Cimetidine
Cimetidine, organic compound for pharmaceutical use
HSN 2942 00 32 (Cimetidine) is subject to drug-registration and import-licence requirements enforced through the mandatory e-Sanchit document set under the Drugs and Cosmetics Act, 1940, with a concurrent Narcotic Drugs and Psychotropic Substances (NDPS) overlay where the substance is imported for medical or scientific purposes under Chapter VII-A of the NDPS Rules, 1985. Items falling under this CTI that figure in the Schedule to the Insecticides Act, 1968 additionally require registration and import permit from the Central Insecticides Board and Registration Committee (CIB&RC). DGFT policy condition 2 to Chapter 29 and CBIC Circular 23/2023-Cus mandatory Chapter 29 qualifiers apply as further customs-level overlays.
- Import certificate from NDPS authority
- Registration certificate from CDSCO
- Import licence for drugs from CDSCO
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.
- 1Where the consignment is imported for medical or scientific purposes, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 before shipment. For imports not falling under the medical/scientific category, verify compliance with Appendix-I to the ITC (HS) Schedule per ITC (HS) policy condition 2 to Chapter 29.NDPS Rules, 1985, Rule 53 and Chapter VII-A · ITC (HS) policy condition 2 to Chapter 29
- 2Upload the complete mandatory drug-document set in e-Sanchit before the bill of entry is given out-of-charge: Certificate of Analysis – Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate – Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer must verify all five codes are present in e-Sanchit before granting OOC.CCR e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
- 3Ensure the import declaration includes the mandatory additional qualifiers for Chapter 29 commodities as stipulated in paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus, effective 15 October 2023. If the substance also falls under the Schedule to the Insecticides Act, 1968, obtain registration and an import permit from the secretariat of CIB&RC and route the consignment through a port notified under Rule 45 of the Insecticides Rules, 1971.CBIC Circular 23/2023-Cus dated 30-09-2023, paras 4.1 and 4.2 · Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971
The most common error on this tariff line is filing the bill of entry with the drug-document set complete but omitting the Chapter 29 mandatory qualifiers required by CBIC Circular 23/2023-Cus — an omission that triggers misdeclaration proceedings independent of any PGA clearance deficiency. Additionally, importers assume the NDPS medical/scientific import certificate and the drug-import licence are the same instrument; they are not, and a consignment presented with only one of the five mandatory e-Sanchit document codes will be detained at the port until all codes are uploaded, accruing demurrage.