Oxyphen butazone, phenyl butazone and formulations thereof

Oxyphenbutazone and phenylbutazone medicament formulations

MEFCC CLEARANCE

HSN 3004 90 64 (Oxyphen butazone, phenyl butazone and formulations thereof) 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 as Restricted under the ITC (HS) import policy, and mandatory e-Sanchit document uploads must be completed before customs out-of-charge is granted.

What this is

HSN code

3004 90 64

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (drug registration and import licence)

Customs documentation

Registration certificate from CDSCO
Import licence 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 the Central Drugs Standard Control Organisation before shipment. Both the registration certificate (document code 101dc1) and the import licence for drugs (document code 9111dc) must be uploaded in e-Sanchit prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · e-Sanchit 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). Customs proper officers verify these on PGA-facilitated bills before granting out-of-charge.
CCR e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most common error on this tariff line is conflating it with oxytocin-related prohibitions noted in adjacent CCR entries — the prohibition on oxytocin imports under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 does not apply to oxyphenbutazone or phenylbutazone formulations. However, the full five-document e-Sanchit bundle is non-negotiable: consignments presented without a current batch release certificate or a valid drug import licence are detained at the port pending CDSCO-routed NOC resolution, accruing demurrage and ground rent.

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Frequently asked

Does HSN 3004 90 64 require BIS certification?

No, pharmaceutical medicament formulations under this tariff line are not subject to any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with a Restricted ITC (HS) policy overlay administered by DGFT.

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

Five documents 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 present in e-Sanchit before customs out-of-charge.

Does the prohibition on oxytocin imports affect this HSN?

No. The oxytocin import prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to oxytocin specifically, not to oxyphenbutazone or phenylbutazone; importers of reference standards for test and analysis must nonetheless hold a test licence from CDSCO.

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