CBIC Introduces Mandatory Compliance Checklists for Drug, Cosmetic and Medical Device Imports

CBIC-500401/4/2023-SINGLE WINDOW SECTION-CBEC 1/158624/2026

Circular No. 40/2026-Customs

F. No. CBIC-510401/4/2023

Government of India
Ministry of Finance
Department of Revenue
(Central Board of Indirect Taxes and Customs)
16049, Kartavya Bhavan-1, New Delhi

Date:03-09-2026

To,

1. All Principal Chief Commissioners / Chief Commissioners of Customs /Customs
   (Preventive) / Customs & Central Taxes
2. All Principal Commissioners / Commissioners of Customs / Customs
   (Preventive)
3. Pr. Director General, DGARM,
4. Pr. Director General, DG SYSTEMS

Sir/Madam,

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— reg.

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

Checklist III — 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.

Yours Sincerely,