Metronidazole, metronidiazole benzoate
Metronidazole and metronidazole benzoate active pharmaceutical ingredients
HSN 2933 29 20 (Metronidazole, metronidazole benzoate) is subject to drug import controls requiring a Registration Certificate and Import Licence for drugs uploaded in e-Sanchit under the Drugs and Cosmetics Act, 1940. The Central Insecticides Board and Registration Committee (CIB&RC) registration and import permit apply where the substance falls within the Schedule to the Insecticides Act, 1968, and NDPS chapter VII-A import-certificate conditions govern any psychotropic-substance overlay under the NDPS Rules, 1985.
- Registration certificate from CIB&RC
- Import Licence for drugs from CDSCO
- Import certificate from NDPS
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, confirm whether the consignment falls within the Schedule to the Insecticides Act, 1968. If so, obtain registration and an import permit from the Central Insecticides Board and Registration Committee; import is restricted to notified ports only under Rule 45 of the Insecticides Rules, 1971.Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition 2 to Chapter 29
- 2Upload all mandatory drug-import documents in e-Sanchit before out-of-charge: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc). Where the substance is subject to NDPS chapter VII-A, an import certificate under Rule 53 of the NDPS Rules, 1985 is also required.NDPS Rules, 1985, Rule 53 and Chapter VII-A · ITC (HS) policy condition 2 to Chapter 29
- 3Include mandatory Chapter 29 additional qualifiers in the import declaration as stipulated in paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus dated 30-09-2023, effective 15 October 2023. Non-compliance results in the bill of entry being flagged for mismatch, causing detention and demurrage.CBIC Circular 23/2023-Cus dated 30-09-2023
The most common error on this tariff line is filing the drug-import documents (101dc1, 9111dc) without first assessing whether the specific formulation also triggers CIB&RC registration as a pesticide under the Insecticides Act, 1968. Metronidazole-based substances can straddle the drug and insecticide schedules simultaneously; an importer who satisfies drug-import clearance but bypasses CIB&RC registration faces consignment seizure and prosecution under Section 17 of the Insecticides Act, 1968, independently of any Drugs and Cosmetics Act liability.