Nagpur: The Union Budget for the fiscal year 2026-27 has been hailed as a significant stride toward achieving genomic and biopharmaceutical self-reliance for India. However, according to Dr Mayuri Yeole, a prominent clinical geneticist based in Nagpur, the financial blueprint falls short of addressing crucial deficiencies in the care and support for rare disease patients across the nation.
A Structural Shift from Generics to Genomics
In an exclusive conversation with TOI, Dr Yeole highlighted a transformative trend in India's pharmaceutical landscape. "For decades, India earned the title 'pharmacy of the world' due to its unparalleled dominance in generic medicines production," she remarked. "What we are witnessing today represents a fundamental structural shift—moving decisively from generics to genomics." This observation directly references the ambitious ₹10,000-crore Biopharma SHAKTI initiative unveiled in the recent Budget announcement.
Immediate Relief Through Customs Duty Exemptions
The Budget introduced specific measures aimed at providing financial respite to affected families. It expanded customs duty exemptions to cover seventeen critical cancer and advanced-therapy drugs. Furthermore, duty-free imports were extended to include essential medicines and specialized nutritional products required for treating seven distinct rare diseases.
Dr Yeole acknowledged these steps as offering "some immediate financial relief" to countless families grappling with rare genetic disorders. Many of these families depend heavily on imported treatments, which can incur annual costs running into several crores of rupees, placing an immense economic burden on households.
"Eliminating customs duties is a pragmatic and necessary intervention," she stated. "It recognizes the overwhelming financial strain endured by families who frequently deplete their life savings or resort to public fundraising campaigns to afford these life-saving therapies."
Systemic Challenges Beyond Cost Reduction
Despite this positive development, Dr Yeole issued a cautionary note, emphasizing that reducing costs alone cannot resolve deeper, systemic healthcare challenges. "From a clinical perspective, duty exemptions constitute only a partial solution," she explained. "They do not inherently guarantee patient access to treatments, ensure continuity of comprehensive care, or provide long-term affordability assurances."
She pointed out that the Budget remained firmly anchored to the existing National Policy for Rare Diseases (NPRD) established in 2021. Notably, it failed to introduce innovative funding mechanisms or guaranteed financial support structures specifically tailored for advanced therapies required by rare disease patients.
Long-Term Vision for Biopharma and Biotechnology
Where the Budget truly distinguished itself, according to Dr Yeole, was in its forward-looking vision for the biopharma and biotechnology sectors. The five-year, ₹10,000-crore commitment dedicated to biologics, biosimilars, advanced therapeutics, regulatory capacity enhancement, and clinical trial infrastructure development holds transformative potential for rare disease care in India.
"The majority of rare genetic disorders today are managed not with conventional pharmaceutical drugs, but through sophisticated treatments like enzyme replacement therapies, biologics, and gene-based interventions," she elaborated. "Cultivating indigenous manufacturing and research capacity is absolutely essential if India aims to transition away from importing prohibitively expensive therapies toward developing affordable, locally relevant solutions."
Potential Downstream Impacts and Execution Imperatives
Dr Yeole elaborated that strengthening domestic biopharma capabilities could yield multiple benefits:
- Reducing dependence on costly imports
- Streamlining regulatory approval pathways
- Aligning scientific research with India's vast and unique genetic diversity
The downstream impact on genomics and pharmacogenomics could be particularly significant, potentially enabling:
- Earlier and more accurate diagnoses
- Improved access to clinical trials
- Development of therapies closer to patients' communities
However, Dr Yeole issued a clear warning: ambitious investment must be matched with meticulous execution. "Biopharma investment initiatives must proceed hand-in-hand with strengthening diagnostic infrastructure, enhancing clinician training programs, expanding genetic counseling services, and integrating genomics into routine healthcare delivery," she asserted. "Without this holistic approach, scientific innovation risks remaining disconnected from clinical reality and patient needs."
A Clear Signal and the Path Forward
According to Dr Yeole's analysis, the Budget sends an unequivocal signal that rare diseases and advanced therapeutics have finally entered India's national health policy conversation in a meaningful way. "The real and pressing challenge now is ensuring that policy intent translates into equitable, tangible outcomes for all citizens," she concluded. "This is especially critical for patients with rare genetic disorders, whose medical needs are often urgent, complex, and historically overlooked in broader healthcare planning."
