6-APA
6-APA, penicillanic acid structure antibiotic intermediate
HSN 2941 10 50 (6-APA) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) import controls under Chapter VII-A of the NDPS Rules, 1985, requiring an import certificate under Rule 53 before the consignment may enter India. Imports not qualifying for the medical and scientific purposes category are governed by Appendix-I of the ITC (HS) Schedule under DGFT policy condition 2 of Chapter 29, with mandatory Chapter 29 qualifiers in the customs declaration required by the Central Board of Indirect Taxes and Customs (CBIC) under Circular 23/2023-Cus.
- Import certificate from NDPS
- Import licence for drugs from CDSCO
- Registration certificate from CDSCO
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.
- 1Obtain an import certificate under Rule 53 of the NDPS Rules, 1985 from the Central Bureau of Narcotics (cbn.nic.in) before shipment. This certificate is the primary NDPS clearance and must be uploaded in e-Sanchit along with the registration certificate for drugs (document code 101dc1) and the import licence for drugs (document code 9111dc).Rule 53 and Chapter VII-A of the NDPS Rules, 1985; DGFT ITC (HS) policy condition 2 of Chapter 29
- 2Upload all mandatory documents in e-Sanchit before the bill of entry is out-of-charged: certificate of analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). The proper officer will verify each document code before granting out-of-charge.CCR e-Sanchit document requirements; CBIC Circular 23/2023-Cus dated 30-09-2023
- 3Include mandatory additional qualifiers in the import declaration for Chapter 29 commodities as stipulated in paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus, effective 15 October 2023. Declarations filed without the requisite Chapter 29 qualifiers will be held at the port pending amendment.CBIC Circular 23/2023-Cus dated 30-09-2023, paragraphs 4.1 and 4.2
The most common error on this tariff line is assuming that possession of a drug registration certificate and import licence satisfies the full pre-import requirement — overlooking the separate NDPS import certificate under Rule 53, which must be obtained from the Central Bureau of Narcotics independently of any CDSCO drug-licensing process. Without the Rule 53 certificate, the consignment is liable to seizure under the Narcotic Drugs and Psychotropic Substances Act, 1985 irrespective of CDSCO clearance status; the two regulatory tracks run in parallel and neither substitutes for the other.