Analgin with or without other compounds such as paracetamol
Analgin medicaments with or without paracetamol
HSN 3004 90 61 (Analgin with or without other compounds such as paracetamol) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing requirements under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies import under this tariff line as subject to policy conditions, and mandatory e-Sanchit documentation — including a Certificate of Analysis, batch release certificate, and registration certificate — must be uploaded before customs out-of-charge.
- Registration certificate from CDSCO
- Import licence from CDSCO
- Certificate of Analysis from manufacturer
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.
- 1Obtain a valid drug registration certificate and import licence for drugs from the Central Drugs Standard Control Organisation before filing the bill of entry. Upload the registration certificate (document code 101dc1) and import licence for drugs (document code 9111dc) in e-Sanchit; customs out-of-charge will not be granted until both documents are verified.Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
- 2Upload the Certificate of Analysis for drugs (document code 0010dc), the batch release certificate (document code 0030dc), and the label of consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer must verify all five mandatory document codes before granting out-of-charge on PGA-facilitated bills.e-Sanchit document codes 0010dc, 0030dc, 0110dc
- 3Note that import of oxytocin is prohibited under this heading; only oxytocin reference standards for test and analysis purposes are permitted, subject to submission of a test licence issued by the DGCI/CDSCO.S.O. 2357(E) · DGFT Notification 09/2015-2020, both dated 23-05-2022
The most common error on this tariff line is treating CDSCO drug registration and the import licence as interchangeable — they are distinct documents with separate document codes (101dc1 and 9111dc respectively) and both must be independently uploaded in e-Sanchit. A bill of entry that carries one but not the other will be detained at the customs station pending document rectification, accruing demurrage and ground rent; the batch release certificate (0030dc) is equally mandatory and is frequently omitted by importers accustomed to less-regulated pharmaceutical lines.