Nifedipine

Nifedipine, a calcium channel blocker organic compound

CIB&RC CLEARANCE · NDPS CLEARANCE

HSN 2942 00 13 (Nifedipine) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) import controls under Chapter VII-A of the NDPS Rules, 1985, requiring an import certificate under Rule 53 before the bill of entry is filed. Imports falling within the Schedule to the Insecticides Act, 1968 additionally require registration and a permit from the Central Insecticides Board and Registration Committee (CIB&RC) under Rule 45 of the Insecticides Rules, 1971. Mandatory Chapter 29 additional qualifiers under CBIC Circular 23/2023-Cus and ITC (HS) policy condition 2 to Chapter 29 administered by the Directorate General of Foreign Trade (DGFT) apply as customs-policy overlays.

What this is

HSN code

2942 00 13

Chapter

29 · Organic chemicals

Primary regulator

NDPS · NDPS Rules, 1985, Chapter VII-A (medical and scientific import regime)

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 for medical or scientific purpose imports. For imports outside the medical/scientific category, compliance with Appendix-I to the ITC (HS) Schedule under ITC (HS) policy condition 2 to Chapter 29 is mandatory.
Chapter VII-A of the NDPS Rules, 1985 · Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
2
If the consignment falls within the Schedule to the Insecticides Act, 1968, obtain registration and an import permit from the secretariat of CIB&RC, and route the consignment only through ports specified under Rule 45 of the Insecticides Rules, 1971. Upload the mandatory documents — certificate of analysis (drug) [0010dc], batch release certificate [0030dc], label of consignment [0110dc], registration certificate (drugs) [101dc1], and import licence for drugs [9111dc] — in e-Sanchit before out-of-charge.
Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Ensure the import declaration includes mandatory additional qualifiers for Chapter 29 commodities as stipulated in Paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus, with effect from 15 October 2023. Additionally, if import quantities of specified hazardous substances exceed prescribed thresholds, 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 nifedipine exclusively as a pharmaceutical and overlooking the dual-regime trap: the NDPS import certificate governs the narcotic/psychotropic overlay while a separate CIB&RC registration and port restriction applies if the substance also figures in the Schedule to the Insecticides Act, 1968. Arrival at a non-notified port without a valid CIB&RC permit — even where the NDPS certificate is current — exposes the consignment to detention and seizure under the Insecticides Rules, 1971.

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Frequently asked

Does HSN 2942 00 13 require BIS certification?

No. No BIS Quality Control Order covers this organic compound. Import of nifedipine is governed by the NDPS Rules, 1985 under Chapter VII-A for medical and scientific purposes, with an additional CIB&RC registration and permit requirement where the substance falls within the Schedule to the Insecticides Act, 1968.

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

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

What happens if nifedipine is imported for purposes other than medical or scientific use?

Imports outside the medical and scientific category are governed by Appendix-I to the ITC (HS) Schedule under ITC (HS) policy condition 2 to Chapter 29, and non-compliance renders the consignment liable to confiscation and monetary penalty under the Customs Act, 1962.

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