Other

Bulk medicaments of mixed constituents, not retail-packed

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3003 49 00 covers multi-constituent medicaments mixed for therapeutic or prophylactic use, not put up in measured doses or retail packaging, and import is governed by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940. A drug registration certificate and an import licence for drugs are mandatory clearance instruments at the bill of entry, and consignments must carry a certificate of analysis and batch release certificate before customs out-of-charge.

What this is

HSN code

3003 49 00

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO
Certificate of analysis from manufacturer

Compliance steps

1
Secure a valid drug registration certificate (document code 101dc1) and an import licence for drugs (document code 9111dc) from CDSCO before the consignment is shipped. Both instruments must be current at the date of the bill of entry and uploaded in e-Sanchit prior to filing.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CUSDATA CCR
2
Upload all mandatory documents in e-Sanchit before seeking out-of-charge: certificate of analysis (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). The proper officer will verify each document code before granting out-of-charge.
e-Sanchit mandatory document checklist · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc per CUSDATA CCR

A word of counsel

The most common error on this tariff line is presenting only the import licence and overlooking the batch release certificate (0030dc) and the certificate of analysis (0010dc) as separate, co-mandatory uploads in e-Sanchit. A consignment that arrives with a valid registration certificate and import licence but without the batch-specific documents is detained at port pending documentary compliance, accruing demurrage and ground rent; the proper officer has no discretion to grant out-of-charge until all five document codes are verified in the system.

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Frequently asked

Does HSN 3003 49 00 require BIS certification?

No. No BIS Quality Control Order covers multi-constituent bulk medicaments under this tariff line. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring a drug registration certificate and import licence for drugs.

Are all five document codes in e-Sanchit mandatory for every shipment?

Yes. The certificate of analysis (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) are all mandatory uploads in e-Sanchit; the proper officer verifies each before granting out-of-charge.

Does this HSN cover medicaments already put up in measured doses or retail packs?

No. HSN 3003 49 00 is expressly limited to multi-constituent medicaments not put up in measured doses or in forms or packings for retail sale; products in measured doses or retail packs fall under heading 3004 and attract separate classification and CDSCO licensing requirements.

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