for bioequivalence study

A test license for bioequivalence study is needed when a CRO or sponsor imports the reference product for a BE study. For approved drugs, the import is usually under Form 11, with the BE protocol and quantity justification. For new drugs, including modified-release forms that CDSCO treats as new, the study also needs CDSCO approval and the import is made under a CT-17 licence.

CT-16 CT-17 test licence for new drugs

Under the New Drugs and Clinical Trials Rules, 2019, a new or investigational drug imported for a clinical trial, BA/BE study or examination, test and analysis needs a licence on Form CT-17, applied for on Form CT-16. The applicant usually holds a wholesale drug licence, and the CT-17 is valid for three years. Searches for a CT-16 CT-17 test licence refer to this route. Making a new drug in India for the same purposes needs CDSCO permission on Form CT-11, applied for on Form CT-10, before any Form 29 can be used.

Test License vs Manufacturing License

A test license vs manufacturing license comparison comes down to purpose and quantity:

Most companies use both in sequence: a test licence while the product is developed and stability data is generated, then the product is added to the manufacturing licence before commercial batches. See our drug manufacturing license page for the next step.

Test Licences for Medical Devices, Cosmetics and AYUSH Products

The Form 29 and Form 11 test licences are for drugs. Other products have their own routes:

If your project mixes product types, for example a drug-device combination, each part may need its own permission. See our medical device manufacturing license page for MD-13.

How to Write a Quantity Justification That Gets Approved

The most common query on a test licence asks why you need the quantity you applied for. A good justification answers before the question is asked:

• List each test you will run (assay, dissolution, impurities, stability, method development) with the quantity per test
• State the number of batches and the batch size for development or stability work, with the stability conditions and time points
• For BE studies, give the number of subjects, doses per subject and retention samples required
• Add a reasonable margin for repeats, and say so
• Refer to the monograph or guideline your tests follow
• Sign and date the statement by the authorised signatory

CDSCO's guidance notes that there is no fixed definition of a "small quantity", so a clear calculation is what decides approval. Regovex writes this statement with your R&D team before filing.

Who Uses Drug Test Licences, and How

Pharma start-ups

A start-up developing its first products often holds a Form 29 for a small laboratory or pilot plant, generates formulation and stability data, and then partners with a licensed manufacturer or builds its own plant. The test licence keeps development legal from day one.

Contract research organisations

CROs import reference products for BE studies under Form 11, or under CT-17 for new drugs, and must keep strict records of receipt, dosing, retention samples and destruction. Their sponsors should check that the CRO's licences match the study.

Established manufacturers

Licensed manufacturers developing new products usually make development batches under their existing manufacturing licence or a Form 29 for the new product, and import innovator samples on Form 11 for comparison testing.

Universities and research institutes

Academic laboratories that make drug formulations for research need a Form 29 for their laboratory, signed by the head of the institution, and must not supply the material outside the approved research.

A Typical Drug Test Licence Timeline

New-drug routes take longer, because the trial or study approval comes first. We share a dated plan with your team at the start, so R&D schedules can be set around it.

Eligibility for a Drug Test License

To get a Form 29 drug test license, you need:

1. A suitable site: a laboratory, pilot plant or R&D facility with the equipment needed to make and test the product safely, at an address you lawfully occupy
2. Qualified staff: a person competent to supervise the manufacture and testing, usually with a pharmacy or chemistry qualification and relevant experience
3. A clear purpose and quantity: a testing or development plan that justifies the amount you will make
4. The drug's status: an approved drug, or CDSCO permission (CT-11) if it is a new drug
5. Records: a system to record quantities made, used, supplied and destroyed

Already hold a Form 25 or Form 28 licence?

Rule 89 requires a Form 29 only where the manufacturer does not hold a Form 25 or Form 28 licence for that drug. If your plant is already licensed to manufacture the product, it can usually be made for testing under that licence. A 2019 recommendation of the Drugs Technical Advisory Board proposed going further, so that licensed units could make approved drugs in the same dosage form for testing by uploading details on SUGAM. Before relying on this, we confirm the current position with the State Drug Licensing Authority.

Drug Test License Documents Required

The drug test license documents required depend on the route. These are the usual files:

For a Form 29 (manufacture for test)

• Form 30, signed by the head of the institution or a director or partner of the firm
• Covering letter stating the purpose and the list of enclosures
• Fee challan or online payment receipt for ₹250
• Constitution of the firm: certificate of incorporation, partnership deed or registration of the institution
• Proof of possession of the premises: ownership documents or rent agreement
• Layout plan of the laboratory or pilot plant
• List of equipment and testing instruments
• Qualification, experience and appointment letter of the technical person
• List of drugs, with dosage forms, strengths and the quantity to be made, with a justification
• CDSCO permission on CT-11 for new drugs
• Copy of any existing Form 25 or Form 28 licence

For a Form 11 (import for test)

CDSCO's test licence guidance lists:

• Covering letter and Form 12
• Fee challan (₹100 for the first product and ₹50 for each additional product)
• Form 29 for new drugs, or Form 25 with manufacturing permission for an approved bulk API; the testing site address must match Form 12
• Utilisation and justification: test parameters, quantity per test and, for BE studies, the break-up
• Notarised undertaking justifying any large quantity
• BE protocol and, for new drugs, the BE approval
• Notarised agreement if the testing is done at another firm's facility
• Valid DSIR recognition certificate for in-house R&D units, where applicable
• Authority letter and ID proof for the person collecting letters

For a CT-17 (import of new drug)

Form CT-16 with details of the drug, the trial or study approval, the quantity and the applicant's wholesale licence, plus the fee and supporting documents set out in the NDCT Rules.

How to Get Test License for Drugs: Step by Step

Here is how to get test license for drugs in India, from the first check to the licence in hand.

Form 30 drug license application for Form 29

1. Confirm the route. Decide whether you need Form 29 (making), Form 11 (importing) or a CDSCO new-drug permission first.
2. Check the drug's status. For a new drug, get CDSCO permission on CT-11 before applying for Form 29.
3. Prepare the site and staff. Make sure the laboratory or pilot plant, equipment and technical person are in place.
4. Write the testing plan. List each drug, dosage form, strength and quantity, with the reason for the quantity.
5. Prepare the Form 30 drug license application with the documents listed above.
6. File on ONDLS or your state drug licensing portal and pay the ₹250 fee.
7. Answer queries and allow inspection. the State Drug Licensing Authority may inspect the site before granting the licence.
8. Receive the Form 29 licence, which names the site, the drugs and the purpose.

Form 12 test license application to CDSCO

For imports, the Form 12 test license application is filed with CDSCO with the fee, the testing justification and, where relevant, the BE protocol. CDSCO may raise queries; each reply should be filed separately per application with the original reference number. Once the Form 11 is granted, the consignment can be cleared at the port against it.

Timeline

With a complete file, a Form 29 is usually granted within a few weeks, depending on whether the State Drug Licensing Authority inspects the site first. Form 11 import test licences usually take several weeks at CDSCO, longer if queries are raised. New-drug permissions (CT-11) and CT-17 import licences follow the timelines in the NDCT Rules and take longer because the study or trial approval comes first.

Drug Test License Fees

The drug test license fees are set by the rules and are among the lowest in drug licensing:

The real cost of a test licence is usually the time lost when an application is returned. Our professional fee is quoted in writing, with government fees shown separately.

Form 29 Test License Validity and Renewal

A Form 29 test licence is granted for a fixed period from the date of issue and can then be renewed. On Form 29 test license validity, current summaries of Rule 89 cite three years from the date of issue, with renewal after that, while older CDSCO guidance refers to one year at a time. The exact expiry date is printed on your licence, so diarise it the day the licence arrives.

Test license renewal for drugs

R&D teams often search for "test license renewal drugs" rules; the answer differs by route:

• Form 29: apply to the State Drug Licensing Authority for renewal before expiry, with an updated list of drugs and quantities and the fee. Testing must stop if the licence lapses.
• Form 11: CDSCO does not renew Form 11 licences; a fresh Form 12 application with the full documents and fee is filed for each new requirement.
• CT-17: valid for three years; CDSCO may extend it by one year only in exceptional circumstances.

Regovex tracks expiry dates for all your test licences and files renewals or fresh applications in time, so your development programme is never held up by an expired licence.

What to prepare for a Form 29 renewal

A test license renewal drugs application is simpler than the first one, but it still needs care: an updated list of drugs and quantities, a summary of what was made and used under the current licence, confirmation that the site and technical person are unchanged (or details of the change), the fee, and the stock and destruction records. File it well before expiry, because testing must stop on the day the licence lapses.

After the Test Licence: Conditions and Records

A drug test license comes with conditions that inspectors check. Breaking them can lead to cancellation, and under Rule 35 a licensee whose import test licence is cancelled may appeal to the Central Government within three months.

Use only for testing

Drugs made or imported under a test licence may be used only for examination, test or analysis, at the site named on the licence. They must not be sold, given as samples to doctors or used in patients outside an approved trial or study.

Records to keep

• Quantities made or imported, with dates, batch numbers and the source
• Quantities used in each test or study, with the test or protocol reference
• Any quantity supplied to another laboratory, with the recipient's name and authorisation
• Quantities destroyed, with the date, method and witnesses
• Storage conditions and stock reconciliation

Imported test drugs must be stored properly and dispensed under the supervision of a registered pharmacist where the rules require it.

Labelling and storage

Label test batches clearly as made for examination, test or analysis only, with the batch number and date. Keep test material separate from commercial stock, so there is no risk of mix-up in a plant that also holds a manufacturing licence.

Disposal of leftover material

Leftover, expired, damaged or substandard test material must be destroyed and the destruction recorded. For CT-17 imports, the NDCT Rules require unused or expired drugs to be destroyed with records kept.

Moving from test licence to manufacturing licence

When development is complete, the product must be added to your Form 25 or Form 28 manufacturing licence before any commercial batch is made. Stability data from the test batches supports the shelf life you claim. For new drugs, CDSCO marketing permission is needed first.

Common Mistakes in Drug Test Licence Applications

• Using Form 29 for a new drug without CDSCO permission on CT-11 first
• Asking for more quantity than the plan justifies, especially for Form 11 imports, which normally allow about 100 average doses per patient
• Applying for a Form 11 for excipients or starting materials, which CDSCO does not consider
• A testing site address that differs between Form 12 and the supporting licence
• Letting Form 29 expire while studies are still running
• Selling or supplying test batches, which turns a test licence breach into an offence

Checklist Before You Apply for a Drug Test Licence

• Route confirmed: Form 29, Form 11, CT-11 or CT-17
• Drug status checked: approved in India, or new and needing CDSCO permission
• Testing site ready, with lawful possession and a layout plan
• Technical person appointed, with qualification and appointment letter
• Testing plan written for each drug, with quantities and a margin for repeats
• Constitution documents and authorised signatory confirmed
• For imports: supplier details, port of entry and storage arrangements
• For BE studies: protocol, ethics approval and study approval where needed
• Record formats ready for receipt, use, supply and destruction
• Expiry date to be diarised the day the licence is granted

How to Choose a Test License Consultant in India

A good test license consultant in India saves your R&D team weeks of back-and-forth. Before choosing one, ask:

1. Can you handle all three routes: state Form 29, CDSCO Form 11 and new-drug permissions under the NDCT Rules?
2. Will you check whether the drug is new and needs CDSCO permission before Form 29?
3. Who writes the quantity justification and the utilisation statement?
4. Do you track expiry dates and file renewals or fresh Form 12 applications in time?
5. Can you take the product through to a manufacturing licence when development is complete?

Why R&D Teams in India Choose Regovex for Their Drug Test License

• The right route first: state test licence, CDSCO import test licence or new-drug permission, decided before any document is drafted
• Quantity justifications that hold up, based on test parameters, batch sizes and study designs
• Complete Form 30 and Form 12 files, with the site, staff and testing plan consistent across every document
• Query replies within 24–48 hours at the state authority and CDSCO
• Expiry and renewal tracking for every test licence you hold
• A path to commercial manufacture, with product additions to Form 25 or 28 and Schedule M readiness
• Transparent 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

As a test license consultant India-wide, and a drug license consultant, CDSCO registration consultant and drug regulatory consultant in India, Regovex handles your test licences alongside your manufacturing, import and wholesale licences.

Drug Test License Services in India and Nearby Areas

Regovex helps pharma R&D centres, formulation start-ups, CROs, analytical laboratories and research institutions in India. Form 30 applications are filed on ONDLS or your state drug licensing portal and decided by the State Drug Licensing Authority; import test licences and new-drug permissions are filed with CDSCO. Documents are collected digitally.

We also serve businesses in .

Related services:

• Drug Manufacturing License in India
• Drug License in India
• CDSCO Registration in India
• Wholesale Drug License in India
• Medical Device Manufacturing 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

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