Ethambutol, ethambutol Hcl

Ethambutol and ethambutol hydrochloride, pharmaceutical grade

CIB&RC CLEARANCE · NDPS CLEARANCE

HSN 2905 14 10 (Ethambutol, ethambutol HCl) is subject to dual primary-regulator oversight: the Narcotic Drugs and Psychotropic Substances (NDPS) import-certificate regime under Chapter VII-A of the NDPS Rules, 1985, and Central Insecticides Board and Registration Committee (CIB&RC) registration and import-permit requirements where the substance falls within the Schedule to the Insecticides Act, 1968. DGFT policy condition 2 of Chapter 29 governs non-medical/scientific NDPS imports, and mandatory Chapter 29 chemical qualifiers under CBIC Circular 23/2023-Cus apply at the bill-of-entry stage.

What this is

HSN code

2905 14 10

Chapter

29 · Organic chemicals

Primary regulator

NDPS · NDPS Rules, 1985 (Chapter VII-A); CIB&RC · Insecticides Act, 1968

Customs documentation

Import certificate from NDPS
Registration certificate from CIB&RC
Import licence for drugs from CDSCO

Applicable Partner Government Agencies

CIB&RCCIB&RC·Central Insecticides Board and Registration Committee

NDPSNDPS·Narcotics Control Bureau

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.

Compliance steps

1
For imports under the medical and scientific purposes track, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 from the Central Bureau of Narcotics before shipment. Confirm the import certificate is uploaded in e-Sanchit alongside the drug-import document set — certificate of analysis (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) — before the bill of entry is filed.
Chapter VII-A and Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 of Chapter 29 · CBIC e-Sanchit mandatory document requirement
2
Where the substance falls within the Schedule to the Insecticides Act, 1968, obtain registration and an import permit from the Secretariat of the Central Insecticides Board and Registration Committee. Import is further restricted to notified places under Rule 45 of the Insecticides Rules, 1971; route the consignment accordingly and upload the CIB&RC registration certificate before out-of-charge.
Insecticides Act, 1968 (Schedule) · Rule 45 of the Insecticides Rules, 1971
3
Include mandatory additional qualifiers in the import declaration for Chapter 29 commodities as stipulated in paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus. These qualifiers are mandatory with effect from 15 October 2023 and their absence renders the bill of entry non-compliant at the customs system level. Where the consignment exceeds the threshold quantities for hazardous substances, obtain an insurance policy under the Public Liability Insurance Act, 1991 per S.O. 227(E) dated 24-03-1992.
CBIC Circular 23/2023-Cus dated 30-09-2023 · S.O. 227(E) dated 24-03-1992

A word of counsel

The most common error on this tariff line is treating the drug-document set (registration certificate 101dc1, import licence 9111dc) as the complete clearance requirement and overlooking the independent NDPS import-certificate obligation under Rule 53. The two regimes are parallel and neither satisfies the other: a valid drug import licence does not substitute for the Central Bureau of Narcotics import certificate, and a missing NDPS certificate will result in detention and ground rent accruing while the Narcotics Commissioner's clearance is retrospectively sought.

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Frequently asked

Does HSN 2905 14 10 require BIS certification?

No. No BIS Quality Control Order covers ethambutol or its hydrochloride salt. Import is governed by the NDPS Rules, 1985 for the narcotics-controlled track and the Insecticides Act, 1968 where the substance appears in the Insecticides Schedule, with DGFT policy condition 2 of Chapter 29 applying to non-medical and non-scientific imports.

Which e-Sanchit document codes are mandatory for the drug-import track at the bill of entry?

Five documents must be uploaded in e-Sanchit before out-of-charge is granted: certificate of analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc).

When does the Insecticides Act, 1968 overlay apply, and what happens if CIB&RC registration is absent?

The overlay applies if the specific ethambutol formulation or preparation appears in the Schedule to the Insecticides Act, 1968; importers should verify Schedule coverage with CIB&RC before purchase order placement. Arrival without CIB&RC registration and a valid import permit at a non-notified port constitutes a violation of Rule 45 of the Insecticides Rules, 1971, exposing the consignment to seizure and the importer to prosecution under the Act.

Last verified against gazette notifications: 2026-05-16. Source: CIB&RC / NDPS / DGFT / CBIC / Indian Customs CUSDATA.