Calcium gluconate

Calcium gluconate, gluconic acid salt for medical use

CIB&RC CLEARANCE · NDPS CLEARANCE

HSN 2918 16 10 (Calcium gluconate) is subject to Central Insecticides Board and Registration Committee (CIB&RC) registration and import permit under the Insecticides Act, 1968 where the substance figures in the Schedule to that Act, with import restricted to notified places under Rule 45 of the Insecticides Rules, 1971. Narcotic Drugs and Psychotropic Substances (NDPS) controls under Chapter VII-A of the NDPS Rules, 1985 and the Directorate General of Foreign Trade (DGFT) ITC (HS) Policy Condition 2 of Chapter 29 apply as additional overlays, alongside mandatory Chapter 29 qualifier declarations under CBIC Circular 23/2023-Cus.

What this is

HSN code

2918 16 10

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
Chapter 29 qualifiers from CBIC

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
Verify whether the specific formulation of calcium gluconate being imported figures in the Schedule to the Insecticides Act, 1968. If it does, obtain registration and an import permit from the Secretariat of the Central Insecticides Board and Registration Committee, and route the consignment only through notified places of import per Rule 45 of the Insecticides Rules, 1971.
Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971
2
Upload the mandatory e-Sanchit documents before filing the bill of entry: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc). Non-upload delays out-of-charge and attracts consignment detention.
CCR mandatory-document list for CTI 2918 16 10 · CBIC e-Sanchit protocol
3
Comply with CBIC Circular 23/2023-Cus dated 30-09-2023 by providing mandatory additional qualifiers in the import declaration for Chapter 29 commodities, as stipulated in paragraphs 4.1 and 4.2, with effect from 15 October 2023. Declarations missing the required qualifiers are liable to detention at the customs station.
CBIC Circular 23/2023-Cus dated 30-09-2023, paragraphs 4.1 and 4.2

A word of counsel

The most frequent compliance failure on this tariff line is assuming calcium gluconate is invariably outside the Insecticides Act, 1968 Schedule because its primary commercial use is nutritional or pharmaceutical. Whether CIB&RC registration and a restricted-port import permit are triggered depends entirely on whether the specific formulation is listed in that Schedule — and that determination must be made product-by-product, not by analogy. An importer who ships to an unnotified port without CIB&RC permit, even with valid drug-registration documents, faces seizure under the Insecticides Act independently of any CDSCO or NDPS clearance.

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Frequently asked

Does HSN 2918 16 10 require BIS certification?

No. Calcium gluconate is not covered by any BIS Quality Control Order. Import is governed primarily by the Central Insecticides Board and Registration Committee under the Insecticides Act, 1968 where the substance is Schedule-listed, with NDPS Rules, 1985 controls and DGFT ITC (HS) Policy Condition 2 of Chapter 29 as additional overlays.

Which document codes must be uploaded in e-Sanchit 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 to be uploaded before out-of-charge is granted.

When do NDPS Rules, 1985 controls apply to a calcium gluconate import?

NDPS controls apply where the substance or its derivative falls within the NDPS schedule; such imports require an import certificate under Rule 53 of the NDPS Rules, 1985 for medical and scientific purposes per Chapter VII-A, while other imports are governed by Appendix I to the ITC (HS) Schedule per DGFT Policy Condition 2 of Chapter 29.

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