Drug Import Registration and Drug Import License in India: Form 41, Form 10, Fees and Process
Drug import license in India: Form 40 to Form 41 registration, Form 8 to Form 10 licence on SUGAM, fees, documents and Indian agent support.
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What Is Drug Import Registration?
Drug import registration is the CDSCO approval system that allows medicines and active pharmaceutical ingredients made outside India to be imported for sale. It has two parts. First, the overseas manufacturer's site and each drug are registered with CDSCO through a registration certificate on Form 41, applied for on Form 40. Second, the Indian importer obtains a drug import license on Form 10, applied for on Form 8, which allows it to import the registered drugs. Both are granted by the Drugs Controller General (India), the Central Licensing Authority, under Part IV of the Drugs Rules, 1945.
CDSCO drug import registration is the same for every state, and applications are filed online on ONDLS or your state drug licensing portal. What changes by location is the importer's own licence: the Indian agent or importer must already hold a wholesale drug licence (Form 20B and 21B) or a drug manufacturing licence from its State Licensing Authority, which in India is the State Drug Licensing Authority. So a drug import license India business needs both a central approval and a state licence before the first consignment lands.
The two approvals at a glance
| Point | Registration certificate | Import licence |
|---|---|---|
| What it covers | The overseas manufacturing site and each drug made there | The Indian importer's right to import the registered drugs |
| Application form | Form 40 | Form 8 (Form 8A for Schedule X), with the Form 9 undertaking |
| Certificate | Form 41 registration certificate | Form 10 import licence (Form 10A for Schedule X) |
| Applicant | Overseas manufacturer, through its Indian authorised agent | The Indian importer or authorised agent |
| Government fee | USD 10,000 per site plus USD 5,000 per drug | ā¹10,000 for the first drug plus ā¹1,000 per additional drug |
| Decision time | Within 9 months of a complete application, extendable by 3 months | Shortly after, once the Form 41 is in place |
| Validity | Three years; re-register 9 months before expiry | Generally three years, and never beyond the Form 41 |
Who Needs an Import License for Drugs in India?
An import license for drugs in India is needed by anyone who brings in drugs for sale or distribution, including:
- Indian distributors and importers of finished formulations made abroad: tablets, capsules, injections, inhalers, ointments and other dosage forms
- Overseas pharmaceutical companies entering India through a subsidiary or an authorised agent
- Indian manufacturers importing APIs (bulk drugs), excipients classed as drugs, or intermediates that are drugs, for use in their own production
- Hospital supply companies importing speciality medicines not made in India
- Pharma start-ups building an import-led medicine business before investing in manufacturing
Imports that are not for sale follow other routes: small quantities for examination, test or analysis need a test licence (Form 11, applied for on Form 12), and new drugs not yet approved in India need permission under the New Drugs and Clinical Trials Rules, 2019 before any registration. See our Drug Test License page for test imports.
Registration Certificate, Import Licence or Test Licence: Which Do You Need?
The three approvals are often confused, and applying for the wrong one wastes months. This table shows which route fits which purpose:
| Purpose | Approval | Forms | Who holds it |
|---|---|---|---|
| Register an overseas site and its drugs for the Indian market | Registration certificate | Form 40 to Form 41 | Overseas manufacturer, through its Indian agent |
| Import registered drugs for sale | Import licence | Form 8 (with Form 9) to Form 10; Form 8A to Form 10A for Schedule X | Indian importer or agent with a wholesale or manufacturing licence |
| Import small quantities for examination, test or analysis | Test licence | Form 12 to Form 11 | Indian company or institution doing the testing |
| Import a drug never approved in India | New drug permission first, then registration | New Drugs and Clinical Trials Rules, 2019 | Applicant for marketing permission |
In practice, a commercial import license for drugs in India always means both the Form 41 and the form 10 import license. A company that only holds a Form 10 for another manufacturer's site cannot import products from a different site, and a Form 41 on its own does not allow anyone to import. CDSCO drug import registration is therefore planned as a pair: the manufacturer's registration and the importer's licence, filed one after the other on SUGAM.
Drug imports for hospitals and speciality medicines
Hospitals and speciality distributors often need medicines that are not made in India, such as orphan drugs, newer biologics or specific strengths. Where the drug is already approved in India, the usual Form 41 and Form 10 route applies and the importer supplies the hospital through its wholesale licence. Where it is not approved, the new drug permission comes first, and some special-access routes for unapproved drugs exist for individual patients under strict conditions. Hospital buyers usually ask suppliers for copies of the Form 41, the form 10 import license and the wholesale licence before placing an order, so keep a ready set for each product.
Form 41 Registration Certificate: Foreign Manufacturer Registration with CDSCO
The Form 41 registration certificate is the first and longest step. It registers the overseas manufacturing premises and every drug made there that will be imported into India, and it is the basis on which any importer can later obtain a Form 10 import licence. This foreign manufacturer registration CDSCO grants is product-specific and site-specific: a drug made at two different sites needs both sites registered, and a new drug from a registered site needs an endorsement before it can be imported.
The registration certificate drugs CDSCO issues lists the manufacturer's name and address, the site, and the approved drugs with their strengths and dosage forms. Customs, the CDSCO port office, distributors and hospital buyers all read that list, so the names in it must match the labels, invoices and import licence exactly.
Form 40 CDSCO application: what goes in it
The Form 40 CDSCO application is made by the overseas manufacturer through its Indian authorised agent, or by the manufacturer itself where it has an Indian presence that holds the required licence. It is filed on SUGAM with the fee and a structured dossier that follows Schedule D(I) for the manufacturer's administrative information and Schedule D(II) for the drug's technical information. CDSCO must issue the Form 41 within nine months of receiving a complete application; in exceptional cases, with reasons recorded, it can extend this by three months. Inspection of the overseas site is not required before grant in every case, but CDSCO can decide to inspect, and an inspection fee then applies.
New drugs must be approved first
If the drug is a new drug in India, meaning it has not been approved here before or is a new combination, strength or route, CDSCO permission under the New Drugs and Clinical Trials Rules, 2019 must come before the Form 40 application. A Form 41 cannot be granted for a new drug that has no marketing permission in India. New drugs also carry post-approval duties, such as Periodic Safety Update Reports.
Authorized Agent India CDSCO Drugs: Role and Requirements
Most overseas manufacturers work through an authorized agent India CDSCO drugs rules recognise. The agent is the manufacturer's legal representative in India: it files Form 40, holds the Form 41 registration certificate, answers CDSCO's queries, reports changes and is responsible, together with the manufacturer, for the drugs it imports.
The agent must hold a valid wholesale drug licence (Form 20B and 21B) or a drug manufacturing licence issued by a State Licensing Authority. The appointment is made by a power of attorney that:
- is executed and authenticated before a first-class magistrate in India, or before an equivalent authority abroad and attested by the Indian embassy, or apostilled in a Hague Convention country
- is signed by both the manufacturer and the Indian agent
- lists the drugs, their indications and the manufacturing sites, matching Form 40 exactly
- remains valid for the period of the registration certificate, with a fresh power of attorney at re-registration
Where a drug is made by a toll or contract manufacturer, the power of attorney is signed by the marketing authorisation holder, with the manufacturing agreement as proof. Choosing the agent is a long-term decision, because the Form 41 sits with the agent; changing agents later needs fresh documents and an amendment.
Authenticating documents from different countries
Most overseas documents in a drug import file, including the power of attorney, the free sale certificate, the COPP and the Form 9 undertaking, must be authenticated. Manufacturers in countries that belong to the Hague Apostille Convention, such as the USA, the UK, EU member states, Japan, South Korea and, since November 2023, China, can apostille their documents. Manufacturers in other countries need attestation by the Indian embassy or consulate. Check the route for your manufacturer's country at the start, because authentication can add several weeks if documents are sent back and forth. Keep the originals safe: CDSCO can ask to see them, and a fresh set will be needed at re-registration.
Drug Import Registration Documents
The drug import registration documents for a Form 40 application usually include:
- Covering letter with an index, stating whether the application is new or adds drugs to an existing certificate
- Form 40, signed by the authorised agent
- Fee payment receipt
- Authenticated power of attorney
- Copy of the agent's wholesale or manufacturing licence
- Schedule D(I) information on the manufacturer and site
- Schedule D(II) technical information on each drug
- Plant Master File (site master file), notarised
- Drug Master File for each drug, notarised; an EU or US approved DMF number can be cited
- Free sale certificate from the country of origin
- Certificate of Pharmaceutical Product (COPP) or WHO-GMP certificate
- Marketing authorisation or manufacturing licence from the country of origin
- Recent inspection or audit report of the site
- Undertaking for re-registration
For the Form 8 import licence, the importer adds the Form 9 undertaking, a copy of the valid Form 41 authenticated by the agent, and its own wholesale or manufacturing licence. The names of drugs and sites must match the Form 41 word for word. Mismatched names across these documents are the most common cause of queries and delay.
Form 10 Import License: The Importer's Approval
Once the drug is registered on Form 41, the Indian importer applies for the form 10 import license. It names the importer, the manufacturer, the site and the drugs that may be imported, and it is checked against every consignment at the port.
Form 8 import license application
The form 8 import license application is filed on SUGAM by the importer or authorised agent for drugs other than those in Schedule X. It is accompanied by the Form 9 undertaking, an authenticated copy of the valid Form 41, the importer's wholesale or manufacturing licence, and the fee. CDSCO's published FAQ indicates that a complete Form 8 application is decided within about 45 days.
Form 9 import license undertaking
The form 9 import license undertaking is a declaration by or on behalf of the manufacturer that it will comply with Indian standards and conditions of import: that the drugs meet the prescribed standards, that the manufacturer will allow inspection of its site if required, and that it will supply samples and information when asked. The undertaking must be notarised, and where it is signed by the manufacturer abroad, authenticated by the Indian embassy or apostilled.
Form 10A import license for Schedule X drugs
Schedule X drugs, mostly psychotropic substances with high abuse potential, follow a stricter route. The application is made on Form 8A and the licence is granted on Form 10A. A form 10A import license schedule X holder must also meet the storage, record-keeping and narcotics-law requirements that apply to these drugs. Plan Schedule X imports separately from the rest of your range, as they take longer and are inspected more closely.
API Import License India: Import of Bulk Drugs India CDSCO
There is no separate API import license India uses for bulk drugs; active pharmaceutical ingredients follow the same Form 41 registration and Form 10 import licence route as finished formulations. The import of bulk drugs India CDSCO allows has a few extra technical requirements:
- Samples from three consecutive batches are sent to a CDSCO-designated laboratory for testing, with adequate retention samples
- The dossier includes specifications, analytical methods, in-house certificates of analysis, impurity standards and reference standards with their certificates
- Batch test reports for five consecutive production batches from each manufacturing site
- Standards follow the Indian Pharmacopoeia first, and otherwise the USP, BP or EP
Most API importers are Indian manufacturers that hold a Form 25 or Form 28 manufacturing licence, which also meets the eligibility requirement for the import licence. Where an API is imported by a trader for resale to manufacturers, the trader needs a wholesale drug licence.
How to Import Medicines into India: Step by Step
If you are working out how to import medicines into India for the first time, the process runs in this order:
- Confirm the drug's status. Check whether it is already approved in India, a new drug needing permission first, or a Schedule X drug.
- Set up the importer. Obtain or confirm the wholesale drug licence (Form 20B and 21B) or manufacturing licence, the Importer Exporter Code and GST registration.
- Appoint the authorised agent by an authenticated power of attorney.
- Collect the manufacturer's documents: Plant Master File, Drug Master Files, free sale certificate, COPP or WHO-GMP certificate, and site licences.
- File Form 40 on SUGAM with the registration fee.
- Answer queries and, if required, support an overseas inspection.
- Receive the Form 41 registration certificate.
- File Form 8 with the Form 9 undertaking and the import licence fee.
- Receive the Form 10 import licence and plan the first consignment through a notified port.
SUGAM drug import filing
SUGAM drug import filing covers both Form 40 and Form 8. The applicant registers on SUGAM, CDSCO's online portal, with company documents and an authorised signatory, then uploads each application as structured sections with PDF attachments. Fees are paid online and the receipt attached. Queries, deficiency letters and the final certificates are issued through the same dashboard, so the account must be checked daily while an application is pending.
A typical drug import registration timeline
| Stage | Typical time |
|---|---|
| Drug status check, agent appointment and power of attorney | 2ā4 weeks |
| Wholesale drug licence, if not already held | 1ā2 months, in parallel |
| Collecting and authenticating the manufacturer's documents | 4ā8 weeks |
| Form 40 review by CDSCO, including queries | Up to 9 months under the rules, extendable by 3 |
| Form 8 review and grant of Form 10 | About 45 days after a complete application |
| First consignment and port clearance | 2ā4 weeks, depending on shipping |
The longest and least predictable step is the Form 40 review. The best way to shorten it is a dossier in which every name, strength and address matches across Form 40, the power of attorney, the COPP, the Drug Master File and the labels.
Drug Import Registration Fees
The drug import registration fees are set in the Drugs Rules, 1945:
| Item | Government fee |
|---|---|
| Form 41 registration: each manufacturing site | USD 10,000 |
| Form 41 registration: each drug | USD 5,000 |
| Additional site for testing, primary packaging or batch release | USD 10,000 |
| Adding a drug to an existing registration | USD 5,000 per drug |
| Overseas inspection, if CDSCO decides to inspect | Set in the rules; CDSCO's FAQ quotes USD 25,000 |
| Form 10 import licence | ā¹10,000 for the first drug, ā¹1,000 for each additional drug |
Post-approval changes to a registration also carry fees, depending on whether the change is major or minor. A manufacturer registering one site and four drugs therefore pays USD 10,000 plus 4 Ć USD 5,000, or USD 30,000, for the registration, and the importer pays ā¹13,000 for a Form 10 covering the same four drugs. Confirm current amounts on SUGAM before paying; Regovex gives every client a written estimate first.
Form 41 Validity CDSCO and Re-Registration
The form 41 validity CDSCO applies is three years from the date of issue, unless the certificate is suspended or cancelled earlier. The Form 10 import licence is generally valid for three years as well, but never beyond the validity of the Form 41 on which it is based.
To keep importing without a gap, apply for the re registration certificate CDSCO form 41 at least nine months before the current certificate expires. Re-registration needs the same documents as a fresh application, including a fresh power of attorney, and any post-approval changes should be approved before re-registration so that they appear on the new certificate. Apply to renew the Form 10 at least three months before it expires, with details of the drugs imported in the previous period. Regovex tracks both dates for every client.
Post-Approval Changes to a Registration Certificate
A registration certificate drugs CDSCO issues reflects the site and product as they were when the dossier was approved. Changes after approval must be reported, and many must be approved before the changed product is imported. Typical examples are:
- Major changes, such as a change in the manufacturing process, the manufacturing site for a step, the specifications, the shelf life or the primary packaging
- Administrative changes, such as a change in the manufacturer's name or address without a change in the actual site, or a change of authorised agent
- Minor changes that do not affect quality, which are usually notified rather than approved
Post-approval change applications carry their own fees, with major changes costing more than administrative ones. Approve changes before re-registration so that the new Form 41 shows the product as it is actually made; otherwise the change will not appear on the renewed certificate, and imports of the changed product can be stopped at the port.
Starting a Medicine Import Business in India
A medicine import business India can be profitable, especially for speciality medicines, but the approvals decide when you can start trading. Plan these pieces together:
| What you need | Issued by | Why it matters |
|---|---|---|
| Company or firm with GST registration | Registrar and GST department | Every licence is issued in this name |
| Importer Exporter Code (IEC) | DGFT | Needed for customs clearance |
| Wholesale drug licence (Form 20B and 21B) | the State Drug Licensing Authority | Required before CDSCO will accept you as agent or importer |
| Warehouse with proper storage and a competent person | Your own premises | Checked at the wholesale licence inspection |
| Form 41 registration certificate for each site and drug | CDSCO | Registers the overseas manufacturer and products |
| Form 10 import licence | CDSCO | Allows you to import the registered drugs |
| Supply agreement and power of attorney with the manufacturer | Commercial | Sets who holds the registration and for how long |
The usual order is: company and GST, IEC, warehouse and wholesale drug licence, then Form 40 and Form 8. Because the Form 41 can take up to nine months, many importers sign the supply agreement and start the registration while the warehouse licence is being processed. Build the timeline into your business plan: revenue starts only after the Form 10 is granted and the first consignment clears. Our Wholesale Pharmacy License page covers the state licence step.
Price control and labelling for imported drugs
Imported formulations that contain drugs under price control follow the same ceiling prices as Indian-made products, so check the pricing before you finalise the business case. Labels must carry the particulars required by the Drugs Rules, including the name and address of the manufacturer, the importer's name and address and the import licence number, and they must match the registration. Many importers add an India sticker before release from the bonded warehouse; keep the sticker text approved and consistent across consignments.
Choosing the manufacturer and products for your import portfolio
The success of a medicine import business India depends as much on the manufacturer as on the approvals. Before you sign a supply agreement, check that the manufacturer can supply a COPP or WHO-GMP certificate, a current free sale certificate and a complete Drug Master File for each product, and that its site has a clean inspection record with its own regulator. Confirm that the products meet Indian Pharmacopoeia standards or will be tested to them, and that pack sizes and labels can be adapted for India. Finally, check whether each product is already approved in India; an approved product can move straight to Form 40, while a new drug needs permission first and takes much longer. These checks also decide the drug import registration documents you will need, so doing them early saves rework later.
Port Clearance for Imported Drugs
Registered drugs can be imported only through ports where CDSCO has a port office. At clearance, the port officer checks the consignment against the Form 10 and Form 41, the labels, the batch documents and the shelf life remaining. The rules require imported drugs to have a substantial part of their shelf life left at the time of import, so plan shipments well ahead of expiry. The officer may draw samples for testing, and the consignment can be held until the report arrives. Typical reasons for port delays are drug names or strengths that differ from the licence, a site not on the Form 41, missing certificates of analysis and labels without the import licence number.
Staying Compliant After Approval
- Import only what is licensed. Every drug, strength and site must be on the Form 41 and Form 10.
- Keep import and sale records with batch numbers, so any batch can be traced and recalled.
- Report changes in the manufacturer, site, process, specifications or authorised agent, and get major changes approved before re-registration.
- Pharmacovigilance. Record and report adverse events, and submit Periodic Safety Update Reports for new drugs on time.
- Track validity. Re-register the Form 41 nine months before expiry and renew the Form 10 three months before expiry.
- Keep the wholesale licence current, including its retention fee, because the import licence depends on it.
Common Mistakes in Drug Import Registration
- Applying for a Form 10 before the Form 41 is granted, or for drugs not on the Form 41
- An Indian agent without a valid wholesale or manufacturing licence
- A power of attorney that does not list every drug and site, or is not properly authenticated
- Drug names, strengths and site addresses that differ between Form 40, the power of attorney, the COPP and the labels
- Treating a new drug as an ordinary registration and skipping the New Drugs and Clinical Trials Rules permission
- Filing API registrations without arranging the three-batch samples for testing
- Missing the nine-month re-registration window and creating a gap in imports
Checklist Before You File Form 40
- Each drug's status in India confirmed: approved, new drug, or Schedule X
- Indian agent holding a valid wholesale or manufacturing licence
- Power of attorney listing every drug and site, signed by both parties and authenticated
- Plant Master File and Drug Master Files notarised and consistent with each other
- Free sale certificate and COPP or WHO-GMP certificate current and matching the product names
- Schedule D(I) and D(II) information complete for each drug
- For APIs, three-batch samples and five-batch test reports arranged
- Labels drafted with Indian particulars and the importer's details
- Fees calculated per site and per drug, and paid
- SUGAM account active with an authorised signatory
Working through these drug import registration documents before filing is the most reliable way to keep the Form 41 review within the nine-month period.
How Regovex Handles Your Drug Import Registration in India
- Free eligibility check. We confirm each drug's status in India, whether it is a new drug or a Schedule X drug, and whether your company already holds the licence needed to act as agent or importer.
- Licence set-up. If you do not yet have a wholesale drug licence, we file it with the State Drug Licensing Authority in parallel.
- Power of attorney and document list for your overseas manufacturer, with the authentication route for its country.
- Dossier review. Plant Master File, Drug Master Files, COPP, free sale certificate and labels checked against each other and against Form 40.
- Form 40 filing on ONDLS or your state drug licensing portal, fee payment and query replies within 24ā48 hours.
- Form 8 and Form 9 filed as soon as the Form 41 is granted.
- First consignment support, label checks, and a compliance calendar for re-registration and renewals.
Why Importers Choose Regovex as Their CDSCO Registration Consultant
- Central and state licences together. As a drug license consultant and CDSCO registration consultant, we handle the wholesale licence, the Form 41 and the Form 10 as one project.
- Technical dossier experience with Plant Master Files, Drug Master Files and API batch-testing requirements.
- State FDA approval experience across Delhi NCR and Uttar Pradesh for the importer's warehouse licence.
- Clear 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.
- One point of contact from the first call to re-registration three years later.
Drug Import Registration Services in India and Nearby Areas
Regovex files drug import registrations and import licences for importers, distributors, overseas manufacturers and pharma start-ups in India. Documents are collected digitally from you and your manufacturer, and applications are filed on ONDLS or your state drug licensing portal. Our office is in Aligarh, and we work with clients across Delhi NCR, Uttar Pradesh and the rest of India.
We also serve importers in .
Related services:
- CDSCO Registration in India
- Wholesale Drug License in India
- Drug Test License
- Cosmetic Import Registration
- Medical Device Import License
What Our Clients Say
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. ā Bilal Ahmed Khan, Founder, Medwell Pharma
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Drug Import Registration Consultant in India: Regovex Consulting
Regovex Consulting helps importers, distributors, overseas manufacturers and pharma start-ups complete drug import registration in India quickly and correctly. An import license for drugs in India has two parts. First, CDSCO registers the overseas manufacturing site and each drug on a Form 41 registration certificate, applied for on Form 40. Second, the Indian importer obtains a drug import license on Form 10, applied for on Form 8 with the Form 9 import license undertaking. Schedule X drugs use Form 8A and the form 10A import license schedule X route. All of this is filed through SUGAM drug import applications.
The registration certificate drugs CDSCO issues is the heart of the process. This foreign manufacturer registration CDSCO grants needs a Plant Master File, Drug Master Files, a free sale certificate, a COPP or WHO-GMP certificate and an authenticated power of attorney. The form 40 CDSCO application must be decided within nine months, extendable by three. The form 41 validity CDSCO sets is three years, so the re registration certificate CDSCO form 41 application should be filed at least nine months before expiry.
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