Ø Centre Expands Centrally License
Approving Authority (CLAA) Framework to Include Cell and Stem Cell-derived
Products, Gene Therapeutics and Xenografts
·
The
Central Government has amended the Drugs
Rules, 1945.
·
The
amendment brings advanced therapies under the Centrally License Approving Authority (CLAA)
framework.
The CLAA framework now
includes:
·
Cell
or Stem Cell-derived products
(e.g., regenerative therapies, CAR-T cell therapy).
·
Gene
therapeutic products
(e.g., gene replacement and gene editing therapies).
·
Xenografts (animal tissue-derived products such as
heart valves).
Previously, CLAA
regulated critical biological products such as:
·
Vaccines.
·
Large
Volume Parenterals (IV fluids above 100 ml).
·
Recombinant
DNA (r-DNA)-based medicines.
·
Strengthen
regulatory oversight of advanced and emerging medical technologies.
·
Ensure
greater patient safety.
·
Address
the complex and rapidly evolving nature of these therapies.
·
Stem
Cell and CAR-T therapies:
Treatment of blood cancers like leukemia and
lymphoma.
·
Gene
therapies:
Treatment of inherited genetic disorders and various cancers.
·
Xenografts: Used in cardiology (heart valves) and orthopedics.
·
Joint
oversight by Central and
State Licensing Authorities.
·
Uniform
regulatory standards across India.
·
Enhanced
regulatory scrutiny for advanced therapies.
·
Strengthened
regulatory framework aligned with scientific advancements.
·
Adoption
of global best practices.
·
Improved
public health protection.
·
Promotion
of innovation and faster adoption of advanced healthcare technologies.
The amendment expands
the CLAA framework to regulate cutting-edge therapies such as stem cell
products, gene therapies, and xenografts, ensuring uniform, rigorous, and
scientifically robust regulation while supporting innovation in India's
healthcare and life sciences sectors.
<Gazette Notification G.S.R.
530(E) dated 29.06.2026>
[ABS News Service/03.07.2026]
In a significant step towards
strengthening the regulatory oversight of advanced and emerging medical
technologies, the Central Government has amended the Drugs Rules, 1945 to bring
Cell or Stem Cell derived products, Gene therapeutic products and Xenografts
under the ambit of the Centrally License Approving Authority (CLAA) framework.
Under the Drugs and Cosmetics Act,
certain specified categories of critical drugs and biological products are
under the joint regulatory supervision of the Central and State regulators.
These include vaccines, large volume parenterals (IV
solutions > 100 ml) and r-DNA based medicines. This set is being expanded
with this amendment to cover additional emerging technologies.
Cell or Stem Cell derived products
e.g. such as stem cell-based regenerative treatments, CAR-T cell therapies have
seen increasing use in treatment of blood cancers such as leukemias
and lymphomas. Gene therapeutic products such as gene replacement and gene
editing products have found use in treating genetic disorders and various types
of cancers. Xenografts are animal tissue-derived products such as heart valves
which can be transplanted into humans. These have use in cardiology and orthopedics.
Since these technologies represent
highly complex, specialized and rapidly evolving areas of medical science, they
need enhanced regulatory scrutiny to ensure patient safety.
The inclusion of these products under
the CLAA framework will facilitate a system of joint oversight by the Central
and State Licensing Authorities, thereby ensuring uniformity in regulatory
standards across the country. The amendment will increase regulatory rigour for
emerging technologies and reinforcing India's regulatory framework in line with
scientific advancements and global best practices.
This initiative reflects the
Government's continued commitment towards safeguarding public health while
promoting innovation and quicker adoption of latest technologies in healthcare
and life sciences sectors.