Other articles of unhardened gelatin

Articles of unhardened gelatin (moulded, carved, worked)

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 9602 00 40 (Other articles of unhardened gelatin) is subject to drug-import controls administered by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940, where the articles fall within the definition of a drug or drug-delivery component. The mandatory documentation set — including a Registration Certificate (Drugs), Import Licence for Drugs, Batch Release Certificate, and Certificate of Analysis — must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

9602 00 40

Chapter

96 · Miscellaneous manufactured articles

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration Certificate (Drugs) from CDSCO
Import Licence for Drugs from CDSCO
Batch Release Certificate from manufacturer

Compliance steps

1
Ensure the foreign manufacturer holds a valid Registration Certificate (Drugs) (document code 101DC1) and that an Import Licence for Drugs (document code 9111DC) has been obtained before filing the bill of entry. Both documents must be uploaded in e-Sanchit prior to customs out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101DC1 and 9111DC
2
Upload the Certificate of Analysis-Drug (document code 0010DC), Batch Release Certificate (document code 0030DC), and Label of Consignment (document code 0110DC) in e-Sanchit at the bill of entry stage. The proper officer verifies all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
e-Sanchit document codes 0010DC, 0030DC, 0110DC

A word of counsel

The most common error on this tariff line is assuming that gelatin articles classified under Chapter 96 escape drug-import documentation because they are not finished pharmaceuticals. Where the article is a drug-delivery component — capsule shells, suppository moulds, or similar worked-gelatin forms — CDSCO treats it as falling within the Drugs and Cosmetics Act, 1940 regime, and all five e-Sanchit documents are mandatory regardless of the tariff heading.

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Frequently asked

Does HSN 9602 00 40 require BIS certification?

No, articles of unhardened gelatin under this tariff line are not within any BIS Quality Control Order regime. Where the article qualifies as a drug or drug-delivery component, import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, with the full drug-import documentation set required at the bill of entry.

Which five documents must be uploaded in e-Sanchit for this tariff line?

The mandatory documents are: Certificate of Analysis-Drug (0010DC), Batch Release Certificate (0030DC), Label of Consignment (0110DC), Registration Certificate (Drugs) (101DC1), and Import Licence for Drugs (9111DC) — all must be present before the proper officer grants out-of-charge.

Do all articles of unhardened gelatin under HSN 9602 00 40 attract the drug-import regime?

Only those articles that fall within the definition of a drug or drug-delivery component under the Drugs and Cosmetics Act, 1940 attract the full CDSCO documentation requirement; purely decorative or industrial gelatin articles may not, but misclassification risk means importers should seek a CDSCO product-scope determination before shipment.

Last verified against gazette notifications: 2026-05-16. Source: CDSCO / Indian Customs CUSDATA.