Papavarine hydrochloride

Papaverine hydrochloride medicament, retail-packed therapeutic doses

MEFCC CLEARANCE

HSN 3004 49 50 (Papaverine hydrochloride) 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 the ITC (HS) Restricted-import policy, and all mandatory clearance documents must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3004 49 50

Chapter

30 · Pharmaceutical products

Primary regulator

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

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 (document code 101dc1) and an import licence for drugs (document code 9111dc) from CDSCO before shipment. Both must be uploaded in e-Sanchit at the bill of entry stage; customs out-of-charge will not be granted without these documents.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit prior to filing the bill of entry. The proper officer is required to verify all five mandatory documents before granting out-of-charge.
CDSCO e-Sanchit mandatory document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is conflating papaverine hydrochloride with the oxytocin prohibition: the CCR for Chapter 30 carries an oxytocin-import prohibition (S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022) that does not extend to papaverine, but the presence of that prohibition in the bill-of-entry scrutiny record causes some consignments to be held pending additional verification. Ensure all five e-Sanchit document codes — 101dc1, 9111dc, 0010dc, 0030dc, and 0110dc — are uploaded before filing so the proper officer can distinguish the consignment clearly from restricted narcotics or prohibited substances under the same chapter.

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Frequently asked

Does HSN 3004 49 50 require BIS certification?

No. There is no BIS Quality Control Order covering papaverine hydrochloride medicaments. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with drug registration, an import licence, and batch-level documentation required at the bill of entry.

Which e-Sanchit document codes are mandatory for this tariff line?

Five documents must be uploaded: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc). Absence of any one of these will prevent customs out-of-charge.

Does the oxytocin import prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 affect papaverine hydrochloride imports?

No. The prohibition applies specifically to oxytocin; papaverine hydrochloride is a distinct pharmaceutical substance and is importable subject to standard CDSCO drug-registration and import-licence compliance.

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