MoU to facilitate regulatory process for biosimilars

Hyderabad: The biopharmaceutical industry received a big boost on Sunday with the city-based Council of Scientific and Industrial Research, Centre for Cellular and Molecular Biology (CSIR-CCMB) inking an agreement with India Pharmacopoeia Commission (IPC), Ghaziabad, to facilitate the regulatory process for biosimilars and herbal drugs.

The scope of the MoU is 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. Dr GN Singh, secretary-cum-scientific director, IPC signed the agreement for IPC.

Use of biologics — biological products that function as drugs against diseases — also known as biosimilars, is expanding rapidly in the healthcare sector, including in India. The biosimilars industry, which is worth Rs 15,000 crore, is expected to cross Rs 2.5 lakh crore mark by 2030, according to a 2017 report of Associated Chambers of Commerce of India.

“Emergence of biopharmaceutical drugs as a preferred choice for therapy over conventional pharma drugs requires efforts by various sectors within the country towards production, characterisation and validation of indigenously developed products,” said CCMB director Rakesh Mishra.

CCMB said the collaboration will come into force with immediate effe ct and this is important in the current scenario owing to increase in the use of therapeutic proteins and herbal drugs for the treatment of various diseases.

“Indian herbal drugs can be exported after proper standardisation and characterisation. The collaborative project will be executed based on pharmacopoeia standards of other countries. Scientific validation and characterisation of herbal drugs will not only help in authentication of such drugs but will also bring credibility to the industry,” Mishra said.