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MoU to facilitate regulatory process for biosimilars
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SME Times News Bureau | 29 Apr, 2019
Council of Scientific and Industrial Research's constituent laboratory,
the Centre for Cellular and Molecular Biology (CSIR-CCMB), Hyderabad,
and the Indian Pharmacopeia Commission (IPC), Ghaziabad, have joined
hands to facilitate the regulatory process for biosimilars and herbal
drugs, as per a statement here on Sunday.
The scope of the
memorandum of understanding (MoU) signed between CSIR-CCMB and the IPC
is the development of biopharmaceutical reference standards and
impurities therein, development of monographs for important Monoclonal
Antibodies and identification of herbal drugs based on DNA Barcode
analysis, a CCMB statement said.
Use of biologics - biological
products that function as drugs against diseases - also known as
biosimilars, are expanding their presence rapidly in the healthcare
sector, including in India.
A 2017 report by the Confederation of
Indian Industry (CII) predicts that the biosimilars market in India,
that is currently worth about Rs 15,000 crore, is expected to cross the
staggering Rs 2,50,000 crore-mark by 2030.
Emergence of
biopharmaceutical drugs as a preferred choice for therapy over
conventional pharma drugs, requires concerted efforts by various sectors
within the country towards production, characterisation and validation
of indigenously developed products, the CCMB said.
The agreement was signed by CSIR-CCMB Director Rakesh Mishra and IPC's Secretary-cum-Scientific Director G.N. Singh.
This
collaboration, which has come into force with immediate effect, is very
important in the current scenario owing to the increase in use of
therapeutic proteins and herbal drugs for various diseases, the
statement said.
Documentation and characterisation of Indian
herbal drugs and phytopharmaceuticals will lead to a significant usage
and their export.
This collaborative project will be executed at par with pharmacopeia standards of other countries, it said.
Scientific
validation and characterization of herbal drugs will not only help
authentication of such drugs but also will bring credibility for this
industry, the CCMB added.
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