Notification/Circular No.: 40/2026-Customs dated 03-09-2026
Applicable Act/Rule: Drugs and Cosmetics Act, 1940
Applicable Section/Rule: Checklists I to VII of Annexure-A
Central Board of Indirect Taxes and Customs (CBIC), Department of Revenue, Ministry of Finance, has issued Circular No. 40/2026-Customs prescribing checklists for mandatory compliance documentation relating to Cosmetics, Drugs and Medical Devices, to be verified by Customs officers before granting out-of-charge in cases of PGA-facilitated Bills of Entry.
The Circular notes that the Central Drugs Standard Control Organization (CDSCO), in line with the Government's objective of enhancing the Ease of Doing Business, is taking measures to increase facilitation for these product categories, which require licenses, permissions and registration certificates under the Drugs and Cosmetics Act, 1940 and Rules made thereunder. Since integration of these documents under SWIFT 2.0 is still under process, field formations have been directed to exercise due diligence when granting out-of-charge for such imports.
CDSCO has provided seven checklists covering distinct product categories: Checklist I for Cosmetics; Checklist II for Drugs, including Active Pharmaceutical Ingredients and finished formulations; Checklist III for import of drugs for personal use or import of small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for patient treatment; Checklist IV for import of drugs for examination, test or analysis; Checklist V for Medical Devices, including in-vitro diagnostic kits and devices; Checklist VI for import of Medical Devices; and Checklist VII for import of raw materials or components used in manufacturing Medical Devices. For cosmetics, the requirements include a self-certified Registration Certificate in Form COS-2 or COS-4A, matching invoice and packing list details, a certificate of country of origin, correctly matched labelling, a certificate of analysis for each batch, and a declaration that the Use Before or expiry date is not more than six months from the date of import. For drugs, requirements include a Registration Certificate in Form 41 with an Import License in Form 10, matching labelling particulars, a QR code on API labels carrying specified product and manufacturing details, and a residual shelf life of more than 60% at the date of import, failing which the consignment must be referred to the concerned CDSCO port office.
Field formations have been asked to sensitize officers to check these documents at the time of out-of-charge, and the trade fraternity is to be informed through a public notice of the requirement to upload the necessary documents on e-SANCHIT to facilitate expedited clearance. Any implementation difficulties are to be brought to the notice of the Board. The Circular was issued by Vivek Kumar, OSD (Customs Policy Wing), with a copy for information to the Drug Controller General of India, CDSCO, New Delhi.
Link: https://taxinformation.cbic.gov.in/view-pdf/1003342/ENG/Circulars
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