Cysteanune HCl
Cysteamine hydrochloride, organic chemical compound
HSN 2942 00 26 (Cysteamine HCl) is subject to dual primary-regulator oversight: the Central Insecticides Board and Registration Committee (CIB&RC) requires registration and an import permit if the substance figures in the Schedule to the Insecticides Act, 1968, and the Narcotic Drugs and Psychotropic Substances (NDPS) framework requires an import certificate under Rule 53 of the NDPS Rules, 1985 for medical and scientific purposes. The Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 and Central Board of Indirect Taxes and Customs (CBIC) Circular 23/2023-Cus dated 30-09-2023 apply as additional customs-level overlays.
- Registration certificate from CIB&RC
- Import certificate from NDPS
- Import licence from CDSCO
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.
- 1Determine whether the consignment falls within the Schedule to the Insecticides Act, 1968. If so, obtain registration and an import permit from the Secretariat of the Central Insecticides Board and Registration Committee before shipment, and note that the places at which insecticides may be imported are restricted under Rule 45 of the Insecticides Rules, 1971.Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition 2 of Chapter 29
- 2If the substance is being imported for medical or scientific purposes under the NDPS framework, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 before filing the bill of entry. Imports outside the medical and scientific purpose category are governed by Appendix-I to the ITC (HS) Schedule.Chapter VII-A and Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 of Chapter 29
- 3Upload all mandatory e-Sanchit documents before 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). Also ensure mandatory Chapter 29 additional qualifiers are declared in the import entry per CBIC Circular 23/2023-Cus with effect from 15-10-2023.CBIC Circular 23/2023-Cus dated 30-09-2023 · Para 4.1 and 4.2 of the said Circular
The most common error on this tariff line is failing to resolve the CIB&RC-versus-NDPS applicability question before filing the bill of entry. These are independent statutory regimes with different issuing authorities and document sets; a consignment that satisfies the NDPS import certificate requirement but lacks the CIB&RC registration will be detained at the port of import pending PGA NOC verification. Additionally, importers exceeding the specified quantities of hazardous substances must hold an insurance policy under the Public Liability Insurance Act, 1991 per S.O. 227(E) dated 24-03-1992 — an obligation frequently overlooked in the drug-compliance track.