Obeticholic Acid (CAS 459789-99-2): import duty, licences and trade rules in India

Obeticholic acid is a dihydroxy-5beta-cholanic acid that is chenodeoxycholic acid carrying an additional ethyl substituent at the 6alpha-position. For trade in India: Stop and check: protected in the US until 2033-06-17. Import duty is about 27.73% (tariff item 2918 (estimate)).

Stop and check: protected in the US until 2033-06-17.

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

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Key facts

CAS number459789-99-2
FormulaC26H44O4
Also called6-Ethylchenodeoxycholic acid, Ocaliva, 6-Ethyl-CDCA, acido obeticolico
Tariff item (HS)2918 (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 2020: Obeticholic acid bulk drug and Obeticholic acid 5mg/10mg 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).

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: 2918, carboxylic acids with additional oxygen function (carboxylic acid group).
  • All lines under heading 2918 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
  • Can cause long-term health damage
  • Causes skin irritation
  • Causes serious eye irritation
  • May cause respiratory irritation
  • Suspected of damaging fertility or the unborn child
  • May cause damage to organs through prolonged or repeated exposure
  • Always read the supplier’s safety data sheet (SDS) before handling.

Price and suppliersNO DATA

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

US patentsSTOP

Protected in the US until 2033-06-17
  • The molecule itself is under US patent or exclusivity.
  • Indian patents are not checked.
Source: FDA Orange Book

Questions about Obeticholic Acid

What is the import duty on Obeticholic Acid in India?

The total import duty on Obeticholic Acid is about 27.73% of the import value under tariff item 2918 (estimate), including basic customs duty, the social welfare surcharge and IGST. Check the latest notifications before you import.

Is there anti-dumping duty on Obeticholic Acid?

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

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

Obeticholic Acid falls under tariff item 2918 (estimate) of the Customs Tariff of India.

Is Obeticholic Acid restricted or licensed in India?

Allowed, under the normal registration. A medicine containing it was approved by CDSCO in 2020: Obeticholic acid bulk drug and Obeticholic acid 5mg/10mg tablets. Making or selling medicines needs a drug licence.

Does exporting Obeticholic Acid from India need a licence?

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

Is Obeticholic Acid hazardous?

Hazardous: take normal precautions. Irritates skin, eyes or breathing. Can cause long-term health damage. Causes skin irritation.

Is Obeticholic Acid 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.