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CSIR-CCMB and IPC join hands to facilitate regulatory process for biosimilars

Hyderabad: The Centre for Cellular and Molecular Biology (CCMB), Hyderabad, a constituent laboratory of Council of Scientific and Industrial Research (CSIR), New Delhi, and Indian Pharmacopeia Commission (IPC), Ghaziabad, have signed an MoU towards the development of biopharmaceutical Reference standards & impurities therein,

Development of Monographs for important Monoclonal Antibodies and Identification of herbal drugs based on DNA Barcode analysis.

The agreement was signed by Dr. Rakesh Mishra, Director, CSIR-CCMB and Dr. G N Singh, Secretary-cum-Scientific Director, IPC.

This collaboration, which is in 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. Documentation and characterization of Indian herbal drugs, the phytopharmaceuticals, will lead to a significant usage and their export.

This collaborative project will be executed at par with pharmacopeia standards of other countries. Scientific validation and characterization of herbal drugs will not only help authentication of such drugs but also will bring credibility for this industry and make the traditional knowledge of thousands of years.

Bring into the purview of modern scientific methods will facilitate regulatory process and give a much needed boost to this industry.

Use of biologics, the biological products that functions as drugs against diseases, also known as biosimilars, are rapidly expanding their presence in healthcare sector, including in India.

In fact, a 2017 report of the Associated Chambers of Commerce of India (CII) report predicts that the biosimilars market in India that was worth about Rs.15 thousand crore is expected to cross an astonishing Rs. 250 thousand crore mark by 2030.

Emergence of biopharmaceutical drugs as a preferred choice for therapy over the conventional pharma drugs, requires concerted efforts by various sectors within the country towards production, characterization and validation of indigenously developed products. To meet this challenge, the CCMB-CSIR and IPC have signed this MoU. (INN)

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