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Of Bio-chemic system

Biochemic system mixed medicaments, not retail-packed

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3003 90 15 (Of Bio-chemic system) is subject to import controls under the Drugs and Cosmetics Act, 1940, with customs clearance contingent on verified documentation at the bill-of-entry stage. Three mandatory documents — a Certificate of Analysis, a Batch Release Certificate, and a consignment label — must be uploaded in e-Sanchit before out-of-charge is granted.

What this is
HSN code
3003 90 15
Chapter
30 · Pharmaceutical products
Primary regulator
CDSCO · Drugs and Cosmetics Act, 1940
Customs documentation
  • Certificate of Analysis from manufacturer
  • Batch Release Certificate from manufacturer
  • Consignment label from importer
Compliance steps
  1. 1
    Upload the Certificate of Analysis (document code 0010dc) for the imported biochemic medicament in e-Sanchit prior to filing the bill of entry. The certificate must correspond to the specific batch being imported and confirm the product's compositional and quality parameters.
    CCR mandatory document requirement · document code 0010dc
  2. 2
    Upload the Batch Release Certificate (document code 0030dc) and the consignment label (document code 0110dc) in e-Sanchit before the bill of entry is processed. The proper officer is required to verify all three documents are present before granting out-of-charge.
    CCR mandatory document requirement · document codes 0030dc, 0110dc
A word of counsel

The most common error on this tariff line is treating biochemic system medicaments as analogous to homeopathic or ayurvedic preparations and overlook the drug-documentation triad specific to Chapter 30 mixed medicaments. All three e-Sanchit uploads — Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and consignment label (0110dc) — are independently mandatory; a bill of entry with even one missing document will be held without out-of-charge, accruing demurrage and ground rent until the gap is rectified.

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Frequently asked
Does HSN 3003 90 15 require BIS certification?
No, no BIS Quality Control Order covers biochemic system medicaments under Chapter 30. Import is governed by the Drugs and Cosmetics Act, 1940, with mandatory document verification — Certificate of Analysis, Batch Release Certificate, and consignment label — at the bill-of-entry stage.
Which document codes must be uploaded in e-Sanchit for this tariff line?
Three documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and the consignment label (0110dc); all three must be uploaded before the proper officer grants out-of-charge.
Do PGA-facilitated bills of entry bypass the document verification requirement?
No. Even where a bill has not been routed through the PGA for a formal NOC, the proper officer must independently verify that all three mandatory documents are present in e-Sanchit before issuing out-of-charge.
Last verified against gazette notifications: 2026-05-16. Source: CDSCO / Indian Customs CUSDATA.
Related
ChapterChapter 30 · Pharmaceutical productsHSNMEDICAMENTS (EXCLUDING GOODS OF HEADING 3002, 3005 OR 3006) CONSISTING OF TWO OR MORE CONSTITUENTS WHICH HAVE BEEN MIXED TOGETHER FOR THERAPEUTIC OR PROPHYLACTIC USES, NOT PUT UP IN MEASURED DOSES OR IN FORMS OR PACKINGS FOR RETAIL SALEHSNOther :