Sulphadiazine

Sulphadiazine sulphonamide active pharmaceutical ingredient

CIB&RC CLEARANCE · NDPS CLEARANCE

HSN 2935 90 13 (Sulphadiazine) is subject to registration and import permit requirements of the Central Insecticides Board and Registration Committee (CIB&RC) under the Insecticides Act, 1968, where the substance figures in the Schedule to that Act, and to Narcotic Drugs and Psychotropic Substances (NDPS) import-certificate conditions under Rule 53 of the NDPS Rules, 1985. A Minimum Import Price of ₹1,774 per kg applies to Sulphadiazine API until 30 September 2026 under DGFT Notification 41/2025-26, and mandatory Chapter 29 additional qualifiers under CBIC Circular 23/2023-Cus apply at the bill-of-entry stage.

What this is

HSN code

2935 90 13

Chapter

29 · Organic chemicals

Primary regulator

CIB&RC · Insecticides Act, 1968 and Insecticides Rules, 1971

Customs documentation

Registration certificate from CIB&RC
Import permit from CIB&RC
Import certificate from NDPS

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 registration and an import permit from the secretariat of the Central Insecticides Board and Registration Committee if Sulphadiazine falls within the Schedule to the Insecticides Act, 1968. Import is restricted to places notified under Rule 45 of the Insecticides Rules, 1971; routing through an un-notified port renders the consignment liable to seizure.
Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy
2
Where the substance is subject to NDPS conditions, secure an import certificate under Rule 53 of the NDPS Rules, 1985 before shipment. Imports not qualifying under Chapter VII-A of the NDPS Rules for medical and scientific purposes are governed by Appendix-I to the ITC (HS) Schedule per policy condition 2 of Chapter 29.
Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
3
At the bill of entry, upload in e-Sanchit the certificate of analysis (document code 0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). Confirm that CIF value meets or exceeds ₹1,774 per kg unless the consignment qualifies for the AA/EOU/SEZ MIP exemption with a documented no-DTA-sale undertaking. Apply mandatory Chapter 29 additional qualifiers per CBIC Circular 23/2023-Cus paragraphs 4.1 and 4.2.
DGFT Notification 41/2025-26 dated 10-10-2025 · CBIC Circular 23/2023-Cus dated 30-09-2023

A word of counsel

The most frequent error on this tariff line is treating the general 'Free' import status as unconditional — Sulphadiazine API carries a Minimum Import Price of ₹1,774 per kg operative until 30 September 2026, and an MIP-deficient consignment is treated as Restricted-import non-compliance regardless of the NDPS or CIB&RC clearances being in order. Additionally, the Public Liability Insurance obligation under S.O. 227(E) dated 24-03-1992 is frequently overlooked where consignment quantities exceed the specified threshold for hazardous substances.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 2935 90 13 require BIS certification?

No, sulphonamide active pharmaceutical ingredients are not within the BIS Quality Control Order regime. Import is governed by the Central Insecticides Board and Registration Committee under the Insecticides Act, 1968, with concurrent NDPS import-certificate conditions under Rule 53 of the NDPS Rules, 1985, and a DGFT-administered Minimum Import Price condition until 30 September 2026.

Which document codes are mandatory in e-Sanchit for this tariff line?

Five documents must be uploaded before out-of-charge: certificate of analysis (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc), as required under the PGA-facilitated bill-of-entry verification process.

Does the MIP exemption for AA/EOU/SEZ units apply automatically?

No. The exemption from the ₹1,774 per kg MIP condition for Advance Authorisation holders, Export Oriented Units, and SEZ units is conditional on the imported inputs not being sold into the Domestic Tariff Area; a subsequent DTA diversion converts the original import into a Restricted-policy breach attracting retrospective duty and DGFT enforcement.

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