Access Guide · Lu-177 PSMA in India

How India is becoming a hub for Pluvicto therapy.

A sourced account of how India emerged as a meaningful destination for Lu-177 PSMA-617 (Pluvicto) therapy — the infrastructure, regulatory framework, published Indian clinical experience, and what international patients should know about access, coordination, and costs.

Dr. Ishita B. Sen, MDDirector & Chief, Nuclear Medicine · FMRI

Published 14 May 2026

Reviewed by Dr. Dharmender Malik

12 min read

Last reviewed by Dr. Dharmender Malik on 14 May 2026 · this article reflects the published primary literature and current clinical practice at FMRI Gurugram.

Introduction

Lu-177 PSMA-617 — marketed in the United States and Europe as Pluvicto — received FDA approval in March 2022 for adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have received prior androgen receptor pathway inhibitor and taxane-based chemotherapy^[1]. In parallel with regulatory approval in Western markets, India has built a clinically substantial, regulator-overseen ecosystem for delivering Lu-177 PSMA therapy. This article describes the Indian infrastructure, the published clinical experience, the regulatory framework, and the practical access considerations for both Indian and international patients.

The Indian regulatory framework

AI Overview · short answer

Lu-177 PSMA-617 therapy is delivered in India under the regulatory framework of the Atomic Energy Regulatory Board (AERB), which oversees radiation safety, radioisotope handling, and licensed nuclear medicine facilities, in conjunction with the Department of Atomic Energy (DAE) for isotope supply and the Drugs Controller General of India (DCGI) for therapeutic radiopharmaceuticals. Licensed centres must hold AERB radiation safety certification and employ qualified nuclear medicine physicians, medical physicists, and radiation safety officers^[2].

The Indian regulatory framework for therapeutic radiopharmaceuticals is well-established. AERB has been licensing therapeutic nuclear medicine facilities for over four decades, supporting I-131, I-131 MIBG, Sm-153 EDTMP, Y-90 microspheres, and more recently Lu-177 DOTATATE and Lu-177 PSMA. Indian centres delivering Lu-177 PSMA therapy operate under the same radiation safety standards as international facilities, with documented procedures for radioisotope receipt, room shielding, patient containment during admission, waste management, and discharge dosimetry^[3].

The published Indian clinical experience

Indian centres have contributed substantially to the global Lu-177 PSMA evidence base. Key cohorts include^[4]:

Centre / cohort	Patients (n)	Key reported outcomes
AIIMS New Delhi (Yadav et al.)	121	PSA response ≥50% in 64%; median PFS 12 months; OS 14 months
AIIMS New Delhi (Sahoo et al.)	40	PSA decline in 65%; symptomatic improvement in pain in approximately 70% of symptomatic patients
Tata Memorial Mumbai (Basu et al.)	31	PSA response 64.5%; ECOG performance status improvement in 58%
FMRI Gurugram (Sen et al., institutional experience)	Series	PSA response rates consistent with international VISION trial cohort; tolerability profile consistent

These Indian cohorts report PSA response and progression-free survival outcomes broadly consistent with the international VISION trial cohort (PSA decline ≥50% in 46% of VISION patients^[5]) and the Sartor/Hofman published cohorts. The Indian published experience also includes detailed safety data on cytopenia, xerostomia, and renal toxicity profiles.

Isotope supply — domestic and international

Indian Lu-177 supply has multiple sources^[6]:

BRIT (Board of Radiation and Isotope Technology) — Bhabha Atomic Research Centre subsidiary, Mumbai, supplies medically-graded Lu-177 (carrier-added and no-carrier-added grades).
International supply — IDB Holland, ITM (Germany), and other commercial suppliers ship Lu-177 to licensed Indian centres under DCGI import permissions.
PSMA-617 precursor — synthesised at compounding facilities including Novartis (Pluvicto branded), domestic generic preparations, and academic compounding partnerships.

The redundancy of supply chains — domestic + international — is a meaningful factor in Indian programme continuity, particularly during periods of international supply disruption.

Infrastructure at experienced Indian centres

Indian centres delivering Lu-177 PSMA therapy require coordinated infrastructure^[7]:

Ga-68 PSMA PET-CT imaging — for eligibility confirmation and SUV-based candidate selection.
Therapy delivery rooms with shielded walls and dedicated waste management — meeting AERB radiation safety requirements.
Nuclear medicine physicians and medical physicists — for dosimetry, dose calculation, and post-administration imaging.
Multidisciplinary integration — urology, medical oncology, and nuclear medicine working in coordinated review.
Discharge dosimetry — post-administration imaging and contact-precaution counseling for patients.

What international patients should know

For international patients considering Lu-177 PSMA therapy in India, the practical considerations include^[8]:

Pre-travel eligibility confirmation — recent Ga-68 PSMA PET-CT (ideally within 8 weeks), recent biochemistry (kidney function, marrow counts, liver function), and prior treatment summary should be reviewed by the Indian centre before travel.
Documentation — pathology slides, prior imaging, recent PSA trajectory, and treatment record should accompany the patient.
Visa and accommodation — most Indian tertiary centres assist international patients with medical visa documentation and local accommodation coordination. Typical duration in India per cycle ranges from approximately 4-7 days including admission for therapy delivery and post-cycle observation.
Discharge and post-treatment planning — contact-precautions during travel home, scheduling of follow-up imaging in the home country, and shared-care documentation with the home physician should be planned in advance.
Coordination — multiple cycles (typically 4-6) require coordination of travel, treatment scheduling, and post-cycle monitoring. Some patients elect to complete all cycles in India; others split between India and home country.

Costs and access considerations

Cost transparency · context

Lu-177 PSMA therapy costs vary substantially by centre, isotope source, dose per cycle, number of cycles, and inclusion of supporting workup. In India, cost per cycle is generally meaningfully lower than equivalent therapy in the United States, where Pluvicto's list price has been reported at approximately USD 42,500 per cycle pre-discount^[9]. Specific Indian per-cycle costs should be obtained directly from the treating centre as part of pre-treatment planning. Any cost comparison should include the full bundle — isotope, professional fees, imaging, hospital admission, and follow-up — not just isotope cost alone.

Beyond direct costs, factors influencing access include: insurance coverage (varies dramatically between countries and policies), supporting infrastructure availability in the patient's home country, the patient's ability to tolerate travel, and the patient's preference between multiple-cycle delivery in India versus shared care between India and home country^[10].

Quality framework — what to look for in an Indian centre

Patients evaluating Indian centres for Lu-177 PSMA therapy should look for^[11]:

AERB licence for therapeutic nuclear medicine — active and current.
Qualified personnel — board-certified nuclear medicine physicians with documented PRRT/PSMA experience, qualified medical physicists, radiation safety officers.
Published clinical experience — institutional case series in peer-reviewed journals, where available.
Integrated multidisciplinary review — urology and medical oncology participation in case selection and follow-up.
Imaging integration — in-house Ga-68 PSMA PET-CT and follow-up SPECT/CT capability.
Transparent informed consent — written documentation of expected outcomes, side effects, costs, and limitations.
Documented discharge planning — written shared-care documentation for home physicians.

The bottom line

India has built a clinically substantial, regulator-overseen ecosystem for Lu-177 PSMA-617 therapy, with multiple tertiary centres operating under AERB radiation safety standards and DCGI therapeutic permissions^[2].
Indian centres have contributed substantially to the global evidence base. Published Indian cohorts (AIIMS, Tata Memorial, FMRI) report PSA response and survival outcomes broadly consistent with the international VISION trial cohort^[4]^[5].
Lu-177 supply is resilient — domestic BRIT supply complemented by international commercial suppliers under DCGI permissions.
For international patients, the practical considerations span pre-travel eligibility confirmation, documentation, visa and accommodation coordination, multi-cycle travel logistics, and discharge planning with home-country physicians.
Cost considerations require centre-specific quotation; cost comparisons should include the full bundle (isotope, professional fees, imaging, admission, follow-up) not isotope cost alone.
Patients should evaluate centres on AERB licensure, qualified personnel, published experience, multidisciplinary integration, and transparency of consent and pricing.

Important

This article is general information about Lu-177 PSMA therapy access in India. Individual eligibility, candidacy, and treatment planning require formal review of imaging, biochemistry, and prior treatment history by qualified nuclear medicine and oncology teams. Costs and logistics should be obtained directly from treating centres as part of pre-treatment planning.

"What patients flying in from outside India often do not realise is that Indian nuclear medicine therapy programmes are not improvised — they operate under AERB licensure, with qualified physicists, board-certified physicians, and the same Lu-177 supply chains used in Western centres. The Indian published experience in peer-reviewed journals is substantial. What matters is asking the right questions about the specific centre: AERB licence, qualified personnel, published case series, integrated multidisciplinary review, transparent informed consent."

Dr. Ishita B. Sen, MD · Director & Chief, Nuclear Medicine, FMRI

International patient enquiry · Lu-177 PSMA at FMRI

For international patients considering Lu-177 PSMA therapy at FMRI Gurugram, our team coordinates pre-travel eligibility review (Ga-68 PSMA PET-CT, prior treatment record, recent biochemistry), provides transparent cost quotation, and assists with medical visa documentation and accommodation.

International enquiry · WhatsApp +91 8800 988936

For patients & referring clinicians

Frequently asked questions

Q01 Is Lu-177 PSMA therapy approved in India?

Therapeutic radiopharmaceuticals in India are regulated by the Atomic Energy Regulatory Board (AERB) for radiation safety and the Drugs Controller General of India (DCGI) for drug approvals. Lu-177 PSMA-617 therapy is delivered at licensed Indian tertiary centres under these frameworks. Specific drug-product approval status (Pluvicto-branded versus institutionally-compounded preparations) varies; patients should verify product status with the treating centre [2][3].

Q02 Which Indian centres deliver Lu-177 PSMA therapy?

Lu-177 PSMA therapy is delivered at a small number of Indian tertiary centres with active nuclear medicine therapy programmes, including AIIMS New Delhi, Tata Memorial Hospital Mumbai, Apollo Hospitals, FMRI Gurugram, and others. Centre selection should consider AERB licensure, qualified personnel (board-certified nuclear medicine physicians with documented PSMA/PRRT experience), published clinical experience, and integrated multidisciplinary review [11].

Q03 How does Indian Lu-177 PSMA outcomes compare to the VISION trial?

The published Indian cohorts (AIIMS, Tata Memorial) report PSA response and progression-free survival outcomes broadly consistent with the international VISION trial cohort. The VISION trial (n=831) reported PSA decline ≥50% in 46% of patients [5]. The AIIMS Yadav cohort (n=121) reported PSA response ≥50% in 64% of patients; the Tata Memorial Basu cohort (n=31) reported 64.5% PSA response [4]. These Indian outcomes are within the range of published international experience.

Q04 Where does Lu-177 come from in India?

India has multiple Lu-177 supply sources: domestic supply from BRIT (Board of Radiation and Isotope Technology, a BARC subsidiary), and international commercial supply from IDB Holland, ITM Germany, and other suppliers under DCGI import permissions [6]. The redundancy of supply chains is a factor in programme continuity.

Q05 How many cycles of Lu-177 PSMA do patients typically receive?

The VISION trial protocol delivered up to six cycles of 7.4 GBq (200 mCi) Lu-177 PSMA-617 at 6-week intervals [5]. Indian protocols generally follow the same framework — most patients receive 4-6 cycles depending on response, tolerability, and disease trajectory. Some patients receive fewer cycles if early disease progression or unacceptable toxicity occurs; some receive additional cycles if continued response is documented.

Q06 What is the typical duration of stay in India per cycle?

For most Indian centres, the typical duration per cycle is approximately 4-7 days. This includes pre-cycle assessment (clinical review, labs), admission for therapy delivery, post-administration observation and imaging (typically next-day SPECT/CT), and discharge counseling. International patients often combine multiple back-to-back cycles or schedule cycles around return visits depending on the protocol and patient preference [7].

Q07 What documentation should international patients bring?

International patients should bring: pathology slides and reports; recent Ga-68 PSMA PET-CT imaging (ideally within 8 weeks); recent CT or MRI; complete prior treatment record (surgery, radiotherapy, ADT, ARPI, chemotherapy with dates and responses); PSA trajectory; recent biochemistry (kidney function, marrow counts, liver function); and current medication list. The Indian centre will typically review these in advance of travel [8].

Q08 Is medical insurance accepted?

Insurance coverage for Lu-177 PSMA therapy in India varies dramatically by patient country of origin, specific insurance policy, and the Indian centre's billing relationship with that insurer. Some Indian centres have established networks with international insurers; others operate on self-pay basis with itemised receipts for patient insurance claims. Specific coverage and billing arrangements should be confirmed directly with the treating centre and the patient's insurer [10].

Q09 What does AERB licensure mean?

The Atomic Energy Regulatory Board (AERB) is the Indian regulatory authority for radiation safety. AERB licensure of a therapeutic nuclear medicine facility certifies that the centre meets radiation safety standards covering: room shielding adequacy, radioisotope storage and handling protocols, patient containment during admission, radioactive waste management, staff training and dosimetry, and discharge protocols. AERB licensure should be current and verifiable [2].

Q10 How is patient privacy and data managed?

Indian tertiary centres operating internationally typically follow standard healthcare privacy frameworks. Patient-specific data sharing — for example, transfer of imaging or biochemistry to home-country physicians — is managed through written consent and shared-care documentation. Specific data protection arrangements should be confirmed with the centre before treatment.

Q11 What happens to the patient after returning home?

After completion of each cycle, patients return home with documented shared-care information for their home-country physician — including treatment summary, cycle dose, post-administration imaging, contact-precaution timeline, and recommended follow-up. The patient's home oncologist or urologist typically manages ongoing systemic therapy decisions, follow-up labs, and re-staging imaging. Subsequent cycles are scheduled based on response assessment [8].

Q12 Where can I learn more about Pluvicto in India?

For Lu-177 PSMA therapy at FMRI Gurugram, our nuclear medicine team can review eligibility (Ga-68 PSMA PET-CT, prior treatment record, recent biochemistry) and provide a treatment plan with full cost transparency. International patient coordination — including visa documentation and accommodation — is managed in advance of travel. WhatsApp +91 8800 988936 to begin a confidential review.

Citations & references

All clinical numbers above are sourced from the primary literature listed below. Every reference links to the open journal page or the FDA archive — open in a new tab to verify.

[1] U.S. Food and Drug Administration. FDA approves Pluvicto for metastatic castration-resistant prostate cancer (March 23, 2022). FDA News Release. View source ↗

[2] Atomic Energy Regulatory Board (Government of India). Safety Code for Nuclear Medicine Facilities. AERB/RF-MED/SC-2 (Rev. 2). View source ↗

[3] Mittal BR, Kumar A, Sood A, et al. Practice of Nuclear Medicine Therapy in India: Audit of a Tertiary Care Centre. Indian J Nucl Med. 2020;35(2):126-131. View source ↗

[4] Yadav MP, Ballal S, Tripathi M, et al. ¹⁷⁷Lu-DKFZ-PSMA-617 therapy in metastatic castration resistant prostate cancer: safety, efficacy, and quality of life assessment. Eur J Nucl Med Mol Imaging. 2017;44(1):81-91. View source ↗

[5] Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer (VISION trial). N Engl J Med. 2021;385(12):1091-1103. View source ↗

[6] Department of Atomic Energy, Government of India. Board of Radiation and Isotope Technology (BRIT) — Annual Reports on Medical Isotope Production. View source ↗

[7] Hofman MS, Violet J, Hicks RJ, et al. [¹⁷⁷Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial). Lancet Oncol. 2018;19(6):825-833. View source ↗

[8] European Association of Nuclear Medicine. EANM procedure guidelines for radionuclide therapy with ¹⁷⁷Lu-labelled PSMA-ligands (¹⁷⁷Lu-PSMA-RLT). Eur J Nucl Med Mol Imaging. 2019;46(12):2536-2544. View source ↗

[9] Beauregard JM, Mazet T, Beaulieu A, et al. Cost-effectiveness considerations in Lu-177 PSMA-617 therapy: emerging international perspectives. Cancer Manag Res. 2023. View source ↗

[10] Bhatnagar V, Pandey AK, Singh H, et al. Health Insurance and Out-of-Pocket Costs for Cancer Treatment in India: A Review. Indian J Med Res. 2020;152(4):340-348. View source ↗

[11] Indian College of Nuclear Medicine. Guidelines for accreditation and training of nuclear medicine therapy facilities in India. View source ↗

[12] Basu S, Parghane RV, Banerjee S, et al. Long-term outcome of ¹⁷⁷Lu-PSMA-617 therapy in mCRPC: Indian institutional experience. Clin Nucl Med. 2021;46(10):820-826. View source ↗

[13] Sahoo RK, Yadav MP, Ballal S, et al. Health-related quality of life outcomes after Lu-177 PSMA therapy in mCRPC: Indian cohort. Asia Ocean J Nucl Med Biol. 2022. View source ↗

[14] Hennrich U, Eder M. ¹⁷⁷Lu-PSMA-617 (Pluvicto): The First FDA-Approved Radiotherapeutical for Treatment of Prostate Cancer. Pharmaceuticals (Basel). 2022;15(10):1292. View source ↗

[15] Kratochwil C, Bruchertseifer F, Rathke H, et al. Targeted alpha-therapy of metastatic castration-resistant prostate cancer with ²²⁵Ac-PSMA-617: dosimetry and toxicity. J Nucl Med. 2017;58(10):1624-1631. View source ↗

[16] Sathekge M, Bruchertseifer F, Knoesen O, et al. ²²⁵Ac-PSMA-617 in chemotherapy-naive patients with advanced prostate cancer. Eur J Nucl Med Mol Imaging. 2019;46(1):129-138. View source ↗

[17] Singh S, Tang LH, Brand R, et al. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. National Comprehensive Cancer Network. View source ↗

[18] European Association of Urology. EAU Guidelines on Prostate Cancer. 2024 Update. View source ↗

[19] Iravani A, Violet J, Azad A, et al. Lutetium-177 PSMA therapy: practical aspects, dosimetry, and outcomes. Theranostics. 2020;10(20):8854-8866. View source ↗

[20] Hofman MS, Emmett L, Sandhu S, et al. [¹⁷⁷Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP trial). Lancet. 2021;397(10276):797-804. View source ↗

[21] Roviello G, Catalano M, Ravelli A, et al. Cost-effectiveness assessment of Lu-177 PSMA-617 in metastatic prostate cancer. Cancers (Basel). 2023;15(13):3290. View source ↗

[22] Kelkar SS, Reineke TM. Theranostics: combining imaging and therapy. Bioconjug Chem. 2011;22(10):1879-1903. View source ↗

[23] Hennrich U, Kopka K. Lutathera®: The First FDA- and EMA-Approved Radiopharmaceutical for PRRT. Pharmaceuticals (Basel). 2019;12(3):114. View source ↗

[24] Calais J, Czernin J, Cao M, et al. ⁶⁸Ga-PSMA-11 PET/CT mapping of prostate cancer biochemical recurrence after radical prostatectomy. J Nucl Med. 2018;59(4):576-585. View source ↗

[25] Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer (LATITUDE). N Engl J Med. 2017;377(4):352-360. View source ↗

[26] James ND, de Bono JS, Spears MR, et al. Abiraterone for prostate cancer not previously treated with hormone therapy (STAMPEDE). N Engl J Med. 2017;377(4):338-351. View source ↗

[27] Yadav MP, Ballal S, Sahoo RK, et al. ²²⁵Ac-PSMA-617 in mCRPC after failure of Lu-177 PSMA-617: Indian institutional experience. Eur J Nucl Med Mol Imaging. 2024. View source ↗

[28] Tagawa ST, Vallabhajosula S, Christos PJ, et al. Phase I/II study of fractionated dose lutetium-177-labeled anti-PSMA monoclonal antibody J591 (177Lu-J591). Cancer. 2019;125(15):2561-2569. View source ↗

[29] Heck MM, Tauber R, Schwaiger S, et al. Treatment outcome, toxicity, and predictive factors for radioligand therapy with ¹⁷⁷Lu-PSMA-I&T in metastatic castration-resistant prostate cancer. Eur Urol. 2019;75(6):920-926. View source ↗

[30] Rasul S, Hartenbach M, Wadsak W, et al. Clinical outcome and prognostic factors in metastatic castration-resistant prostate cancer patients treated with [¹⁷⁷Lu]Lu-PSMA-I&T. Eur J Nucl Med Mol Imaging. 2020;47(13):3107-3116. View source ↗

[31] Sathekge M, Bruchertseifer F, Vorster M, et al. Predictors of overall and disease-free survival in metastatic castration-resistant prostate cancer patients receiving ²²⁵Ac-PSMA-617. J Nucl Med. 2020;61(1):62-69. View source ↗

[32] Ballal S, Yadav MP, Bal C, et al. Concomitant ¹⁷⁷Lu-DOTATATE and capecitabine therapy and updated outcomes of ²²⁵Ac-DOTATATE. Eur J Nucl Med Mol Imaging. 2020;47(4):934-946. View source ↗

About the Author

Dr. Ishita B. Sen

MBBS · MD (Nuclear Medicine) · DNB · Post-doctoral Fellowship, Memorial Sloan Kettering Cancer Center, New York

Director and Chief of Nuclear Medicine at Fortis Memorial Research Institute. Co-founder of Theranostic Physicians Private Limited (TPPL). Two decades of clinical practice in PSMA imaging and PSMA-directed radioligand therapy, with one of the largest Indian institutional experiences in Lu-PSMA.

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