Streptokinase

Streptokinase enzyme for pharmaceutical import

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3507 90 61 (Streptokinase) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. A Registration Certificate for Drugs (document code 101DC1) and an Import Licence for Drugs (document code 9111DC) must be uploaded in e-Sanchit before customs out-of-charge is granted.

What this is

HSN code

3507 90 61

Chapter

35 · Albuminoidal substances; modified starches; glues; enzymes

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration Certificate from CDSCO
Import Licence from CDSCO
Batch Release Certificate from manufacturer

Compliance steps

1
Obtain a Registration Certificate for Drugs (document code 101DC1) and an Import Licence for Drugs (document code 9111DC) from CDSCO before shipment. Both documents must be uploaded in e-Sanchit; customs out-of-charge will not be granted until the proper officer confirms these uploads.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101DC1 and 9111DC
2
Upload the Certificate of Analysis for the drug batch (document code 0010DC), the Batch Release Certificate (document code 0030DC), and the Label of Consignment (document code 0110DC) in e-Sanchit at the bill-of-entry stage. All five mandatory documents must be present before out-of-charge is granted.
e-Sanchit document codes 0010DC, 0030DC, and 0110DC

A word of counsel

The most common error on this tariff line is submitting the Import Licence and Registration Certificate while omitting the Batch Release Certificate or Certificate of Analysis, treating them as supplementary rather than mandatory. All five document codes — 0010DC, 0030DC, 0110DC, 101DC1, and 9111DC — carry equal weight at out-of-charge; a single missing upload holds the entire consignment, and streptokinase's cold-chain requirements make detention particularly costly in demurrage and product degradation.

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Frequently asked

Does HSN 3507 90 61 require BIS certification?

No, streptokinase as a pharmaceutical enzyme is not covered by any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring a Registration Certificate and Import Licence for Drugs.

Which document codes must be uploaded in e-Sanchit for streptokinase imports?

Five document codes are mandatory: Certificate of Analysis — Drug (0010DC), Batch Release Certificate (0030DC), Label of Consignment (0110DC), Registration Certificate for Drugs (101DC1), and Import Licence for Drugs (9111DC). All must be uploaded before the customs proper officer grants out-of-charge.

What happens if the consignment arrives before the Registration Certificate is obtained?

Consignments without a current Registration Certificate for Drugs are detained at the port of entry; continued non-production exposes the importer to confiscation under the Drugs and Cosmetics Act, 1940 and accruing demurrage and ground rent until the documentation deficit is cured or the goods are re-exported.

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