Chloropheniramine maleate

Chloropheniramine maleate, antihistamine pharmaceutical intermediate

HSN 2933 39 14 (Chloropheniramine maleate) is subject to Central Insecticides Board and Registration Committee (CIB&RC) registration and import permit requirements under the Insecticides Act, 1968, read with Rule 45 of the Insecticides Rules, 1971, where the substance figures in the Schedule to that Act. Narcotic Drugs and Psychotropic Substances (NDPS) controls under Chapter VII-A of the NDPS Rules, 1985 apply as a concurrent overlay, and Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 governs the import policy status.

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.

1. 1
   Where chloropheniramine maleate falls within the Schedule to the Insecticides Act, 1968, obtain registration and an import permit from the Secretariat of the Central Insecticides Board and Registration Committee before shipment. The consignment must enter only through ports specified under Rule 45 of the Insecticides Rules, 1971; diversion to an unspecified port renders the import unlawful.
   Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition 2, Chapter 29
2. 2
   If the substance is imported for medical or scientific purposes under the NDPS regime, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 from the Central Bureau of Narcotics (cbn.nic.in) prior to dispatch. Imports falling outside that 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, Chapter 29
3. 3
   At the bill of entry, upload in e-Sanchit the mandatory documents: certificate of analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). Ensure the bill of entry declaration includes the Chapter 29 mandatory additional qualifiers as stipulated in Para 4.1 and 4.2 of CBIC Circular 23/2023-Cus dated 30-09-2023, effective 15 October 2023.
   CBIC Circular 23/2023-Cus dated 30-09-2023 · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc