Propranolol, metoprolol, atenolol and labetalol

Beta-blocker medicaments (propranolol, metoprolol, atenolol, labetalol)

MEFCC CLEARANCE

HSN 3004 90 74 (Propranolol, metoprolol, atenolol and labetalol) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. Directorate General of Foreign Trade (DGFT) import policy applies as an overlay, and mandatory documents including the registration certificate and import licence must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3004 90 74

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 for drugs from CDSCO
Batch release certificate from manufacturer

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 the consignment is dispatched. Both documents must be uploaded in e-Sanchit at the bill of entry stage; customs out-of-charge will not be granted until these are verified.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis for drugs (document code 0010dc), the batch release certificate (document code 0030dc), and the label of the 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.
e-Sanchit document codes 0010dc, 0030dc, 0110dc · CDSCO import documentation framework

A word of counsel

The most common error on this tariff line is presenting a registration certificate that covers a different salt strength or dosage form — CDSCO registrations are product-specific, and a certificate for propranolol 40 mg tablets does not cover propranolol 80 mg tablets or an extended-release formulation. Customs officers are instructed to verify document codes individually; a mismatch between the registered product description and the bill of entry description results in consignment detention, demurrage, and potential referral back to CDSCO before out-of-charge is granted.

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Frequently asked

Does HSN 3004 90 74 require BIS certification?

No, beta-blocker medicaments are not within the BIS Quality Control Order regime; no BIS QCO covers finished pharmaceutical formulations under Chapter 30. Import is governed by CDSCO drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with DGFT import policy as an overlay.

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

Five documents are mandatory: Certificate of Analysis (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 bill of entry is processed for out-of-charge.

Does the oxytocin import prohibition affect this tariff line?

The oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to oxytocin as a substance, not to beta-blockers; propranolol, metoprolol, atenolol and labetalol are unaffected, though the standard CDSCO registration and import licence requirements remain fully applicable.

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