Darolutamide (CAS 1297538-32-9): import duty, licences and trade rules in India

For trade in India: Stop and check: protected in the US until 2038-02-27. Import duty is about 27.73% (tariff item 2933 (estimate)).

Stop and check: protected in the US until 2038-02-27.

Checked 2026-10-31 against official Indian and international lists. Sources are given under each answer.

Run the live check Open in Compound Workspace Search RasayanXchange

Key facts

CAS number1297538-32-9
FormulaC19H19ClN6O2
Also calledNubeqa, darolutamida, BAY 1841788, 1H-Pyrazole-3-carboxamide, N-[(1S)-2-[3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl]-1-methylethyl]-5-(1-hydroxyethyl)-
Tariff item (HS)2933 (estimate)
Total import dutyabout 27.73%
Anti-dumping duty (most producers)None found
SCOMET (export control)Not listed
NDPS / precursorNot listed

Every answer, with its source

Rules in IndiaOK

Allowed, under the normal registration
  • A medicine containing it was approved by CDSCO in 2021: Darolutamide 300mg film coated tablets.
  • Making or selling medicines needs a drug licence.
Source: CIB&RC pesticide lists · CDSCO new drug approvals · NDPS RCS Order 2013

Exporting from IndiaOK

No export licence needed
  • Not on the SCOMET export-control list or the precursor export list.
  • The buyer’s country may still have its own import rules.
Source: DGFT SCOMET list · NDPS RCS Order 2013

Global treaties & export marketsOK

No treaty or export-market restriction found
  • 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).
Source: Stockholm Convention, all listed POPs · Rotterdam Convention Annex III · Montreal Protocol annexes (ozone layer, Kigali HFCs) · US EPA TSCA Inventory · ECHA REACH lists, as published in PubChem

Import dutyOK

About 27.73% of the import value (estimate)
  • 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: 2933, heterocyclic compounds with nitrogen hetero-atom(s) only (ring containing nitrogen).
  • 82 of 88 lines under heading 2933 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.
Source: Customs Tariff of India, CBIC · Notification 45/2025-Customs · Notification 9/2025-Integrated Tax (Rate)

SafetyCHECK

Hazardous: take normal precautions
  • Irritates skin, eyes or breathing
  • Harmful to fish and water life
  • Harmful if swallowed
  • Very toxic to aquatic life
  • Very toxic to aquatic life with long lasting effects
  • Always read the supplier’s safety data sheet (SDS) before handling.
Source: PubChem GHS classification

Price and suppliersNO DATA

Not on RasayanXchange yet
  • Post a requirement and we will find suppliers for you.
Source: RasayanXchange market data

US patentsSTOP

Protected in the US until 2038-02-27
  • The molecule itself is under US patent or exclusivity.
  • Indian patents are not checked.
Source: FDA Orange Book

Questions about Darolutamide

What is the import duty on Darolutamide in India?

The total import duty on Darolutamide is about 27.73% of the import value under tariff item 2933 (estimate), including basic customs duty, the social welfare surcharge and IGST. Check the latest notifications before you import.

Is there anti-dumping duty on Darolutamide?

No anti-dumping duty on Darolutamide was found in the Customs (ADD) notifications in force.

What is the HS code (tariff item) of Darolutamide in India?

Darolutamide falls under tariff item 2933 (estimate) of the Customs Tariff of India.

Is Darolutamide restricted or licensed in India?

Allowed, under the normal registration. A medicine containing it was approved by CDSCO in 2021: Darolutamide 300mg film coated tablets. Making or selling medicines needs a drug licence.

Does exporting Darolutamide from India need a licence?

No export licence needed. Not on the SCOMET export-control list or the precursor export list.

Is Darolutamide hazardous?

Hazardous: take normal precautions. Irritates skin, eyes or breathing. Harmful to fish and water life. Harmful if swallowed.

Is Darolutamide regulated under global treaties or in the EU and US?

No treaty or export-market restriction found. 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.

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Guidance from official lists, not legal advice. Rules change; confirm with DGFT, customs or the regulator before you trade.