Methyl dopa (1-alpha methyl-3, 4-dihydroxyphenylaniline)

Methyldopa, an aniline derivative antihypertensive active pharmaceutical ingredient

HSN 2921 42 36 (Methyldopa) is subject to Central Insecticides Board and Registration Committee (CIB&RC) registration and import permit under the Insecticides Act, 1968, where the substance falls within the Schedule to that Act, and to Narcotic Drugs and Psychotropic Substances (NDPS) import certificate requirements under Chapter VII-A of the NDPS Rules, 1985. The Directorate General of Foreign Trade (DGFT) ITC (HS) policy conditions, including Chemical Weapons Convention obligations for scheduled precursors, and Central Board of Indirect Taxes and Customs (CBIC) Chapter 29 mandatory qualifier declarations under CBIC Circular 23/2023-Cus apply as additional clearance requirements.

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

1. 1
   If the substance 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 filing the bill of entry. Import is permitted only at restricted places of import under Rule 45 of the Insecticides Rules, 1971; route the consignment accordingly.
   Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition for Chapter 29
2. 2
   Where the consignment is classified as an NDPS substance, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 before shipment; imports for medical and scientific purposes are processed under Chapter VII-A of those Rules via the Narcotics Commissioner (cbn.nic.in). Imports outside the medical/scientific category are governed by Appendix I to the ITC (HS) Schedule per ITC (HS) policy condition 2 to Chapter 29.
   Rule 53 of the NDPS Rules, 1985 · Chapter VII-A of the NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
3. 3
   Upload mandatory documents in e-Sanchit 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). Ensure the bill of entry carries 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.
   CBIC Circular 23/2023-Cus dated 30-09-2023 · e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc