Placebos and blinded (or double- blinded) clinical trial kits for a recognised clinical trial, put up in measured doses
Placebos and blinded clinical trial kits, measured doses
HSN 3006 93 00 (placebos and blinded clinical trial kits) is subject to Animal Quarantine and Certification Services (AQCS) clearance under the provisions governing animal-origin veterinary health certification at the bill of entry. A veterinary health certificate issued by the exporting country and a laboratory report or Certificate of Analysis are mandatory documents to be uploaded in e-Sanchit before out-of-charge.
- Veterinary health certificate from AQCS
- Certificate of Analysis from AQCS
- Laboratory report from exporting country
- 1Obtain a veterinary health certificate issued by the competent authority of the exporting country and upload it in e-Sanchit under document code 853AQ1 before filing the bill of entry. This requirement applies to CTIs listed in Annexure A (Sl. No. 1) of CBIC Circular 24/2022-Cus dated 28-11-2022.CBIC Circular 24/2022-Cus dated 28-11-2022 · Annexure A, Sl. No. 1 · document code 853AQ1
- 2Upload the laboratory report or Certificate of Analysis (COA) in e-Sanchit under document code 001AQ1 before customs out-of-charge. This requirement applies to CTIs listed in Annexure A (Sl. No. 2) of CBIC Circular 24/2022-Cus dated 28-11-2022.CBIC Circular 24/2022-Cus dated 28-11-2022 · Annexure A, Sl. No. 2 · document code 001AQ1
The most common error on this tariff line is treating clinical trial kits as purely pharmaceutical goods subject only to drug-import clearances and overlooking the AQCS veterinary health certification overlay — which attaches because the formulation or kit component may contain animal-origin ingredients. Consignments arriving without the veterinary health certificate (853AQ1) or the COA (001AQ1) uploaded in e-Sanchit are detained at port pending PGA clearance, directly generating demurrage and ground rent during the trial timeline.