LSHC Horizons Brochure 2024 - Flipbook - Page 62
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | APAC
Cell, tissue, and gene therapy opportunities in India
With the rising burden of chronic diseases,
there is an increasing demand for innovative
therapeutic approaches. India is emerging as
a key player in the field of advanced medical
treatments, given the available skilled scientific
workforce and infrastructure resources.
This is particularly true in the realm of cell
and gene therapies.
Government support and private sector
investment have helped advance developments
in cell and gene therapies in India. For
example, the Government of India is
increasingly pushing towards conducting
increased numbers of clinical trials in India.
The Indian Council of Medical Research in
2019 issued the National Guidelines for Gene
Therapy Product Development and Clinical
Trials, which specifies the ethical, scientific,
regulatory procedures, and requirements to be
followed for developing and conducting clinical
trial on gene therapy products in India. These
guidelines were framed with reference to the
U.S. FDA and EU guidelines on gene therapy.
Kaustubh George
Counsel
Singapore
Several clinical trials are currently being
conducted in gene therapy for diseases such
as hemophilia A, B-cell acute lymphoblastic
leukemia, type-2 spinal muscular atrophy, and
B-cell lymphoma, among others. Recently,
in October 2023, India’s first indigenously
developed Chimeric Antigen Receptor
T-cell (CAR-T cell) therapy earned approval
from the Central Drugs Standard Control
Organization, India’s regulatory body for
pharmaceuticals and medical devices. In the
last few years, several products and procedures
for oncology, immunocompromised diseases,
and osteoarthritis have also been launched by
Indian biopharmaceutical companies.
Considering that cell and gene therapies are
still relatively nascent in India compared
with the evolved approach in the United
States and European Union, in particular,
ongoing dialogue with regulators and industry
participants at each stage of the product
development process will facilitate advances
in these technologies. Further, regulators and
biopharmaceutical manufacturers in India
can also take guidance from the already wellestablished FDA and European Medicines
Agency guidance for compliance of
such products.
Utkarsh Mishra
Senior Associate
Singapore
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