Ingrezza access in India: the CDSCO Rule 36 named-patient pathway

Last reviewed 2026-05-12 by Reserve Meds clinical and regulatory team. This page describes the personal-import pathway for Ingrezza in India for adult patients with tardive dyskinesia following long-term antipsychotic therapy, or with chorea associated with Huntington's disease.

Section 1. Quick orientation

Ingrezza is the brand name for valbenazine, an oral once-daily selective vesicular monoamine transporter 2 (VMAT2) inhibitor manufactured by Neurocrine Biosciences. The US Food and Drug Administration approved Ingrezza on 11 April 2017 for tardive dyskinesia (TD) in adults, the first medicine ever approved in the United States for that condition, and on 18 August 2023 for chorea associated with Huntington's disease (HD) in adults. It is not registered with the Central Drugs Standard Control Organization (CDSCO) for commercial sale in India. For adult patients in India whose treating psychiatrist or neurologist has selected valbenazine, the lawful access route is the personal-importation permit under Rule 36 of the Drugs and Cosmetics Rules 1945, applied for on Form 12A and issued on Form 12B by the office of the Drugs Controller General of India. Reserve Meds coordinates the US-side sourcing, documentation kit, and international logistics under a single named coordinator. The clinical decision remains with your physician. Reserved for you.

Section 2. Why India patients need Ingrezza through a named-patient pathway

Three structural gaps recur in Indian patient cases: drugs registered but not stocked, drugs registered for a different indication, and drugs not registered locally at all. Valbenazine sits firmly in the third category. Neurocrine Biosciences' commercial footprint is predominantly US-centred and the company has not filed valbenazine with the CDSCO. There is no locally registered selective VMAT2 inhibitor in India for either of the two indications valbenazine treats. Tetrabenazine, the older nonselective predecessor, is available in some configurations through specialty importers and carries a heavier side-effect burden; deutetrabenazine (Austedo), the other FDA-approved selective VMAT2 inhibitor, is similarly unregistered with the CDSCO.

Two patient populations reach for Ingrezza through Rule 36. First, adult psychiatric patients with diagnosed tardive dyskinesia who developed the condition following long-term exposure to dopamine-receptor-blocking agents (typical or atypical antipsychotics, certain antiemetics), where the treating psychiatrist has identified TD that is not adequately managed by dose reduction of the causative agent. TD is undertreated globally, and Indian psychiatrists at major academic centres often have nothing to offer beyond adjustments to the underlying antipsychotic. Second, Huntington's disease families seeking chorea control, where local neurology cannot source an FDA-approved selective VMAT2 inhibitor and the treating neurologist has determined that the once-daily dosing and tolerability profile of valbenazine is the right next step. Reserve Meds approaches both populations with the respect their conditions deserve; the underlying psychiatric and neurological vulnerabilities are real, and the documentation work is built around them rather than around marketing language.

Section 3. The CDSCO Rule 36 named-patient pathway for Ingrezza

The legal foundation for personal import of an unregistered medicine 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 for a permit to import a small quantity of a drug for personal use under the second proviso to Rule 36. Form 12B is the permit itself, 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. The application is accompanied by a prescription from a Registered Medical Practitioner (RMP) showing the RMP's registration number and the quantity required for treatment. The quantity of any single drug imported shall not exceed one hundred average doses per application.

CDSCO's published guidance states the Form 12B permit is issued on a priority basis, typically within one to two days for routine applications where documentation is complete. In practice, families and hospitals plan for a two to four week window from physician decision to dispensed medicine. A complete application includes a clinical justification letter, the treating physician's National Medical Commission (NMC) registration number with state council registration where required, a patient identifier and supporting medical records, product details (brand name, generic name, manufacturer, strength, quantity), the dispensing facility's drug licence, and a chain-of-custody plan from the US supply chain through to the dispensing pharmacy in India.

The cell-specific clinical-justification angle for Ingrezza differs by indication. For tardive dyskinesia, the file rests on the documented diagnosis of TD (typically AIMS examination score), the duration and identity of the causative dopamine-receptor-blocking agent, evidence that dose reduction or substitution of the causative agent is not clinically acceptable or has not adequately controlled symptoms, and the prescriber's rationale for valbenazine over deutetrabenazine or tetrabenazine. For Huntington's disease chorea, the file rests on the documented HD diagnosis (genetic confirmation with CAG repeat length where available, family history, motor and cognitive examination findings), the chorea severity (UHDRS motor score where available), and the prescriber's rationale for once-daily valbenazine over the alternatives. For HD specifically, the prescriber's letter should explicitly acknowledge the FDA boxed warning for depression and suicidality and document baseline mood and suicidality assessment, with caregiver involvement noted.

Section 4. Where Ingrezza gets dispensed in India

India's tertiary specialty network includes the institutions that handle named-patient imports for psychiatric and neurological medicines as established workflow. The room-temperature handling profile of valbenazine means no specialised cold-chain pharmacy infrastructure is required. All India Institute of Medical Sciences (AIIMS), New Delhi has both strong psychiatry and neurology departments and a movement-disorders programme, and routinely files compassionate and named-patient imports. The National Institute of Mental Health and Neurosciences (NIMHANS) in Bangalore is the apex Indian institution for psychiatric and neurological care; NIMHANS clinicians routinely manage TD and HD families and can support Rule 36 filings through institutional pharmacy infrastructure. Apollo Hospitals (Chennai flagship, Delhi, Bangalore, Hyderabad, Kolkata), Fortis Memorial Research Institute (Gurgaon) and Fortis network sites, Medanta - The Medicity (Gurgaon), Kokilaben Dhirubhai Ambani Hospital (Mumbai), Christian Medical College (CMC) Vellore, and Manipal Hospitals (Bangalore) all hold institutional drug licences and have neurology or psychiatry consultants experienced with movement-disorder and HD management.

For patients whose treating clinician practices at a smaller hospital or a clinic without internal import infrastructure, the common pattern is to route through a CDSCO-licensed specialty importer in Mumbai, Delhi, or Bangalore that files the Rule 36 application on the prescribing physician's behalf. The importer handles customs at the port of entry, takes receipt of the shipment under chain-of-custody documentation, and delivers the medicine to the prescribing hospital's outpatient pharmacy. For HD families coordinating across multiple cities, the single-coordinator model carried by Reserve Meds, AIIMS, NIMHANS, or a private importer matters; HD is a multi-generational diagnosis and the case file often spans several family members.

Section 5. Real cost picture for Ingrezza in India

Costs sit in Indian rupees with the rupee floating against the US dollar. In May 2026 the USD/INR rate is in the 94 to 95 range. Reserve Meds quotes are itemised, not bundled.

• Drug cost reference. US wholesale acquisition cost at the original 2017 launch was USD 5,275 per 30-count bottle of 40 mg capsules. Public pricing sources in 2026 cite a 28-capsule bottle of 40 mg at roughly USD 7,900 and 80 mg at roughly USD 8,700, working out to an approximate annual list-price range of USD 103,000 to USD 113,000 at maintenance dosing. Ingrezza is a long-term therapy, so annual exposure rather than per-bottle pricing is the right frame for family budgeting. International cash-pay procurement for named-patient orders prices above US WAC in line with NPP norms.
• International logistics. Ambient room-temperature shipping for an oral small molecule, USD 400 to 1,500 (approximately INR 38,000 to 142,000) depending on destination port and urgency window. No cold chain is required for valbenazine.
• Regulatory and concierge. CDSCO Form 12B fees and customs handling are nominal relative to drug cost. Standard customs duty and 12 percent GST apply unless the consignment qualifies under a specific exemption confirmed at documentation stage. Reserve Meds' concierge coordination fee is itemised separately on every firm quote.

India's private insurance market is large and segmented. Star Health and Allied Insurance, HDFC ERGO, ICICI Lombard, and Niva Bupa each handle named-patient imports case by case. None reimburses a Rule 36 personal import as a standard line item. CGHS provides for life-saving medicines not in the standard formulary to be considered by an Expert Committee under Special DG (DGHS) for life-threatening or seriously debilitating conditions; HD chorea and severe TD may qualify for Expert Committee review depending on the documented clinical impact. ESIC's formulary is narrower. Reserve Meds supplies the documentation that lets an insurer or scheme assess; the claim sits with you or your hospital. Cash-pay is the default posture.

Section 6. Typical timeline for Ingrezza in India

The room-temperature handling profile keeps Ingrezza on the lower-friction side of the Reserve Meds logistics matrix. CDSCO Form 12B issuance for routine cases with complete documentation is typically one to two days per CDSCO published guidance. US-side procurement is the slower variable. Ingrezza is supplied in the United States exclusively through Neurocrine's contracted specialty pharmacy network rather than open wholesale distribution, which adds an authentication and chain-of-custody layer compared with open-channel small molecules. A reasonable end-to-end estimate from intake to first dose in hand is 3 to 5 weeks for a first import; refill cycles compress to 2 to 3 weeks because the prescriber documentation reuses the original file and the specialty pharmacy authentication is established. These ranges are typical, not promises.

Section 7. What your physician needs to provide

The clinical justification letter is the cornerstone of the Rule 36 application. The letter content differs by indication.

For tardive dyskinesia: the patient identifier, the TD diagnosis with examination findings (AIMS score where available), the identity and duration of the causative dopamine-receptor-blocking agent, evidence that dose reduction or substitution has been considered and is not clinically acceptable or sufficient, baseline assessment of mood and any psychiatric comorbidities, ECG or QT-prolongation risk assessment for patients on QT-prolonging medications or with known CYP2D6 poor metaboliser status, and the prescriber's rationale for valbenazine.

For Huntington's disease chorea: the HD diagnosis with genetic confirmation and CAG repeat length where available, the family pedigree, the chorea severity, baseline mood assessment with explicit acknowledgement of the FDA boxed warning for depression and suicidality, caregiver involvement in the monitoring plan, baseline parkinsonism and sedation assessment, and the prescriber's rationale for valbenazine over the alternatives.

Dosing in both indications aligns with the FDA-approved label. TD: 40 mg orally once daily for one week, then 80 mg once daily, with 40 mg or 60 mg considered for patients who do not tolerate 80 mg. HD chorea: 40 mg once daily start, titrate weekly in 20 mg increments based on chorea reduction and tolerability up to a maximum recommended dose of 80 mg once daily. Dose reductions to a maximum of 40 mg once daily are required for patients on strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or known CYP2D6 poor metabolisers. Treatment is chronic; the requested pack quantity should reflect the long-term nature of therapy and stay within the Rule 36 100-dose-per-application cap, which allows roughly a three-month supply per filing at maintenance dosing.

Section 8. Common questions about Ingrezza in India

Will Star Health, HDFC ERGO, ICICI Lombard, or Niva Bupa cover this? Each insurer assesses named-patient imports case by case. None reimburses a Rule 36 personal import as a standard line item. We do not promise coverage from any insurer.

Will my CGHS or ESIC entitlement cover this? CGHS provides for life-saving and seriously debilitating-condition medicines not in the standard formulary to be considered by an Expert Committee under Special DG (DGHS) case-by-case. Drugs not approved by the DCGI face a stricter review. ESIC's formulary is narrower. Check eligibility with your CGHS Wellness Centre or ESIC dispensary before assuming coverage.

Will my NMC-registered psychiatrist or neurologist's letter be sufficient? Yes. Any Registered Medical Practitioner with a valid NMC registration number can support a Form 12A application. Psychiatrists and neurologists at AIIMS, NIMHANS, Apollo, Fortis, Medanta, Kokilaben, CMC Vellore, and Manipal routinely sign these letters as part of established institutional workflow.

What is the safety profile? The FDA label for valbenazine in the Huntington's disease chorea indication carries a boxed warning for depression and suicidality, reflecting the underlying psychiatric vulnerability of the HD population. This boxed warning is specific to the HD chorea indication and is not present in the original TD label. The most commonly reported adverse reaction across both indications is somnolence. Other notable warnings include QT prolongation, parkinsonism (including hypokinesia and rigidity), and neuroleptic malignant syndrome. For HD patients, baseline and ongoing assessment of mood, suicidal ideation, and depressive symptoms is required, with caregivers and clinicians both involved.

How is Ingrezza different from Austedo? Deutetrabenazine (Austedo) is the other FDA-approved selective VMAT2 inhibitor, also indicated for TD and HD chorea. Once-daily dosing is the most cited practical advantage of valbenazine; deutetrabenazine is dosed twice daily with food. Tolerability and side-effect profile differ. The decision is clinical and belongs with the treating specialist.

Can the dose be stopped abruptly? Capsules should be taken whole unless the Sprinkle formulation is prescribed. The label does not require gradual taper, but any change to therapy should be made by the prescribing clinician.

Section 9. Where Reserve Meds fits in Ingrezza cases

Reserve Meds is a US-based concierge coordinator. We do not replace your psychiatrist or neurologist, do not replace the CDSCO, and do not replace your dispensing pharmacy or licensed importer. For Ingrezza specifically, the orchestration we provide is a documentation kit your physician uses to assemble the Rule 36 application, US-side procurement through Neurocrine's contracted specialty pharmacy channel, ambient air-freight logistics under pharmaceutical-grade packaging, customs documentation aligned to the Form 12B permit, and a single named coordinator who stays with your case from intake through delivery. For HD chorea cases, the coordinator additionally surfaces the FDA boxed warning for depression and suicidality in patient-facing materials and confirms acknowledgement by the treating neurologist before procurement begins. No prior Reserve Meds case experience exists for Ingrezza at the date of this page. Standard NPP coordination applies.

Section 10. Next step

If your psychiatrist or neurologist has selected Ingrezza and you or your family member is based in India, the next step is the waitlist. We confirm eligibility within 24 to 48 hours and send a documentation kit to your physician. Reserved for you.

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This guide is informational, not medical or legal advice. The Rule 36 framework requires a Registered Medical Practitioner's clinical judgment; Reserve Meds is the coordinator, not the prescriber.