Circular No. 40/2026-Customs: Mandatory Compliance Checklists for Cosmetics, Drugs and Medical Devices Before Out-of-Charge.

Introduction

The Central Board of Indirect Taxes and Customs (CBIC), Ministry of Finance, has issued Circular No. 40/2026-Customs dated 3 September 2026, prescribing detailed checklists for verification by Customs officers before granting Out-of-Charge (OOC) in respect of facilitated Bills of Entry involving Cosmetics, Drugs and Medical Devices. The Circular has been issued in the context of the Government's continuing efforts to promote the Ease of Doing Business, while ensuring that mandatory regulatory requirements applicable to these sensitive products are complied with.

The initiative has been undertaken in coordination with the Central Drugs Standard Control Organisation (CDSCO). Since integration of the relevant regulatory documents under SWIFT 2.0 is still under process, the CBIC has directed field formations to exercise due diligence and verify the prescribed documents before allowing clearance. The Circular therefore seeks to strike a balance between trade facilitation and regulatory compliance.

Why has the Circular been issued?

Cosmetics, drugs and medical devices are subject to several mandatory requirements under the Drugs and Cosmetics Act, 1940 and the Rules made thereunder. Depending upon the nature and purpose of the import, an importer may be required to possess licences, permissions, registration certificates and other supporting documents. In the case of facilitated Bills of Entry, Customs may ordinarily rely on the facilitation mechanism. However, the CBIC has recognised that the regulatory-document integration under SWIFT 2.0 is presently under development.

Consequently, until the electronic integration is fully operational, Customs officers have been instructed to verify the prescribed documentation before granting OOC. The Circular is particularly important because it makes clear that facilitation of a Bill of Entry does not dispense with mandatory regulatory compliance applicable to these categories of goods.

Seven categories covered by the checklists

The CDSCO has provided seven separate checklists, covering different categories of imports:

1. Cosmetics
2. Drugs, including APIs (Active Pharmaceutical Ingredients) and finished formulations
3. Drugs imported for personal use or in small quantities by Government Hospitals/Autonomous Medical Institutions
4. Drugs imported for examination, test or analysis
5. Medical Devices, including IVDs (In Vitro Diagnostic kits/devices)
6. Medical Devices imported for clinical investigations, testing, evaluation, demonstration, training, treatment or personal use
7. Raw materials/components used in the manufacture of Medical Devices

These checklists are intended to provide a standardised verification framework for Customs officers.

Checklist I - Import of Cosmetics

For imports of cosmetics, Customs officers are required to verify a number of documents and particulars before OOC.

Registration Certificate

The importer is required to submit a self-certified copy of the Registration Certificate (RC):

• Form COS-2 in case of fresh registration; or
• Form COS-4A in case of subsequent registration,

as issued by CDSCO.

In the case of new cosmetics proposed to be imported under Form COS-3, the consignment is required to be referred to the concerned CDSCO port office.

Commercial documents

The following documents are required:

• Self-certified copy of the invoice;
• Self-certified copy of the packing list; and
• Self-certified copy of the certificate of country of origin.

The invoice should mention the name of the cosmetic and should correspond with the Registration Certificate in respect of pack size for finished products.

Labelling requirements

The cosmetics must be appropriately labelled and the details must correspond with the Registration Certificate. The label should include, among other things:

• Name of the cosmetic;
• Registration Certificate number;
• Name and address of the registration certificate holder responsible for marketing in India;
• Name and address of the manufacturer;
• Address of the actual manufacturing premises;
• Batch, lot or serial number; and
• Use-before date or expiry date.

A particularly important condition is that the remaining shelf life of a cosmetic should not be more than six months short of its expiry/use-before date at the time of import. In other words, cosmetics having a use-before/expiry period of six months or less remaining from the date of import should not be imported.

Other documents and declarations

The importer must also provide:

• Self-certified copy of the licensed premises where the cosmetics will be stored;
• Certificate of Analysis (COA) or batch-release certificate for each batch;
• Declaration that the cosmetic does not contain hexachlorophene;
• Manufacturer's declaration that no animal has been used for testing of the cosmetics; and
• Importer's undertaking that the packaging is not damaged, broken or destroyed and that the contents have not deteriorated.

Where there is any discrepancy or doubt, the consignment is to be referred to the concerned CDSCO/Assistant or Deputy Commissioner (Imports) Port Office.

Checklist II - Drugs: APIs and Finished Formulations

The second checklist concerns the import of Active Pharmaceutical Ingredients (APIs) and finished drug formulations.

Registration and Import Licence

The importer must submit:

• Self-certified copy of the Registration Certificate in Form 41; and
• Import Licence in Form 10.

The invoice should mention the name of the item and correspond with the RC and Import Licence, particularly with respect to pack size in the case of finished products.

Documents required

The checklist requires verification of:

• Invoice;
• Packing list;
• Certificate of country of origin;
• Labels and markings;
• Certificate of Analysis for each batch; and
• Licence/documentation relating to the premises where the drugs will be stored.

The storage premises should be covered by an appropriate valid wholesale or manufacturing licence.

Drug labelling

The label should correspond with the Registration Certificate and Import Licence with respect to:

• Name of the drug;
• Import Licence number;
• Name and address of the import licence holder;
• Name and address of the actual manufacturer;
• Storage conditions; and
• Composition of each unit in the case of finished products.

The label should additionally mention:

• Batch/lot/serial number;
• Manufacturing date; and
• Expiry date or, in the case of APIs, the applicable re-test date.

Residual shelf life

A significant compliance requirement concerns Residual Shelf Life (RSL). The Circular provides that the residual shelf life is to be calculated as on the date of import. More than 60% residual shelf life is permitted. Where the residual shelf life is less than 60%, the consignment is required to be referred to the concerned CDSCO port office.

QR code requirement for APIs

For APIs/bulk drugs, the label must contain a readable QR code capable of retrieving prescribed information. The QR code is required to contain information such as:

• Unique product identification code;
• Name of the API;
• Brand name, if any;
• Name and address of manufacturer;
• Batch number;
• Batch size;
• Manufacturing date;
• Expiry/retesting date;
• Serial Shipping Container Code;
• Import Licence number; and
• Special storage conditions, where applicable.

This requirement adds an important layer of traceability to API imports.

Checklist III - Drugs for Personal Use and Certain Institutional Imports

The third checklist applies to:

• Drugs imported for personal use; and
• Small quantities of new drugs imported by a Government Hospital or Autonomous Medical Institution for treatment of patients.

The key documents are:

• Self-certified copy of import permission in Form 12B or Form 11A/CT-25;
• Self-certified copy of invoice; and
• Packing list.

Most importantly, the quantity actually imported must correspond with the quantity specified in the import permission. Thus, Customs verification in these cases focuses particularly on the validity of the permission and the quantity imported.

Checklist IV - Drugs Imported for Examination, Test or Analysis

For drugs imported for examination, testing or analysis, the importer is required to produce:

• Self-certified copy of the import permission granted in Form 11 or CT-17 for importing a new drug or investigational new drug;
• Invoice; and
• Packing list.

The invoice should contain the name of the item and quantity corresponding with the import permission. The quantity actually imported must also tally with the quantity permitted.

Important exemptions and special situations

The Circular also identifies certain situations where Registration Certificate and Import Licence requirements do not apply.

These include:

• Drugs in transit through India to foreign countries;
• Raw materials/bulk drugs imported under Advance Authorisation where they are not required to be sold or distributed in India; and
• Certain imports by 100% EOUs, EPZs and SEZs that are exempted from registration requirements under applicable ITC Policy provisions.

However, as a precaution against misuse, an undertaking from the importer is to be obtained and details of the import are to be communicated to the concerned State Drug Controller/Zonal Officer/DCGI for post-import verification. Where discrepancies or doubts arise, the consignment should be referred to the concerned CDSCO port office.

Checklist V - Medical Devices and IVDs

The fifth checklist applies to Medical Devices, including in Vitro Diagnostic (IVD) kits/devices.

Import Licence - The importer is required to provide a self-certified copy of the Import Licence in Form MD-15 issued by CDSCO. For Class A non-sterile and non-measuring medical devices, the applicable registration number is to be verified.

Commercial documents - The following are required:

• Invoice;
• Packing list; and
• Certificate of country of origin.

The invoice should mention the name of the item and correspond with Form MD-15, including pack size where applicable.

Labelling - The medical device label must correspond with the import licence in relation to:

• Name of the item;
• Import Licence number;
• Name and address of the import licence holder;
• Name and address of the actual manufacturer; and
• Storage conditions.

The label should also contain:

• Batch/lot/serial number;
• Manufacturing date; and
• Expiry date, where applicable.

Residual Shelf Life for Medical Devices - The Circular establishes specific minimum residual shelf-life requirements depending upon the shelf life of the device:

The residual shelf life is to be calculated from the date of import.

Other documents - The importer must also provide:

• COA or quality certificate for each batch;
• Self-certified copy of the licensed premises where the medical devices are to be stored; and
• Undertaking regarding the condition of the packaging and contents.

Checklist VI - Special Imports of Medical Devices

The sixth checklist deals with medical devices imported:

• For clinical investigation;
• For testing;
• For evaluation;
• For demonstration;
• For training;
• By Government Hospitals or Statutory Medical Institutions for treatment of patients; or
• In small quantities for personal use.

The importer must provide a self-certified copy of the relevant:

• Import Licence in Form MD-17 or MD-19; or
• Permission in Form MD-21.

The invoice, packing list and certificate of country of origin are also required. The name and quantity of the goods imported must correspond with the import permission/licence.

Checklist VII - Raw Materials and Components for Medical Devices

The seventh checklist is particularly relevant to manufacturers of medical devices. It covers raw materials and components such as:

• Substances;
• Pieces and parts;
• Software;
• Firmware;
• Labelling; and
• Assemblies,

which are intended to form part of the finished, packaged and labelled medical device. The importer must provide:

• Self-certified copy of the manufacturing licence in Form MD-05 for Class A and B devices; or
• Manufacturing licence in Form MD-09 for Class C and D devices.

The importer must also submit:

• Invoice;
• Packing list; and
• Certificate of country of origin.

Responsibility of Customs officers

The Circular specifically requests field formations to sensitise Customs officers regarding verification of the prescribed documents at the time of granting OOC. This is an important procedural aspect. Even where a Bill of Entry has been facilitated, the Customs officer is expected to ensure that the applicable CDSCO-related documentation has been submitted and verified before clearance. Therefore, importers should not assume that facilitation automatically eliminates the requirement to produce regulatory documents. The Circular effectively establishes a document-verification checkpoint at the OOC stage until the relevant regulatory information is integrated with SWIFT 2.0.

Responsibility of the Trade

The CBIC has also requested that the trade fraternity be informed through suitable Public Notices regarding the documentation requirements. Importers are specifically encouraged to upload the required documents on e-SANCHIT. Early and accurate uploading of documents can facilitate quicker verification and help avoid delays at the time of OOC. For importers dealing regularly in these products, it would therefore be prudent to maintain a standard document set corresponding to the particular product category and ensure that the documents uploaded on e-SANCHIT are:

• Valid;
• Legible;
• Complete;
• Consistent with the Bill of Entry;
• Consistent with the applicable CDSCO licence/permission; and
• Product- and batch-specific wherever required.

Practical compliance implications

Circular No. 40/2026-Customs is likely to have considerable practical significance for businesses importing regulated healthcare products.

1. Facilitation does not mean exemption from regulatory requirements - A facilitated Bill of Entry may still be subjected to verification of mandatory CDSCO documentation before OOC. Importers should therefore distinguish between customs assessment facilitation and regulatory compliance under the Drugs and Cosmetics framework.

2. Document consistency becomes critical - Discrepancies between the invoice, packing list, licence, registration certificate, labels, pack size, quantity, batch information or manufacturer details can result in the consignment being referred to CDSCO. Importers should conduct an internal document check before filing the Bill of Entry.

3. Shelf-life compliance requires advance planning - For cosmetics, drugs and medical devices, the applicable shelf-life requirements can directly affect whether the goods can be cleared. Importers should therefore monitor remaining shelf life before shipment rather than discovering a deficiency at the Indian port.

4. Batch-level documentation is important - For drugs and medical devices, COAs or quality certificates may be required for individual batches. These should be available and should correspond with the relevant product and licence particulars.

5. Labelling must be checked before shipment - The requirements relating to product name, manufacturer, licence number, batch number, manufacturing date, expiry/re-test date, storage conditions and other particulars mean that labelling compliance should ideally be verified before dispatch from the exporting country.

6. e-SANCHIT preparation can reduce delays - Since the CBIC has specifically requested importers to upload the necessary documents on e-SANCHIT, maintaining a ready-to-upload document package can's objective of improving the Ease of Doing Business requires faster customs clearance, but healthcare-related products cannot be treated solely as ordinary commercial imports because their quality, safety, licensing and regulatory status have implications beyond customs revenue and tariff assessment effect is to require Customs officers to verify specified CDSCO-related documents before granting OOC in facilitated Particular attention should be given to licences and permissions, product descriptions, labelling, batch information, certificates of analysis, storage premises and residual shelf significantly facilitate the clearance process.

A compliance checklist for importers - Before importing cosmetics, drugs or medical devices, businesses may consider following a simple internal process:

1. Identify the correct category under Checklist I to VII.
2. Verify the applicable CDSCO registration, licence or permission.
3. Check that the importer details match across all documents.
4. Match product descriptions and pack sizes with the relevant licence/registration.
5. Verify manufacturer details and manufacturing premises.
6. Check batch/lot/serial numbers.
7. Verify manufacturing and expiry/re-test dates.
8. Calculate applicable residual shelf life as on the date of import.
9. Obtain the required COA/quality or batch-release certificate.
10. Verify labelling and marking requirements.
11. Obtain the applicable storage-premises licence.
12. Prepare the required declarations and undertakings.
13. Upload all relevant documents on e-SANCHIT.
14. Where there is uncertainty, obtain clarification from the concerned CDSCO authority before clearance.

Broader significance - Circular No. 40/2026-Customs represents an attempt to combine trade facilitation with effective regulatory oversight.

The Government's objective of improving the Ease of Doing Business requires faster customs clearance, but healthcare-related products cannot be treated solely as ordinary commercial imports because their quality, safety, licensing and regulatory status have implications beyond customs revenue and tariff assessment. The seven checklists provide Customs officers with a structured framework for verification while giving importers greater clarity about the documents expected at the clearance stage. The approach may also help reduce ad-hoc document requirements by establishing a more standardised verification mechanism across Customs formations.

Conclusion

Circular No. 40/2026-Customs is an important compliance development for importers of cosmetics, drugs, APIs, finished pharmaceutical formulations, medical devices, IVDs and medical-device components. Its immediate practical effect is to require Customs officers to verify specified CDSCO-related documents before granting OOC in facilitated Bills of Entry, particularly while integration under SWIFT 2.0 remains under process.

For trade, the key message is clear: regulatory documentation should be complete, accurate and uploaded on e-SANCHIT well before clearance is sought. Particular attention should be given to licences and permissions, product descriptions, labelling, batch information, certificates of analysis, storage premises and residual shelf-life requirements.

For Customs, the checklists provide a common verification framework intended to ensure that trade facilitation does not compromise mandatory regulatory controls.

Ultimately, the Circular seeks to create a more predictable and transparent clearance process by clearly identifying the compliance requirements applicable to different categories of regulated healthcare imports. Its effectiveness will depend upon consistent implementation by field formations, timely availability of CDSCO documentation and proactive compliance by importers.

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