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Other

Mixed medicaments for therapeutic or prophylactic use, bulk

MOHFW CLEARANCE · AQCS CLEARANCE

HSN 3003 90 90 (Other mixed medicaments, bulk) is subject to Ministry of Health and Family Welfare (MOHFW) import licensing and drug registration controls under the Drugs and Cosmetics Act, 1940. Animal Quarantine and Certification Services (AQCS) veterinary health certificate and laboratory report requirements apply as concurrent overlays for animal-origin pharmaceutical inputs. Import of chloramphenicol and nitrofurans formulations intended for food-producing animal rearing is prohibited with effect from S.O. 1158(E) dated 12-03-2025.

What this is
HSN code
3003 90 90
Chapter
30 · Pharmaceutical products
Primary regulator
MOHFW · Drugs and Cosmetics Act, 1940 (import licence and drug registration)
Customs documentation
  • Import licence from MOHFW
  • Registration certificate from MOHFW
  • Veterinary Health Certificate from AQCS
Applicable Partner Government Agencies
MOHFWMOHFW·Ministry of Health and Family Welfare
AQCSAQCS·Animal Quarantine and Certification Services
Compliance steps
  1. 1
    Secure a valid import licence for drugs (document code 9111dc) and a drug registration certificate (document code 101dc1) under the Drugs and Cosmetics Act, 1940, and upload both in e-Sanchit before filing the bill of entry. Also upload the Certificate of Analysis (document code 0010dc), batch release certificate (document code 0030dc), and label of consignment (document code 0110dc) prior to out-of-charge.
    Drugs and Cosmetics Act, 1940 · document codes 9111dc, 101dc1, 0010dc, 0030dc, 0110dc
  2. 2
    Where the medicament is of animal origin or involves animal-derived constituents, upload the veterinary health certificate issued by the competent authority of the exporting country (document code 853AQ1) and the laboratory report or Certificate of Analysis (document code 001AQ1) in e-Sanchit, as required under Circular No. 24/2022-Cus dated 28-11-2022, Annexure A (Sl. No. 1 and Sl. No. 2).
    CBIC Circular 24/2022-Cus dated 28-11-2022 · document codes 853AQ1, 001AQ1
  3. 3
    Confirm that the medicament does not contain chloramphenicol, its formulations, nitrofurans, or their formulations intended for use in any food-producing animal rearing system. Such imports are prohibited with immediate effect, and consignments in violation are subject to confiscation.
    S.O. 1158(E) dated 12-03-2025 issued by Ministry of Health and Family Welfare
A word of counsel

The most common error on this tariff line is treating the MOHFW import licence as the sole clearance requirement and overlooking the AQCS overlay for animal-origin constituents. Where even one ingredient is of animal origin, both the veterinary health certificate (853AQ1) and the laboratory COA (001AQ1) must be uploaded in e-Sanchit independently of the drug-licence documents; a missing AQCS document holds the bill of entry in PGA-pending status regardless of the completeness of the MOHFW file.

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Frequently asked
Does HSN 3003 90 90 require BIS certification?
No, bulk mixed medicaments are not within the BIS Quality Control Order regime. Import is governed by the Ministry of Health and Family Welfare under the Drugs and Cosmetics Act, 1940, with a concurrent Animal Quarantine and Certification Services overlay for animal-origin pharmaceutical inputs.
Which document codes must be uploaded in e-Sanchit at the bill of entry for HSN 3003 90 90?
The mandatory documents are: import licence for drugs (9111dc), registration certificate for drugs (101dc1), Certificate of Analysis (0010dc), batch release certificate (0030dc), label of consignment (0110dc), health certificate (6360AQ), and — where animal origin applies — veterinary health certificate (853AQ1) and laboratory COA (001AQ1) per CBIC Circular 24/2022-Cus.
Is the prohibition on chloramphenicol and nitrofurans formulations an absolute ban or does it apply only in specific contexts?
The prohibition under S.O. 1158(E) dated 12-03-2025 is limited to use in any food-producing animal rearing system; imports for other therapeutic or prophylactic uses remain subject to the standard MOHFW licensing and drug-registration regime rather than an outright prohibition.
Last verified against gazette notifications: 2026-05-16. Source: MOHFW / AQCS / Indian Customs CUSDATA.
Related
ChapterChapter 30 · Pharmaceutical productsHSNMEDICAMENTS (EXCLUDING GOODS OF HEADING 3002, 3005 OR 3006) CONSISTING OF TWO OR MORE CONSTITUENTS WHICH HAVE BEEN MIXED TOGETHER FOR THERAPEUTIC OR PROPHYLACTIC USES, NOT PUT UP IN MEASURED DOSES OR IN FORMS OR PACKINGS FOR RETAIL SALEHSNOther :