Ranitidine

Ranitidine, other organic pharmaceutical compound

CIB&RC CLEARANCE · NDPS CLEARANCE

HSN 2942 00 14 (Ranitidine) is subject to drug import controls requiring a Registration Certificate and Import Licence under the Drugs and Cosmetics Act, 1940, administered by the Central Drugs Standard Control Organisation at the bill-of-entry stage. The Narcotic Drugs and Psychotropic Substances (NDPS) regime under Chapter VII-A of the NDPS Rules, 1985 applies as a concurrent overlay where the substance is categorised under the NDPS schedule, and items falling within the schedule to the Insecticides Act, 1968 additionally require registration and import permit from the Central Insecticides Board and Registration Committee (CIB&RC).

What this is

HSN code

2942 00 14

Chapter

29 · Organic chemicals

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
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 a Registration Certificate for drugs (document code 101dc1) and an Import Licence for drugs (document code 9111dc) from the drug regulatory authority before filing the bill of entry. Confirm also that the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) are all uploaded in e-Sanchit prior to customs out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc
2
If the substance figures in the schedule to the Insecticides Act, 1968, obtain registration and an import permit from the Secretariat of CIB&RC. Import is also restricted to specified ports under Rule 45 of the Insecticides Rules, 1971; verify the permitted ports before routing the consignment.
Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition 2 to Chapter 29
3
Ensure all import declarations include mandatory additional qualifiers for Chapter 29 commodities as stipulated in Paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus dated 30-09-2023, effective 15 October 2023. Where the substance is classified under the NDPS schedule, an import certificate under Rule 53 of the NDPS Rules, 1985 is required before the bill of entry is filed.
CBIC Circular 23/2023-Cus dated 30-09-2023 · Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29

A word of counsel

The most common error on this tariff line is assuming that a current drug Registration Certificate and Import Licence satisfy all clearance requirements, without investigating whether the specific batch of Ranitidine also triggers the NDPS import-certificate requirement under Rule 53 of the NDPS Rules, 1985 or the CIB&RC permit requirement under the Insecticides Act, 1968. Either omission results in detention at the port of import and potential confiscation; the NDPS overlay in particular carries criminal liability under the NDPS Act, 1985 for non-compliance.

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Frequently asked

Does HSN 2942 00 14 require BIS certification?

No, no BIS Quality Control Order covers Ranitidine or other organic pharmaceutical compounds. Import is governed by drug registration and licensing controls under the Drugs and Cosmetics Act, 1940, with concurrent NDPS and CIB&RC overlays where the substance falls within the respective schedules.

Which document codes must be uploaded in e-Sanchit for Ranitidine imports?

The mandatory uploads are: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc); all must be present before customs out-of-charge.

Does the NDPS import certificate under Rule 53 apply to every Ranitidine consignment?

Only where the specific substance or preparation is categorised under the NDPS schedule; imports for medical and scientific purposes are permitted under Chapter VII-A of the NDPS Rules, 1985 after obtaining the Rule 53 certificate, while other imports are governed by Appendix-I to the ITC (HS) Schedule per policy condition 2 of Chapter 29.

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