Diphenoxylate hydrochloride

Diphenoxylate hydrochloride, psychotropic substance for medical use

CIB&RC CLEARANCE · NDPS CLEARANCE

HSN 2933 39 15 (Diphenoxylate hydrochloride) is subject to dual primary regulation: import for medical and scientific purposes requires an import certificate under Rule 53 of the Narcotic Drugs and Psychotropic Substances (NDPS) Rules, 1985, while any insecticidal application requires registration and an import permit from the Central Insecticides Board and Registration Committee (CIB&RC) under the Insecticides Act, 1968. The tariff line is also subject to Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 to Chapter 29 and mandatory Chapter 29 qualifiers under CBIC Circular 23/2023-Cus dated 30-09-2023.

What this is

HSN code

2933 39 15

Chapter

29 · Organic chemicals

Primary regulator

NDPS · Narcotic Drugs and Psychotropic Substances Rules, 1985 (Rule 53 import certificate)

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
Obtain an import certificate under Rule 53 of the NDPS Rules, 1985 from the Central Bureau of Narcotics before the bill of entry is filed. Imports outside the medical and scientific purposes category are governed by Appendix-I to the ITC (HS) Schedule under DGFT policy condition 2 to Chapter 29 and may be prohibited.
Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
2
Where the consignment falls within the schedule to the Insecticides Act, 1968, secure registration and an import permit from the secretariat of CIB&RC and route the consignment only through ports notified under Rule 45 of the Insecticides Rules, 1971. Upload in e-Sanchit: certificate of analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) before out-of-charge.
Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · CBIC e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Include the mandatory Chapter 29 additional qualifiers in the import declaration as required under paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus, effective 15 October 2023. Declarations deficient in these qualifiers are liable to be held for examination and may attract detention at port.
CBIC Circular 23/2023-Cus dated 30-09-2023, paragraphs 4.1 and 4.2

A word of counsel

The most common error on this tariff line is filing without the NDPS Rule 53 import certificate on the assumption that a drug registration or CDSCO import licence alone satisfies customs clearance. The NDPS certificate is an independent pre-import requirement issued by the Central Bureau of Narcotics; its absence at the bill-of-entry stage results in consignment detention regardless of the currency of any drug-licence documentation. Where the substance also triggers the Insecticides Act schedule, both the NDPS certificate and the CIB&RC permit must be present concurrently — neither substitutes for the other.

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Frequently asked

Does HSN 2933 39 15 require BIS certification?

No, diphenoxylate hydrochloride is not covered by any BIS Quality Control Order. Import is governed primarily by Rule 53 of the NDPS Rules, 1985 and, where the insecticidal schedule applies, by the Central Insecticides Board and Registration Committee under the Insecticides Act, 1968, with DGFT ITC (HS) policy condition 2 to Chapter 29 as the overarching policy overlay.

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

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

Does the Public Liability Insurance requirement apply to imports of diphenoxylate hydrochloride?

Yes, where the import of this specified hazardous substance exceeds the quantities prescribed under S.O. 227(E) dated 24-03-1992 issued by the Ministry of Environment and Forests, the owner is required to obtain a public liability insurance policy under the Public Liability Insurance Act, 1991.

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