STEM
CELLS AND CELL BASED PRODUCTS IN INDIA : REGULATORY
FRAMEWORK
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Dr. A. Ramkishan,
Deputy Drugs Controller,
CDSCO, East Zone, Kolkata |
Dr. A. Ramkishan, Deputy Drugs Controller (India),
Dr.Kamal Krishna Halder, Assistant Drugs Controller
(India),
Ashok Kumar, Drugs Inspector, CDSCO, East Zone, Kolkata
Background information:
Biological products can be defined according to their
source material and method of manufacture. The source
materials and methods employed in the manufacture of
biological products for human use therefore represent
critical factors in shaping their appropriate regulatory
control. Biological products are derived from cells,
tissues or microorganisms and reflect the inherent
variability characteristic of living materials. The
active substances in biological products are often too
complex to be fully characterized by utilizing
physicochemical testing methods alone and may show a
marked heterogeneity from one preparation and/or batch
to the next. Consequently, special considerations are
needed when manufacturing biological products in order
to maintain consistency in product quality. Good
manufacturing practices (GMP) for biological products
were first published by WHO in 1992 (1). This current
revision reflects subsequent developments that have
taken place in science and technology, and in the
application of risk-based approaches to GMP (2–14). The
content of this document should be considered
complementary to the general recommendations set out in
the current WHO good manufacturing practices for
pharmaceutical products: main principles (2) and in
other WHO documents related specifically to the
production and control of biological products.
The use of stem cells as medicines is a promising and
upcoming area of research as they may be able to help
the body to regenerate damaged or lost tissue in a host
of diseases like Parkinson's, multiple sclerosis, heart
disease, liver disease, spinal cord damage, cancer and
many more. Translating basic stem cell research into
routine therapies is a complex multi-step process which
entails the challenge related to managing the expected
therapeutic benefits with the potential risks while
complying with the existing regulations and
guidelines. While in the United States (US) and European
Union (EU) regulations are in place, in India, we do not
have a well-defined regulatory framework for "stem cell
based products (SCBP)". There are several areas that
need to be addressed as it is quite different from that
of pharmaceuticals. These range from establishing batch
consistency, product stability to product safety and
efficacy through pre-clinical, clinical studies and
marketing authorization. This review summarizes the
existing regulations/guidelines in US, EU, India, and
the associated challenges in developing SCBP with
emphasis on clinical aspects. The regulatory
requirements for stem cells in India are summarized as
follows:
Definition of New Drugs as per NDCT Rules, 2019
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a drug, including active pharmaceutical ingredient or
phytopharmaceutical drug, which has not been used in the
country to any significant extent, except in accordance
with the provisions of the Act and the rules made
thereunder, as per conditions specified in the labeling
thereof and has not been approved as safe and
efficacious by the Central Licensing Authority with
respect to its claims;
-
a drug approved by the Central licensing Authority for
certain claims and proposed to be marketed with modified
or new claims including indication, route of
administration, dosage and dosage form;
-
a vaccine, recombinant Deoxyribonucleic Acid (r-DNA)
derived product, living modified organism, monoclonal
anti-body, stem cell derived product, gene therapeutic
product or xenografts, intended to be used as drug;
“investigational new drug” means a new chemical or
biological entity or substance that has not been
approved for marketing as a drug in any country.
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The clarification of the Stem cell derived product is:-
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‘Stem Cell Derived Product’ means a drug which has been
derived from processed stem cells and which has been
processed by means of substantial or more than minimal
manipulation with the objective of propagation and / or
differentiation of a cell or tissue, ”cell activation
and production of a cell-line which includes
pharmaceutical or chemical or enzymatic treatment,
altering a biological characteristic, combining with a
non-cellular component, manipulation by genetic
engineering including gene editing & gene modification’.
-
a drug which has been derived from processed cells
including cell or tissue which has been processed by
means of substantial or more than minimal manipulation
-
with the objective of propagation and / or
differentiation of a cell or tissue,' cell activation,
and production of a cell-line,
-
which includes pharmaceutical or chemical or enzymatic
treatment, altering a biological characteristic, ü
combining with a non-cellular component,
-
manipulation by genetic engineering including gene
editing & gene
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Substantial or more than minimal manipulation means
ex-vivo alteration in the cell population (T-Cell
depletion, cancer cell depletion), expansion, which is
expected to result in alteration of function.
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The isolation of tissue, washing, centrifugation,
suspension in acceptable medium, cutting, grinding,
shaping, overnight culturing without biological and
chemical treatment, disintegration of tissue, separation
of cells, isolation of a specific cell, treatment with
antibiotics, sterilization by washing
or gamma irradiation, freezing, thawing and such
similar procedures, regarded as minimal manipulations
and are not considered as processing by means of
substantial or more than minimal manipulation.
-
Human cells or tissues removed from an individual for
implantation of such cells or tissues only into the same
individual for use during the same surgical procedure
should not undergo processing steps beyond rinsing,
cleaning or sizing and these steps shall not be
considered as processing.
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