Metroprolol tartrate
Metoprolol tartrate, a beta-blocker active pharmaceutical ingredient
HSN 2918 13 20 (Metoprolol tartrate) is subject to drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit documentation verified by the Central Board of Indirect Taxes and Customs (CBIC). Items under this tariff line may also fall within the Schedule to the Insecticides Act, 1968, requiring registration and an import permit from the Central Insecticides Board and Registration Committee (CIB&RC), and the line carries an Narcotic Drugs and Psychotropic Substances (NDPS) overlay for any scheduled substances imported for medical or scientific purposes.
- Registration certificate from CDSCO
- Import licence for drugs from CDSCO
- Certificate of analysis from exporter
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.
- 1Before filing the bill of entry, ensure the drug registration certificate (document code 101dc1) and the import licence for drugs (document code 9111dc) are uploaded in e-Sanchit. The proper officer will verify that the batch release certificate (0030dc), certificate of analysis (0010dc), and label of consignment (0110dc) are also uploaded before granting out-of-charge.CBIC CCR e-Sanchit document codes 101dc1, 9111dc, 0030dc, 0010dc, 0110dc
- 2If the consignment contains a substance scheduled under the Insecticides Act, 1968, obtain registration and an import permit from the Central Insecticides Board and Registration Committee. Import is restricted to notified places of import only, per Rule 45 of the Insecticides Rules, 1971.Insecticides Act, 1968 · Rule 45, Insecticides Rules, 1971 · ITC (HS) policy condition 2 of Chapter 29
- 3Comply with CBIC Circular 23/2023-Cus dated 30-09-2023 by furnishing mandatory additional qualifiers in the import declaration for Chapter 29 commodities with effect from 15 October 2023. If the substance is an NDPS-scheduled item imported for medical or scientific purposes, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 per Chapter VII-A of those Rules.CBIC Circular 23/2023-Cus dated 30-09-2023, paras 4.1 and 4.2 · Rule 53, NDPS Rules, 1985
The most common error on this tariff line is treating metoprolol tartrate as a pure drug-regime import and overlooking the dual-schedule exposure: if a consignment's formulation or impurity profile places it within the Schedule to the Insecticides Act, 1968, a separate CIB&RC registration and permit is required independently of the drug import licence, and import is confined to notified ports under Rule 45 of the Insecticides Rules, 1971. Routing a scheduled-insecticide substance through an unnotified port — even under a valid drug licence — renders the consignment liable to detention and confiscation under the Insecticides Act.