Isoniazid

Isoniazid, organic hydrazine derivative (anti-tuberculosis drug)

CIB&RC CLEARANCE · NDPS CLEARANCE

HSN 2928 00 10 (Isoniazid) is subject to drug import licensing under the Drugs and Cosmetics Act, 1940, with mandatory registration certificate and batch release documentation required at the bill of entry. Narcotic Drugs and Psychotropic Substances (NDPS) Rules, 1985 apply as a concurrent overlay for any scheduled-substance dimension, and the Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 governs the import-policy classification. Central Board of Indirect Taxes and Customs (CBIC) Circular 23/2023-Cus dated 30-09-2023 mandates additional Chapter 29 qualifiers in all import declarations from 15 October 2023.

What this is

HSN code

2928 00 10

Chapter

29 · Organic chemicals

Primary regulator

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

Customs documentation

Import licence for drugs from CDSCO
Registration certificate from CDSCO
Batch release certificate from manufacturer

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
Obtain and upload in e-Sanchit the Import Licence for Drugs (document code 9111dc) and the Registration Certificate for Drugs (document code 101dc1) before filing the bill of entry. Also upload the Certificate of Analysis — Drug (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the Label of Consignment (document code 0110dc); the proper officer will verify all five before granting out-of-charge.
CCR mandatory-document instruction · document codes 9111dc, 101dc1, 0010dc, 0030dc, 0110dc
2
Include the mandatory Chapter 29 additional qualifiers in the import declaration as stipulated in paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus dated 30-09-2023, with effect from 15 October 2023. Declarations lacking these qualifiers are liable to be held at assessment.
CBIC Circular 23/2023-Cus dated 30-09-2023, paragraphs 4.1 and 4.2
3
If the consignment is imported for medical or scientific purposes under the NDPS overlay, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 before shipment. Imports outside the medical/scientific category are governed by Appendix-I to the ITC (HS) Schedule per ITC (HS) policy condition 2 of Chapter 29.
Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2, Chapter 29

A word of counsel

The most common error on this tariff line is treating the drug-import documentation set as complete without addressing the NDPS overlay: isoniazid's classification as an organic derivative of hydrazine places it within the scope of NDPS Rules, 1985 screening, and a bill of entry that is fully documented for drug import but carries no Rule 53 import certificate — where the substance dimension triggers that requirement — will be detained pending NDPS clearance. Additionally, the CIB&RC insecticide-registration requirement under Rule 45 of the Insecticides Rules, 1971 applies if the specific formulation falls within the Schedule to the Insecticides Act, 1968; importers should confirm classification against that Schedule before filing.

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Frequently asked

Does HSN 2928 00 10 require BIS certification?

No, organic derivatives of hydrazine including isoniazid are not within the BIS Quality Control Order regime. Import is governed by drug licensing under the Drugs and Cosmetics Act, 1940, with an NDPS Rules, 1985 overlay and the ITC (HS) policy condition 2 of Chapter 29 administered by DGFT.

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

Five documents must be uploaded: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc); out-of-charge will not be granted until all five are verified.

When does the CIB&RC registration requirement apply to this HSN?

Registration and import permit from the Central Insecticides Board and Registration Committee are required only if the specific product or formulation falls within the Schedule to the Insecticides Act, 1968; import of such items is also restricted to ports specified under Rule 45 of the Insecticides Rules, 1971.

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