CBIC Prescribes Mandatory Document Checklists for Customs Clearance of Cosmetics, Drugs and Medical Devices

Circular No. 40/2026-Customs dated 3 September 2026 lays down checklists to be verified by Customs officers before granting Out-of-Charge (OOC) for PGA-facilitated Bills of Entry covering cosmetics, drugs and medical devices.

1. Objective

o The Central Drugs Standard Control Organization (CDSCO) is facilitating imports of cosmetics, drugs and medical devices as part of the Government's Ease of Doing Business initiative.

o These products require mandatory licences, permissions and registration certificates under the Drugs and Cosmetics Act, 1940 and Rules.

o As integration of these documents into SWIFT 2.0 is still underway, Customs officers must exercise due diligence before granting OOC.

2. Seven categories covered

o Cosmetics

o Drugs – API and finished formulations

o Drugs for personal use / small quantities for Government hospitals or autonomous medical institutions

o Drugs imported for examination, testing or analysis

o Medical Devices, including IVDs

o Medical Devices for clinical investigation, testing, evaluation, demonstration, training, etc.

o Raw materials/components used in manufacture of Medical Devices.

3. Customs verification at OOC stage

o Field formations are required to verify the prescribed documents before granting Out-of-Charge.

o Trade should be informed through a suitable Public Notice about the documentation requirements.

o Importers are encouraged to upload the required documents on e-SANCHIT to facilitate faster clearance.

4. Cosmetics – key requirements

o CDSCO Registration Certificate: Form COS-2/COS-4A.

o Invoice, packing list and country-of-origin certificate.

o Labels must correspond with the registration certificate and contain prescribed details such as manufacturer, batch/lot/serial number and expiry/use-before date.

o Residual validity/use-before period must be more than six months from the date of import.

o Licensed storage premises and batch-wise Certificate of Analysis (COA)/batch release certificate.

o Declaration that the cosmetic does not contain hexachlorophene and that no animal was used for testing.

o Importer undertaking regarding intact packaging and non-deterioration of contents.

5. Drugs – API and finished formulations

o Registration Certificate in Form 41 along with Import Licence in Form 10.

o Invoice, packing list, country-of-origin certificate and labels/markings.

o Labels must match the RC/Import Licence regarding drug name, licence details, manufacturer, storage conditions and composition.

o Batch/lot/serial number, manufacturing date and expiry/re-test date must be indicated.

o Residual shelf life above 60% is permitted; consignments below 60% are to be referred to the concerned CDSCO port office.

o API/bulk-drug labels must also carry a readable QR code containing specified information, including product identification, manufacturer, batch details, expiry/retest date and import licence number.

6. Drugs for personal use / Government hospitals

o Self-certified import permission in Form 12B or Form 11A/CT-25.

o Invoice and packing list.

o Quantity imported must correspond with the quantity authorised in the import permission.

7. Drugs for examination, testing or analysis

o Import permission in Form 11 or CT-17 for new/investigational drugs.

o Invoice and packing list.

o Item names and quantities must correspond with the import permission.

8. Specified exemptions/relaxations for drugs

o Registration Certificate and Import Licence are not required for drugs in transit through India to foreign countries.

o They are also not required for bulk drugs imported under Advance Authorisation where the goods are not intended for sale/distribution in India.

o Certain imports by 100% EOUs/EPZs/SEZs may be exempt from registration requirements; however, an undertaking is to be obtained and import details reported to the relevant drug authorities for post-import checks.

9. Medical Devices and IVDs

o Import Licence in Form MD-15 issued by CDSCO; for Class A non-sterile/non-measuring devices, the prescribed registration number applies.

o Invoice, packing list and country-of-origin certificate.

o Labels must match the import licence and contain manufacturer, licence-holder, storage and identification details.

o Batch/lot/serial number, manufacturing and expiry dates are required.

o Minimum Residual Shelf Life (RSL):

§ 40% for devices with 90-day shelf life;

§ 50% for shelf life between 90 and 365 days;

§ 60% for shelf life exceeding 365 days.

o Batch-wise COA/quality certificate, licensed storage premises and importer undertaking are also required.

10. Medical Devices for special purposes

o For clinical investigations, testing, evaluation, demonstration, training, investigational use by Government/statutory institutions, or small quantities for personal use:

§ Import licence in Form MD-17/MD-19 or permission in Form MD-21.

§ Invoice, packing list and country-of-origin certificate.

§ Invoice quantity must match the quantity authorised.

11. Raw materials/components for Medical Devices

o Manufacturing licence in Form MD-05 for Class A/B devices or Form MD-09 for Class C/D devices.

o Invoice, packing list and country-of-origin certificate.

o Components include substances, parts, software, firmware, labelling and assemblies intended for incorporation into finished medical devices.

12. Referral to CDSCO

o Where discrepancies or doubts arise, the consignment is to be referred to the concerned CDSCO Office of the Assistant/Additional Drugs Controller (ADC-I), Port Office.

Key takeaway

The Circular effectively shifts the prescribed CDSCO compliance-document verification to the Customs OOC stage for PGA-facilitated Bills of Entry, pending full integration of these documents into SWIFT 2.0, while promoting e-SANCHIT-based document submission for expedited clearance.

[CBIC Circular No. 40/2026-Customs dated 3 September 2026]

Subject: Checklists for mandatory compliance for Cosmetics/Drugs/Medical Devices to be verified by the Customs officer before granting out-of-charge in case of PGA facilitated Bills of Entry.

The Central Drugs Standard Control Organization (CDSCO) in alignment with the Government’s objective of enhancing the 'Ease of Doing Business’ is taking measures to increase the facilitation of Cosmetics, Drugs and Medical Devices.

2. The said products require certain mandatory compliance in terms of licenses, permissions, registration certificates, etc., as per the provisions of the Drugs and Cosmetics Act, 1940 and Rules made thereunder. Considering the fact that integration of these documents under SWIFT 2.0. is under process, the field formations should exercise due diligence while giving out-of-charge in case of such imports. The CDSCO has provided checklists for the following 7 such categories of products and a list of documents to be verified by the Customs officer against each category of the products. (Annexure-A may be referred for document checklisf)

Checklist I— Cosmetics

Checklist Il — Drugs (API i.e. Active Pharmaceutical Ingredient, finished formulation)

Checklist Ill — Import of Drugs

(a) For personal use.

(b) Import of small quantities of new drug by a Government Hospital or Autonomous Medical Institution for the treatment of patients.

Checklist IV — Import of Drugs for examination, test or analysis

Checklist V - Medical Devices (including IVD’s i.e. Invitro Diagnostics Kits/Devices)

Checklist VI — Import of Medical Devices

Checklist VII — Import of raw materials / components (substance, piece, parts, software, firmware, labelling or assembling which is intended to be included as part of the finished, packaged and labelled device) used for manufacture of Medical Devices.

3. Accordingly, it is requested that the field formations may be sensitized to check the documents at the time of out of charge. The trade fraternity may also be informed through a suitable public notice about the requirement of such documents with a request to upload the required documents on e-SANCHIT to facilitate expedited clearance.

4. Difficulty faced, if any, in implementation of this Circular may be immediately brought to the notice of the Board.

ANNEXURE-A

Checklist for the custom official to be verified before Out-of-Charge

The Checklists I to VII covering various class of commodities are as detailed below:

Checklist I: Cosmetics

S.No.	Particular
1	*Self-Certified copy of Registration Certificate (RC) in Form COS-2 in case of fresh registration or Form COS-4A in case of subsequent registration issued by CDSCO
2	Self-certified copy of invoice. • The invoice of the consignment shall mention the name of the cosmetics and match with the RC with respect to the Pack size (in case of finished product)
3	Self-certified copy of packing list.
4	Self-certified copy of the certificate of country of origin.
5	Items shall be labelled and match with RC w.r.t. a. Name of the cosmetics b. RC No. of the cosmetics and the name and address of the registration certificate holder for marketing the product in India. c. The name and address of the manufacturer and address of actual premises where the cosmetic has been manufactured. In addition to above each item shall be labelled to include: d. Batch number or lot number or serial number. e. use before or date of expiry ** No cosmetics shall be imported unless the Use Before/expiry is not more than six months from the date of import.
6	Self-Certified copy of the licensed premises where cosmetics are to be stored.
7	Self-Certified copy of Certificate of analysis (COA) or batch release certificate for each batch of cosmetics item.
8	No cosmetic containing hexachlorophene shall be imported. A Declaration from importer/manufacturer in this regard shall be submitted.
9	Declaration by the manufacturer that no animal is used for testing of cosmetics.
10	Undertaking by the importer that the consignment packaging is not damaged/broken/destroyed and the content of cosmetic has not been deteriorated.

Note:

* In case of New Cosmetics to be imported under Form COS-3, the consignment shall be referred to concerned port office of CDSCO.

** No cosmetics shall be imported unless the Use Before/expiry is not more than six months from the date of import.

# In case of any discrepancies or doubts, the consignment shall be referred to the concerned CDSCO O/o ADC (I), Port Office

Checklist Il: Drugs (API i.e. Active Pharmaceutical Ingredient, finished formulation)

S.No.	Particular
1	Self-Certified copy of Registration Certificate (RC) in Form 41 along with Import License (IL) in Form 10
2	Self-Certified copy of invoice * The invoice of the consignment shall mention the name of the item and match with RC/IL with respect to the Pack size (in case of finished product).
3	Self-certified copy of packing list.
4	Self-certified copy of the certificate of country of origin.
5	Self-certified copy of labels and markings on the consignment. The Drug Items (API, Finished product) should be labelled and match with RC and IL with respect to the following:- a. Name of the drug b. IL No. and the name and address of the Import license holder. c. The name and address of the actual manufacturer where the drug has been manufactured. d. Storage condition. e. Composition of each unit in the case of a finished product.
	In addition to the above, each item should be labelled to include: a. Batch number or lot number, or serial number. b. Manufacturing date c. Expiry date. (re-test date in case of API). The residual shelf life is calculated on the date of import * More than 60% is allowed to import * less than 60%, the consignment should be referred to the concerned CDSCO port office d. The label in the case of API (bulk drugs) must bear a readable QR code which stores and retrieves the following information upon scanning: i. Unique product identification code, li. Name of the API, iii. Brand name (if any), 1/158624/2026 iv. Name and address of the manufacturer, v. Batch no., vi. Batch size, vii. Date of manufacturing, viii. Date of expiry or retesting, ix. Serial shipping container code, x. Import licence no. xi. Special storage conditions required (if any).
6	Self-Certified copy of Certificate of analysis (COA) for each batch imported and shall match with RC/IL w.r.t. - Name and Composition in case of finished product.
7	Self-Certified copy of the licensed premises where Drugs are to be stored (valid wholesale license/manufacturing license)
8	Undertaking by the importer that the consignment packaging is not damaged/broken/destroyed and the content of the drug/cosmetic has not deteriorated.

Note: The residual shelf life calculated on the date of import should be more than 60 %. If the Residual shelf life is less than 60%, the consignment should be referred to the concerned CDSCO port office.

Checklist III: Checklist for Import of Drugs

a. for personal use or,

b. Import of small quantities of the new drug by a Government Hospital or

Autonomous Medical Institution for the treatment of patients.

S.No.	Particular
1	Self-certified copy of Import permission granted in Form 12B or Form 11A/CT-25
2	Self-certified copy of invoice, packing list.
3	The quantity imported should tally with the quantity mentioned in the Import permission granted in Form 12B or Form 11A/CT-25

Checklist IV: Checklist for Import of drugs for examination, test or analysis

S.No.	Particular
1	Self-certified copy of Import permission granted in Form 11 or CT-17 (to import new drug or investigational new drug)
2	Self-certified copy of invoice, packing list. * The invoice of the consignment shall mention the name of the item(s) and quantity same as mentioned in the Import permission.
3	The quantity imported should tally with the quantity mentioned in the Import permission.

Note:

· Registration certificate and Import license are not required for the drugs in transit through India to foreign Countries or Raw material (bulk drug) imported under Advance Authorization and which are not required to be sold or distributed in India.

· If the drugs are imported under 100% EOU/EPZ/SEZ and as are exempted from the condition of registration as per the above ITC Policy Circulars. To control misuse, as a precautionary measure, an undertaking from the importer also to be taken, and the details of the import to be informed to the State Drug Controller / Zonal Officer / DCGI immediately for post-import check.

# In case of any discrepancies or doubts, the consignment shall be referred to the

concerned CDSCO O/o ADC (I), Port Office.

Checklist V: Medical Devices (Including IVD’s i.e., in vitro diagnostics kits/devices)

S.No.	Particular
1	Self-certified copy of Import License in Form MD-15 issued by CDSCO. *In case of Class A (non-sterile and non-measuring) medical devices, the registration number.
2	Self-Certified copy of invoice, packing list, certificate of country of origin * The invoice of the consignment shall mention the name of the item and match with the Import License (MD-15) with respect to the Pack size (in case of finished product).
3	Self-certified copy of packing list.
4	Self-certified copy of the certificate of country of origin.
5	Self-certified copy of labels and markings on the consignment. The medical devices shall be labelled and match with the import License (MD-15) w.r.t. a. Name of the item(s) b. Import license No. and the name and address of the Import license holder. c. The name and address of the actual manufacturer where the medical devices have been manufactured. d. Storage condition. In addition to the above, each item shall be labelled to include: e. Batch number or lot number, or serial number. f. Manufacturing date. g. Expiry date. (re-test date in case of API).
6	If the shelf life applicable item is imported, the Residual Shelf Life (RSL) should be calculated from the date of import. The minimum RSL requirements are: at least 40% for devices with a 90-day shelf life, at least 50% for shelf life between 90 and 365 days, and at least 60% for shelf life exceeding 365 days.
7	Self-certified copy of Certificate of Analysis (COA) or quality certificate for each batch imported, and shall match with the Import license in Form MD-15.
8	Self-certified copy of the licensed premises where medical devices are to be stored.
9	Undertaking by the importer that the consignment packaging is not damaged/broken/destroyed and the content of the drug/cosmetic has not been deteriorated.

Checklist VI: Medical Devices

a. for the purposes of Clinical Investigations Test or Evaluation or Demonstration or Training.

b. For investigational medical device by a Government Hospital or Statutory Medical Institution for the treatment of patients.

c. to import of small quantity of Medical Devices for personal use.

S.No.	Particular
1	Self-Certified copy of the Import license granted in Form MD-17 or MD-19 or permission in Form MD-21
2	Self-Certified copy of invoice, packing list, certificate of country of origin * The invoice of the consignment shall mention the name of the item(s) and quantity same as mentioned in the Import permission/license.

Checklist VII: Raw material/components (substance, piece, part, software, firmware, labelling, or assembly which is intended to be included as part of the finished, packaged, and labelled device) used for manufacture of Medical Devices

S.No.	Particular
1	Self-Certified copy of manufacturing license granted in Form MD-05 (for Class A & B) or MD-09 (for Class C & D).
2	Self-Certified copy of copy of invoice, packing list, certificate of country of origin

# In case of any discrepancies or doubts, the consignment shall be referred to the concerned CDSCO O/o ADC(I), Port Office.