Is Resmetirom Available in India? Approval Status, Brands and What Comes Next

No. As of October 2026, resmetirom has no marketing approval in India and no Indian brand is on sale. CDSCO’s expert committee has recommended bioequivalence studies or Phase III trials. Patients currently import Rezdiffra or Bangladeshi generics on a personal-use permit. Torrent has said it will launch only after the patent expires.

Resmetirom in India: Where Things Stand

Resmetirom is not approved for sale in India. No company has CDSCO permission to manufacture and market it. In the records of the Subject Expert Committee (SEC) for gastroenterology and hepatology available up to September 2026, every resmetirom decision concerns a bioequivalence study or a Phase III trial.

In May 2026, Torrent Pharmaceuticals told investors there was “no innovator present in India”.

The drug is approved elsewhere.

In the US and the EU, the approved use is for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) and moderate to advanced liver fibrosis, stages F2 to F3, alongside diet and exercise. How the drug works in the liver is explained in resmetirom mechanism of action.

Resmetirom Brands: What Exists and Where

• Rezdiffra (Madrigal Pharmaceuticals) is the originator brand and the only one approved in the US and the EU. It comes as 60 mg, 80 mg and 100 mg tablets.
• No Indian brand has been approved. A product name that appears on a trade portal is not evidence of approval, because no company holds CDSCO marketing permission.
• Bangladesh has at least 17 generic brands, including Resiliva (Everest Pharmaceuticals), Frehepta (Incepta) and TRB (Square). These are not approved in India.

How Patients in India Get Resmetirom Now

Until a company is approved, the legal route is personal import under Rule 36 of the Drugs and Cosmetics Rules, 1945. The patient submits Form 12A with a prescription from a registered medical practitioner, and CDSCO issues a permit in Form 12B. A traveller carrying the medicine in baggage is limited to 100 average doses of a single drug unless the licensing authority allows more.

Imported packs are expensive, and the price depends on the source; indicative figures are in resmetirom price in India.

Resmetirom is a prescription medicine. The US label warns about liver injury and gallbladder problems, limits the dose of some statins taken with it, and advises avoiding it in decompensated cirrhosis.

What Comes Next

Three things have to line up before an Indian launch.

1. Phase III results. Companies with trial permission have to finish their trials and present the results to the SEC. In September 2026 the committee asked one company to make worsening of fibrosis, assessed by liver biopsy, the primary endpoint over 52 weeks.
2. Patents. Torrent has said it will launch only after the patent expires, which its managing director expected within a year of May 2026. In the US, the compound patent is listed to expire in September 2027, with a patent term extension application pending, and patents on the crystal form run to 2033. The Indian position depends on the patents granted here.
3. Approval. CDSCO then has to grant permission to manufacture and market.

The drug’s global story is not finished either. Its US approval is accelerated, and continued approval may depend on confirmatory trials showing clinical benefit. A separate Phase III trial is testing it in compensated MASH cirrhosis.

What This Means for Indian Formulators

Every company in the timeline above needs the drug substance, first for bioequivalence and Phase III batches and later for commercial launch. Bio-Synth manufactures Resmetirom API at its Balanagar site in Hyderabad, synthesises all Resmetirom intermediates in-house and supplies a Certificate of Analysis with every batch.

What goes into making the API, from the published synthesis to polymorph control, is covered in resmetirom API manufacturing.

Formulators planning a filing can contact Bio-Synth for the specification sheet, a representative Certificate of Analysis and a quotation.

Frequently Asked Questions

Is resmetirom approved in India?

No. As of October 2026, CDSCO has not granted any company permission to market resmetirom in India. Its expert committee has recommended bioequivalence studies and Phase III trials for several companies.

Which companies are developing resmetirom in India?

CDSCO’s expert committee has reviewed applications from more than ten companies, including Sun Pharma, Torrent Pharmaceuticals, Mankind Pharma, Morepen Laboratories, Dr. Reddy’s Laboratories, Macleods and Abbott Healthcare.

What is the brand name of resmetirom?

Rezdiffra, made by Madrigal Pharmaceuticals, is the originator brand approved in the US and the EU. There is no approved Indian brand yet. Generic brands are sold in Bangladesh, including Resiliva (Everest) and TRB (Square).

Can resmetirom be imported into India for personal use?

Yes, with a permit. Under Rule 36 of the Drugs and Cosmetics Rules, 1945, a patient applies in Form 12A with a doctor’s prescription, and CDSCO issues a personal-use permit in Form 12B.

When will resmetirom be launched in India?

No date has been announced. Companies first have to complete Phase III trials and win CDSCO approval. Torrent Pharmaceuticals has said it will launch only after the patent expires.

Can resmetirom be used in cirrhosis?

It is approved only for noncirrhotic MASH with F2 to F3 fibrosis. The US label advises avoiding it in decompensated cirrhosis and says its safety and effectiveness in MASH cirrhosis have not been established. A trial in compensated cirrhosis is ongoing.