Ketamine

Ketamine medicaments for therapeutic or prophylactic use

MEFCC CLEARANCE · NDPS CLEARANCE

HSN 3004 90 96 (Ketamine) is subject to the Narcotic Drugs and Psychotropic Substances (NDPS) regime: import of ketamine as a psychotropic substance is prohibited except on production of an import certificate issued by the Narcotics Commissioner, under Rule 53 of the NDPS Rules. Directorate General of Foreign Trade (DGFT) import policy controls apply concurrently, and mandatory drug-registration and batch-release documents must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3004 90 96

Chapter

30 · Pharmaceutical products

Primary regulator

NDPS · Rule 53 of the NDPS Rules (import certificate from Narcotics Commissioner)

Customs documentation

Import certificate from Narcotics Commissioner
Import licence for drugs from CDSCO
Registration certificate from CDSCO

Applicable Partner Government Agencies

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

NDPSNDPS·Narcotics Control Bureau

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

Compliance steps

1
Obtain an import certificate from the Narcotics Commissioner before the consignment departs the country of origin. Import of ketamine as a psychotropic substance is prohibited under Rule 53 of the NDPS Rules in the absence of this certificate; the customs proper officer will not grant out-of-charge without it.
Rule 53 of the NDPS Rules
2
Upload all mandatory drug documents in e-Sanchit at the bill of entry stage: Import Licence for Drugs (document code 9111dc), Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), and Registration Certificate (Drugs) (101dc1). The proper officer verifies each upload before out-of-charge on PGA-facilitated bills.
CBIC e-Sanchit document codes 9111dc, 0010dc, 0030dc, 0110dc, 101dc1

A word of counsel

The most common error on this tariff line is conflating the NDPS import certificate from the Narcotics Commissioner with the CDSCO drug-import licence (document code 9111dc): both are independently required and neither substitutes for the other. A consignment arriving with a current CDSCO registration and a valid batch release certificate but without the Narcotics Commissioner's import certificate will be detained at the port of entry and is liable to confiscation under the NDPS Act, regardless of the therapeutic legitimacy of the product.

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Frequently asked

Does HSN 3004 90 96 require BIS certification?

No, ketamine medicaments are not within any BIS Quality Control Order regime. Import is governed by the NDPS Rules — specifically Rule 53, which prohibits import of ketamine as a psychotropic substance without an import certificate from the Narcotics Commissioner — alongside CDSCO drug-registration requirements administered under the Drugs and Cosmetics Act, 1940.

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

Five documents must be uploaded: Import Licence for Drugs (9111dc), Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), and Registration Certificate for Drugs (101dc1); the Narcotics Commissioner's import certificate should accompany these as the NDPS-specific clearance.

Does the prohibition on oxytocin imports affect this tariff line?

The oxytocin import prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to oxytocin as a separate product, not to ketamine; however, importers should confirm the bill of entry accurately describes the product, as misclassification between pharmaceutical sub-lines under heading 3004 can trigger enforcement under both the NDPS Rules and DGFT policy.

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