Ketoconazole (CAS 65277-42-1): import duty, licences and trade rules in India
(2S,4R)-ketoconazole is a cis-1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine which dioxolane moiety has (2S,4R)-configuration. For trade in India: OK to trade, but watch: rules in India; global treaties & export markets; safety. Import duty is about 27.73% (tariff item 2934 (estimate)). Drug schedule: H. EU CMR classification: Repr. 1B.
Checked 2026-10-31 against official Indian and international lists. Sources are given under each answer.
Key facts
| CAS number | 65277-42-1 |
|---|---|
| Formula | C26H28Cl2N4O4 |
| Also called | Nizoral, Panfungol, Ketoderm, Fungarest |
| Tariff item (HS) | 2934 (estimate) |
| Total import duty | about 27.73% |
| Anti-dumping duty (most producers) | None found |
| SCOMET (export control) | Not listed |
| NDPS / precursor | Not listed |
| Drug schedule | H |
| EU CMR classification | Repr. 1B |
Every answer, with its source
Rules in IndiaCHECK
- Not on the Indian banned-pesticide, drug-precursor, narcotic, psychotropic or new-drug lists we check.
- Normal factory, storage and GST rules still apply.
- A Schedule H prescription drug: medicines containing it are sold only on prescription, and making or selling it needs a drug licence. (Drugs and Cosmetics Rules, 1945; salts and preparations are covered too.)
Exporting from IndiaOK
- Not on the SCOMET export-control list or the precursor export list.
- The buyer’s country may still have its own import rules.
Global treaties & export marketsCHECK
- Not listed by the Stockholm Convention (persistent pollutants), the Rotterdam Convention (prior consent before export) or the Montreal Protocol (ozone layer).
- No EU REACH registration found: an EU importer (or your only representative) must register it before importing a tonne or more a year. Medicines and pesticide actives follow their own EU rules.
- Not on the US TSCA Inventory, which does not cover medicines or pesticides; those are regulated by the FDA and EPA (FIFRA).
- EU: harmonised classification as a reproductive toxicant category 1B (CLP Annex VI, index 613-283-00-6). It may not be sold to the general public in the EU as such or in mixtures above the limit (REACH Annex XVII, entries 28-30), and its use at work must be minimised.
Import dutyOK
- About ₹27,730 duty on every ₹1,00,000 of import value (CIF).
- No tariff line names this chemical, so we worked out its likely heading from its structure: 2934, nucleic acids and other heterocyclic compounds (ring containing N and O).
- All lines under heading 2934 pay basic customs duty 7.5%; with social welfare surcharge and IGST 18% that makes about 27.73%.
- Confirm the exact 8-digit code with your customs broker before you import.
SafetySTOP
- Poisonous, even in small amounts
- Can cause long-term health damage
- Harmful to fish and water life
- Toxic if swallowed
- May damage fertility or the unborn child
- May damage fertility
- May cause damage to organs through prolonged or repeated exposure
- Very toxic to aquatic life
- Always read the supplier’s safety data sheet (SDS) before handling.
Storage, transport & PESOOK
- Ships as UN 2811: dangerous-goods rules apply by road, sea (IMDG) and air (IATA), with labels, packaging and a transport document.
Price and suppliersNO DATA
- Post a requirement and we will find suppliers for you.
US patentsOK
- Generic versions can be sold in the US.
- Indian patents are not checked.
Questions about Ketoconazole
What is the import duty on Ketoconazole in India?
The total import duty on Ketoconazole is about 27.73% of the import value under tariff item 2934 (estimate), including basic customs duty, the social welfare surcharge and IGST. Check the latest notifications before you import.
Is there anti-dumping duty on Ketoconazole?
No anti-dumping duty on Ketoconazole was found in the Customs (ADD) notifications in force.
What is the HS code (tariff item) of Ketoconazole in India?
Ketoconazole falls under tariff item 2934 (estimate) of the Customs Tariff of India.
Is Ketoconazole restricted or licensed in India?
Prescription drug: drug licence needed. Not on the Indian banned-pesticide, drug-precursor, narcotic, psychotropic or new-drug lists we check. Normal factory, storage and GST rules still apply.
Does exporting Ketoconazole from India need a licence?
No export licence needed. Not on the SCOMET export-control list or the precursor export list.
Is Ketoconazole hazardous?
Very hazardous: strict controls needed. Poisonous, even in small amounts. Can cause long-term health damage. Harmful to fish and water life.
Is Ketoconazole regulated under global treaties or in the EU and US?
EU: classified carcinogen, mutagen or reproductive toxicant. Not listed by the Stockholm Convention (persistent pollutants), the Rotterdam Convention (prior consent before export) or the Montreal Protocol (ozone layer). No EU REACH registration found: an EU importer (or your only representative) must register it before importing a tonne or more a year. Medicines and pesticide actives follow their own EU rules.
Related chemicals
Guidance from official lists, not legal advice. Rules change; confirm with DGFT, customs or the regulator before you trade.