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Social Issues May 05, 2026 6 min read Daily brief · #18 of 28

India should chart own path in treatment of rare diseases: ICMR chief

The Director General of the Indian Council of Medical Research (ICMR), Dr. Rajiv Bahl, has called for India to develop an indigenous model for the diagnosis,...

GS Paper 2 (Social Justice Health)

What Happened

  • The Director General of the Indian Council of Medical Research (ICMR), Dr. Rajiv Bahl, has called for India to develop an indigenous model for the diagnosis, treatment, and prevention of rare diseases rather than adopting frameworks designed for resource-rich Western healthcare systems.
  • The approach advocated emphasises resource optimisation, indigenous pharmaceutical innovation, preventive strategies, and the use of digital technologies — including artificial intelligence for early detection and expanded outreach — to address rare diseases within India's healthcare infrastructure constraints.
  • The need for addressing rare diseases was first formally recognised in the National Health Policy, 2017, and was subsequently institutionalised through the National Policy for Rare Diseases, 2021 (NPRD 2021), which provides a comprehensive framework for categorisation, treatment, and financial assistance.
  • Since the NPRD 2021, the number of designated Centres of Excellence (CoEs) for rare disease diagnosis and care has expanded from 8 to 15, including two in northeast India.
  • Financial assistance under the policy has been progressively enhanced to ₹50 lakh per eligible patient for specific categories of rare diseases treated at designated CoEs.
  • India's rare disease burden is estimated at approximately 95 million patients, making indigenous solutions a matter of scale and public health urgency.

Static Topic Bridges

National Policy for Rare Diseases, 2021 — Framework and Categorisation

The NPRD 2021 is India's primary policy instrument for addressing the diagnostic, therapeutic, and financial challenges posed by rare diseases.

  • Administered by: Ministry of Health and Family Welfare (MoHFW).
  • Three disease categories under NPRD 2021:
  • Group 1: Disorders amenable to a one-time curative treatment (e.g., Gaucher's disease, some metabolic disorders). Financial assistance of up to ₹50 lakh available under the Rashtriya Arogya Nidhi (RAN) umbrella scheme.
  • Group 2: Diseases requiring long-term or lifelong treatment but at relatively lower cost, with documented treatment benefit and need for periodic surveillance.
  • Group 3: Diseases for which definitive treatment exists but challenges remain around patient selection, very high cost, and lifelong therapy requirements.
  • Eligibility for financial support: Not limited to Below Poverty Line (BPL) families — extended to approximately 40% of the population eligible under PM Jan Arogya Yojana (Ayushman Bharat).
  • Centres of Excellence (CoEs): 15 designated institutions across India (as of 2026); each CoE received up to ₹5 crore for upgradation of diagnostic facilities.
  • ICMR's role: Apex biomedical research body coordinating the National Rare Disease Registry, research on indigenous diagnostics and treatments, and technical guidance for CoEs.

Connection to this news: The ICMR Chief's call for an indigenous path directly addresses a limitation of the NPRD 2021 — that it is largely modelled on Western rare disease frameworks, which assume high pharma-industry participation through orphan drug incentives and high per-patient spending that is unsustainable at India's scale.

ICMR — Mandate and Role in Public Health

The Indian Council of Medical Research (ICMR) is the apex body for biomedical and health research in India.

  • Established: 1911 (as Indian Research Fund Association); renamed ICMR in 1949.
  • Administrative control: Ministry of Health and Family Welfare.
  • Mandate: Formulate, coordinate, and promote biomedical research; translate research findings into health policy; support disease surveillance, vaccine development, and clinical trials.
  • Key contributions: Development of indigenous diagnostics (including RT-PCR kits for COVID-19), coordination of clinical trial networks, National Rare Disease Registry (under ICMR's National Institute of Medical Statistics).
  • ICMR and rare diseases: Operates the Rare Diseases Research Database (RDRDB) to map disease prevalence, coordinate research, and support CoEs.
  • ICMR's role in rare diseases bridges research (disease characterisation, biomarker development) and policy (informing treatment guidelines for NPRD 2021).

Connection to this news: The ICMR DG's statement is an institutional call for the country's apex medical research body to lead the development of affordable, indigenous rare disease diagnostics and therapeutics — shifting dependence away from imported, unaffordably priced treatments.

Orphan Drug Policy — The Global Model and India's Gap

An "orphan drug" is a pharmaceutical developed for rare diseases — so named because the small patient population makes such drugs commercially unattractive without regulatory incentives.

  • US Orphan Drug Act, 1983: Landmark legislation providing tax credits, market exclusivity (7 years), and expedited FDA review for drugs targeting diseases affecting fewer than 200,000 people. Transformed rare disease drug development globally.
  • EU Orphan Regulation, 2000: Similar incentives; 10-year market exclusivity, fee waivers, scientific assistance.
  • India's gap: India does not have a dedicated Orphan Drug Act. The Drugs and Cosmetics Act, 1940 (and Rules thereunder) lacks specific incentives for orphan drug development or manufacturing.
  • The absence of an Indian orphan drug framework means domestic pharma companies — including Biological E and the Serum Institute — have limited financial incentive to invest in rare disease product pipelines.
  • Imported rare disease drugs are often priced at ₹50 lakh–₹10 crore per patient per year — effectively unaffordable even for upper-middle-class families without insurance.
  • India's generic pharmaceutical manufacturing strength offers a theoretical pathway to produce orphan drugs at lower cost, but regulatory pathways need adaptation.

Connection to this news: ICMR's call to "chart an own path" implicitly addresses the orphan drug gap — India cannot replicate the US/EU model that relies on high per-patient pricing to recoup R&D costs. An Indian model must leverage generic manufacturing, public R&D funding, and population-based prevention to make rare disease treatment accessible.

National Health Policy, 2017 — Role in Setting Rare Disease Agenda

The National Health Policy (NHP) 2017 was the first comprehensive health policy document that formally acknowledged the need for a rare disease framework.

  • NHP 2017 set a vision of "Health and Wellbeing for All at All Ages" — a shift from disease control to holistic health outcomes.
  • It acknowledged the growing burden of Non-Communicable Diseases (NCDs), genetic diseases, and rare conditions.
  • NHP 2017 called for formulation of a National Rare Diseases Policy, which was subsequently fulfilled by NPRD 2021.
  • Key health targets in NHP 2017: raise public health expenditure to 2.5% of GDP (from ~1.15% at the time); reduce Under-5 Mortality Rate (U5MR) to 23/1000 live births; reduce infant mortality to 28/1000 live births.
  • NHP 2017 also emphasised the role of telemedicine, digital health records, and community health workers (ASHA, ANM) in expanding access — tools now being invoked by ICMR for rare disease outreach.

Connection to this news: The rare disease policy trajectory — NHP 2017 → NPRD 2021 → current ICMR call for indigenous pathways — illustrates how health policy in India evolves from broad acknowledgement to specific institutional frameworks and now to implementation-level innovation.

Key Facts & Data

  • Estimated rare disease patients in India: approximately 95 million
  • Global definition of rare disease: prevalence of fewer than 1 in 2,000 persons (EU definition); fewer than 200,000 patients (US Orphan Drug Act)
  • NPRD 2021 disease groups: 3 (Group 1: one-time curative; Group 2: long-term lower cost; Group 3: definitive but very high cost)
  • Financial assistance under NPRD 2021: up to ₹50 lakh per patient (Group 1, via Rashtriya Arogya Nidhi)
  • CoE (Centres of Excellence) for rare diseases: 15 (up from 8 at NPRD launch), including 2 in northeast India
  • CoE infrastructure grant: up to ₹5 crore per centre for diagnostic upgradation
  • ICMR established: 1911 (renamed 1949)
  • ICMR's administrative ministry: Ministry of Health and Family Welfare
  • US Orphan Drug Act: 1983; EU Orphan Regulation: 2000; India: no equivalent legislation
  • NHP 2017 public health expenditure target: 2.5% of GDP
  • Rare disease drug import costs: ₹50 lakh – ₹10 crore per patient per year (approximate range)
  • PM Jan Arogya Yojana coverage (rare disease financial aid): approximately 40% of population
On this page
  1. What Happened
  2. Static Topic Bridges
  3. National Policy for Rare Diseases, 2021 — Framework and Categorisation
  4. ICMR — Mandate and Role in Public Health
  5. Orphan Drug Policy — The Global Model and India's Gap
  6. National Health Policy, 2017 — Role in Setting Rare Disease Agenda
  7. Key Facts & Data
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