Ketorolac, nimesulide, nabumetone and nefopam

Analgesic and anti-inflammatory medicaments (ketorolac, nimesulide, nabumetone, nefopam)

MEFCC CLEARANCE

HSN 3004 90 67 (Ketorolac, nimesulide, nabumetone and nefopam) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. Mandatory e-Sanchit documentation — including a registration certificate, import licence, certificate of analysis, batch release certificate, and consignment label — must be uploaded before out-of-charge at the bill of entry. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay applicable to this tariff line.

What this is

HSN code

3004 90 67

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Certificate of Analysis 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 and an import licence for drugs from CDSCO covering each formulation to be imported. Both documents must be uploaded in e-Sanchit under document codes 101dc1 (registration certificate) and 9111dc (import licence for drugs) before filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2
Upload in e-Sanchit the Certificate of Analysis for drugs (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the Label of Consignment (document code 0110dc) before the proper officer grants out-of-charge. Absence of any one of these codes on a PGA-facilitated bill triggers detention pending manual verification.
e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is uploading the registration certificate without confirming that the specific formulation strength and dosage form are covered by the registration — CDSCO registrations are formulation-specific, and a certificate covering a 10 mg tablet does not authorise import of a 30 mg injection. A mismatch between the registered formulation and the shipped product results in consignment detention, demurrage, and potential confiscation under the Drugs and Cosmetics Act, 1940.

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Frequently asked

Does HSN 3004 90 67 require BIS certification?

No, pharmaceutical medicaments classified under this tariff line are not within the BIS Quality Control Order regime. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, with drug registration and import licensing as the operative requirements at the bill of entry.

Are all five e-Sanchit document codes mandatory even for PGA-facilitated bills?

Yes. Document codes 0010dc (Certificate of Analysis), 0030dc (Batch Release Certificate), 0110dc (Label of Consignment), 101dc1 (Registration Certificate), and 9111dc (Import Licence) must all be uploaded in e-Sanchit; the proper officer is required to verify their presence before granting out-of-charge regardless of the PGA facilitation status.

Does the oxytocin import prohibition under S.O. 2357(E) 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; import of oxytocin reference standards is permitted exclusively for test and analysis, subject to a test licence issued by DGCI/CDSCO, and does not affect the ketorolac, nimesulide, nabumetone, and nefopam formulations that form the primary scope of this tariff line.

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