The Central Board of Indirect Taxes & Customs (CBIC), Department of Revenue, Ministry of Finance, has issued detailed compliance checklists for imports of Cosmetics, Drugs and Medical Devices to be verified by Customs officers before granting Out-of-Charge in PGA-facilitated Bills of Entry. The instructions have been issued through Circular No. 40/2026-Customs dated September 03, 2026.
The measure follows initiatives undertaken by the Central Drugs Standard Control Organization (CDSCO) in line with the Government’s objective of enhancing Ease of Doing Business and increasing facilitation for imports of cosmetics, drugs and medical devices. These products are subject to mandatory statutory compliances relating to licences, permissions, registration certificates and other requirements under the Drugs and Cosmetics Act, 1940 and the Rules made thereunder.
CBIC has noted that integration of the relevant regulatory documents under SWIFT 2.0 is presently under process. Pending such integration, Customs field formations have been advised to exercise due diligence before granting Out-of-Charge for these imports. CDSCO has accordingly provided seven category-specific checklists setting out the documents and regulatory particulars that Customs officers are required to verify.
The seven prescribed compliance checklists cover Cosmetics; Drugs including Active Pharmaceutical Ingredients (APIs) and finished formulations; specified imports of drugs for personal use or for treatment of patients by Government Hospitals/Autonomous Medical Institutions; drugs imported for examination, test or analysis; Medical Devices including in-vitro diagnostic kits/devices; specified imports of Medical Devices for clinical investigation, testing, evaluation, demonstration, training or personal use; and raw materials/components intended for manufacture of Medical Devices.
For cosmetics, the checklist requires verification of documents such as the applicable CDSCO Registration Certificate, invoice, packing list, certificate of country of origin, prescribed labelling particulars, proof of licensed storage premises, Certificate of Analysis or batch release certificate and specified declarations and undertakings. The checklist also provides for referral to the concerned CDSCO port office in cases involving new cosmetics under Form COS-3 or where discrepancies or doubts arise.
For drugs, including APIs and finished formulations, Customs officers are required to verify the Registration Certificate and Import Licence, wherever applicable, along with invoices, packing lists, country-of-origin certificate, labels and markings, Certificate of Analysis and licensed storage premises. The prescribed checks also cover batch details, manufacturing and expiry/re-test dates, storage conditions and, in the case of APIs, specified QR-code particulars. The Circular further provides that where the residual shelf life is less than 60 per cent, the consignment should be referred to the concerned CDSCO port office.
For medical devices, including IVDs, the checklist provides for verification of the Import Licence in Form MD-15, or the registration number in the case of specified Class A devices, together with invoices, packing lists, country-of-origin certificates, labelling particulars, quality/analysis certificates and details of licensed storage premises. The Circular also specifies minimum Residual Shelf Life (RSL) requirements based on the total shelf life of the medical device—at least 40 per cent for devices with a 90-day shelf life, 50 per cent for shelf life between 90 and 365 days, and 60 per cent where shelf life exceeds 365 days.
Separate requirements have also been prescribed for medical devices imported for clinical investigations, test, evaluation, demonstration, training, treatment of patients or personal use, where the applicable Import Licence or permission in Form MD-17, MD-19 or MD-21, along with supporting commercial documents, is to be verified. For raw materials and components intended for manufacture of medical devices, the relevant manufacturing licence in Form MD-05 for Class A & B or Form MD-09 for Class C & D, along with prescribed import documents, is required to be checked.
CBIC has directed its field formations to be suitably sensitised for verification of these documents at the time of Out-of-Charge. The trade fraternity is also to be informed through suitable Public Notices and advised to upload the required documents on e-SANCHIT, so as to facilitate expedited Customs clearance of such consignments.
The Circular is expected to strengthen regulatory compliance at the Customs clearance stage while supporting greater facilitation of legitimate imports of regulated healthcare and cosmetic products during the ongoing integration of documentation requirements under SWIFT 2.0.
The Circular can be accessed at: https://taxinformation.cbic.gov.in/view-pdf/1003342/ENG/Circulars
