Rezdiffra access in India through the CDSCO Rule 36 Form 12A pathway
How Indian patients with noncirrhotic MASH (NASH) and moderate-to-advanced liver fibrosis source Rezdiffra (resmetirom) under the CDSCO Rule 36 framework, with the non-invasive diagnostic documentation Indian hepatologists need to file the Form 12A application.
Last reviewed 2026-05-12 by Reserve Meds clinical and regulatory team.
Ask about Rezdiffra in India
Tell us the medicine and your country. We reply within one business day. On WhatsApp we usually reply the same day.
Quick orientation
Rezdiffra is the brand name for resmetirom, an oral once-daily, liver-directed thyroid hormone receptor-beta (THR-beta) selective agonist. The US FDA granted accelerated approval on 14 March 2024 for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH, now also referred to as MASH) with moderate to advanced liver fibrosis, stages F2 to F3, in combination with diet and exercise. It is the first FDA-approved therapy for this indication. Rezdiffra may not be registered with CDSCO (we confirm its current CDSCO status for your case at intake). Patient-level access flows through Rule 36 of the Drugs and Cosmetics Rules 1945, prescribed by an NMC-registered hepatologist or gastroenterologist and dispensed through a hospital pharmacy or a CDSCO-licensed specialty importer. Reserve Meds coordinates the US-side sourcing and the documentation kit your Indian hepatologist needs to file the Form 12A application.
Case active and ready to skip the regulatory walkthrough? Ask about a medicine or WhatsApp us.
Why Indian patients need Rezdiffra through the named-patient pathway
India sits at the centre of the global metabolic-syndrome burden. The structural gap in India fits the third pattern the country module describes: Rezdiffra is FDA-approved (and EU-approved under European Commission conditional marketing authorisation granted 19 August 2025) but Madrigal Pharmaceuticals has not pursued a CDSCO marketing authorisation, and the drug is not on any Indian hospital formulary as of May 2026.
The pre-Rezdiffra treatment gap in India was real. There was no FDA-approved or CDSCO-registered MASH-specific therapy. Hepatologists managed metabolic risk factors, used GLP-1 receptor agonists off-label for comorbid diabetes and obesity, and watched for progression to cirrhosis. The arrival of the first liver-directed disease-modifying agent for noncirrhotic MASH with F2-F3 fibrosis created a step change in demand from regional hepatology referral centres. Rule 36 is the appropriate route: an FDA-approved medicine, no locally registered or stocked alternative for the MASH F2-F3 histologic indication, and a chronic progressive condition where the treating hepatologist documents the specific reason this product is required for the named patient.
The CDSCO Rule 36 personal import pathway for Rezdiffra
The legal foundation for personal import of unregistered medicines into India is Rule 36 of the Drugs and Cosmetics Rules 1945. Rule 36 permits import of small quantities of a drug, whose import would otherwise be prohibited under Section 10 of the Drugs and Cosmetics Act 1940, for the exclusive personal use of a named patient. Form 12A is the application; Form 12B is the permit, issued by the office of the Drugs Controller General of India (DCGI) at FDA Bhawan, Kotla Road, New Delhi, or by designated CDSCO Port Offices. We give you a written timeline estimate for your case before you commit.
For Rezdiffra specifically, the clinical-justification angle that anchors the Form 12A application is the non-invasive testing (NIT) diagnostic gate. The FDA-approved label does not require liver biopsy to start treatment, which broadens the documentation an Indian hepatologist can use to qualify a named patient. The application is strongest when the hepatologist's letter sets out (1) the diagnosis of noncirrhotic MASH with moderate to advanced liver fibrosis stages F2 to F3, (2) the non-invasive testing result that supports the fibrosis stage (transient elastography by FibroScan with the kPa value reported, or magnetic resonance elastography with the kPa value reported, or a validated blood-based panel such as Enhanced Liver Fibrosis (ELF), often combined with FAST or MAST composite scores), (3) baseline liver biochemistry (ALT, AST, alkaline phosphatase, total bilirubin), (4) absence of decompensated cirrhosis (Child-Pugh A; Child-Pugh B or C use is not recommended per the label), (5) body weight to determine the 80 mg or 100 mg once-daily dose, and (6) screening for concomitant statin and CYP2C8-inhibitor medications that may require dose modification.
A complete Form 12A application includes the clinical justification letter from the treating Registered Medical Practitioner, the prescription showing the RMP's NMC registration number and the quantity required for treatment, a patient identifier with supporting medical records and the NIT report, product details (Rezdiffra as resmetirom 80 mg or 100 mg film-coated tablets, manufacturer Madrigal Pharmaceuticals, 30-tablet bottle aligned to a 30-day course, requested quantity not exceeding 100 average doses per application per the second proviso to Rule 36), the dispensing facility's drug licence, and a chain-of-custody plan from the US specialty pharmacy through the importer to the receiving Indian pharmacy. For institutional Compassionate Use, the parallel route is a Compassionate Use application to the DCGI by a government hospital, an RMP, or the patient.
Where Rezdiffra gets dispensed in India
Named-patient medicines are usually given or dispensed at tertiary hospitals with the right specialist team and an in-house import pharmacy. Your treating hospital confirms its own process.
For patients outside the major metros, co-management with a hepatologist at one of the centres above is the practical route, with refills routed through that hospital's import pharmacy or a CDSCO-licensed specialty importer in Mumbai, Delhi, or Bangalore.
Real cost picture for Rezdiffra in India
Medicine price: quote on request. You get a written quote for your case before you commit.
Standard tamper-evident specialty pharmacy packaging is retained through the international leg. GST on most life-saving medicines is 5 percent; the specific HSN code and any Union Budget 2026-27 customs duty exemption status is confirmed at the documentation stage. Rezdiffra Cares (Madrigal's US-only patient support programme, including copay assistance for commercially insured US patients) does not extend to international cases. None reimburse a Rule 36 personal import as a standard line item, and CGHS or ESIC routes face stricter Expert Committee review for DCGI-unapproved drugs. Cash-pay with optionality to pursue reimbursement after the fact is the default operating posture.
Typical timeline for Rezdiffra in India
Rezdiffra is room-temperature stable, which keeps the modality-adjusted timeline at the simpler end of the country module range. We give you a written timeline estimate for your case before you commit. NIT confirmation (FibroScan or MRE result with reported kPa value) sometimes adds upstream time if a baseline study has not already been done. Repeat monthly refill cycles for an established patient typically compress to 2 to 3 weeks because the Form 12A dossier and the procurement path are already in place. A quarterly or semi-annual cadence is feasible once the hepatologist confirms supply alignment with monitoring visits.
What your physician needs to provide
The treating hepatologist's clinical justification letter is the cornerstone of the Form 12A package. For Rezdiffra specifically, the letter typically addresses:
- Mechanism and FDA indication. Resmetirom is an oral, liver-directed THR-beta selective agonist that activates THR-beta in hepatocytes to reduce hepatic triglyceride accumulation, hepatocellular injury, and downstream fibrogenesis without meaningful THR-alpha activity. FDA accelerated approval 14 March 2024 for adults with noncirrhotic MASH and moderate to advanced liver fibrosis (F2-F3) in combination with diet and exercise.
- Diagnostic confirmation. Non-invasive testing is the gate. FibroScan kPa value (transient elastography), MRE kPa value (magnetic resonance elastography), or a validated blood-based panel such as ELF, often combined with FAST or MAST composite scores. The pivotal MAESTRO-NASH trial enrolled by biopsy, but the FDA label does not require biopsy for diagnosis or treatment initiation.
- Dosing plan. Once daily, taken orally with or without food, swallowed whole. Body weight less than 100 kg: 80 mg once daily. Body weight 100 kg or greater: 100 mg once daily. The 60 mg strength supports dose-modification scenarios per the prescribing information.
- Concomitant medication review. Statins and CYP2C8 inhibitor co-administration require dose-adjustment review per the label.
- Exclusion of decompensated cirrhosis. Use is not recommended in patients with decompensated cirrhosis (Child-Pugh B or C). The clinical letter confirms Child-Pugh A status.
- Monitoring plan. Baseline and periodic monitoring of ALT, AST, alkaline phosphatase, and total bilirubin with defined thresholds for dose interruption. Pregnancy is avoided during treatment per the label.
- Physician registration. Active NMC registration in hepatology, gastroenterology, or internal medicine, with state-council registration where required.
- Pharmacovigilance acknowledgement. The Pharmacovigilance Programme of India (PvPI) coordinated by the Indian Pharmacopoeia Commission is referenced; adverse event reporting through PvPI stays with the prescribing physician.
Common questions about Rezdiffra in India
Will a private insurer cover this?
Each plan handles named-patient imports case by case. None reimburse a Rule 36 personal import as a standard line item, and Rezdiffra is not on any Indian formulary as of this page date. We supply the documentation that lets your insurer evaluate; the claim itself is filed by you or your hospital. Cash-pay is the default operating posture.
Does liver biopsy need to be done first?
No. The FDA-approved label does not require liver biopsy for diagnosis or treatment initiation. Diagnosis of MASH with F2 to F3 fibrosis can be supported by non-invasive testing including FibroScan, MRE, or validated blood-based panels such as ELF, often combined with FAST or MAST composite scores. This NIT diagnostic gate is the meaningful practical change versus the biopsy-based enrolment criteria of the MAESTRO-NASH pivotal trial. Your hepatologist documents the NIT result in the Form 12A package.
Are GLP-1 agonists like semaglutide a substitute?
GLP-1 receptor agonists are studied for MASH and are widely used by Indian clinicians for the comorbid metabolic disease (type 2 diabetes, central obesity) that drives MASH. They are not FDA-approved for the MASH histologic indication, and Reserve Meds does not endorse off-label substitution. The choice between adding a MASH-directed agent and managing metabolic risk factors alone is a clinical decision your hepatologist makes.
How long does treatment continue?
Therapy is chronic and ongoing per the FDA label. There is no defined stop date. Continuation is based on the treating hepatologist's longitudinal assessment, including tolerability, monitoring labs, and longitudinal NIT to track fibrosis. Treatment may be paused or discontinued if predefined ALT, AST, or bilirubin thresholds are crossed, or if the patient progresses to decompensated cirrhosis.
What is the safety profile?
The most commonly reported adverse events in the MAESTRO-NASH trial were diarrhoea and nausea, both more frequent on resmetirom than placebo and generally occurring early in therapy. The FDA label includes warnings around drug-induced liver injury, hepatic decompensation in unrecognised cirrhosis, and gallbladder-related adverse reactions. The prescribing hepatologist owns the safety assessment and the periodic-monitoring plan.
Does CGHS or ESIC cover Rezdiffra?
CGHS provides for life-saving medicines not in the standard formulary to be considered by an Expert Committee under the Special DG (DGHS), case by case. Drugs not approved by the DCGI for use in India (including Rezdiffra as of this page date) face stricter Expert Committee review. ESIC's formulary is narrower. Neither scheme is structured for routine personal-import reimbursement; check eligibility with your CGHS Wellness Centre or ESIC dispensary before assuming coverage.
Where Reserve Meds fits in Rezdiffra cases
Reserve Meds is a US-based digital health company. We do not replace your hepatologist, CDSCO, or your dispensing pharmacy. For Rezdiffra specifically, we orchestrate supply through a US-licensed pharmaceutical wholesale partner with full DSCSA chain-of-custody documentation, prepare the documentation kit your Indian hepatologist needs to file the Form 12A application (with the NIT diagnostic-gate template, weight-banded dosing reference, and PvPI acknowledgement pre-built for MASH cases), align the ambient air-freight shipment plan with the Indian importer or hospital pharmacy, and assign a single point of contact who carries the case from first contact through the monthly refill cadence. Standard Rule 36 coordination applies.
Next step
If you have a diagnosis of noncirrhotic MASH with F2 to F3 fibrosis on non-invasive testing and your Indian hepatologist has identified Rezdiffra as the right next step, submit your intake to our case team. We will confirm eligibility within one business day and send the documentation kit to your physician.
Reserved for you.
This guide is informational, not medical or legal advice. The CDSCO Rule 36 pathway requires an NMC-registered physician's clinical judgment; Reserve Meds is the coordinator, not the prescriber.