Pyrazinamide and ethambutol

Pyrazinamide and ethambutol anti-tuberculosis medicaments

MEFCC CLEARANCE

HSN 3004 90 53 (Pyrazinamide and ethambutol) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licence requirements under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under ITC (HS) policy controls, and five mandatory documents must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3004 90 53

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO
Batch release certificate from CDSCO

Applicable Partner Government Agencies

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Obtain a valid drug registration certificate and import licence for drugs from CDSCO before shipment. Both the registration certificate (document code 101dc1) and the import licence (document code 9111dc) must be uploaded in e-Sanchit at the bill of entry stage prior to customs out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2
Upload all five mandatory documents in e-Sanchit before out-of-charge: Certificate of Analysis for drugs (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc). Bills not routed through CDSCO for NOC are subject to document verification by the proper officer.
e-Sanchit mandatory document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most common error on this tariff line is treating the drug registration certificate and the import licence as interchangeable or submitting only one of the two in e-Sanchit. Both are independent mandatory documents under the Drugs and Cosmetics Act, 1940 — an absent import licence (9111dc) triggers consignment detention at the bill of entry stage even where a current registration certificate (101dc1) is on record. Ensure all five document codes are uploaded and linked to the correct IRN before vessel arrival.

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Frequently asked

Does HSN 3004 90 53 require BIS certification?

No, pharmaceutical medicaments containing pyrazinamide and ethambutol are not covered by any BIS Quality Control Order. Import is governed by CDSCO drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with ITC (HS) policy controls administered by DGFT.

Which e-Sanchit document codes are mandatory at the bill of entry for this tariff line?

Five document codes are mandatory: Certificate of Analysis for drugs (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 customs out-of-charge.

Does the prohibition on oxytocin imports affect pyrazinamide and ethambutol consignments under this HSN?

No. The oxytocin import prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin formulations; pyrazinamide and ethambutol are distinct active pharmaceutical ingredients unaffected by that prohibition, though both are subject to the same CDSCO registration and import licence regime.

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