Hyderabad: Regulatory standards for biosimilars and herbal drugs are to be developed by the city-based Centre for Cellular and Molecular Biology (CCMB) as they need to be monitored due to their high demand worldwide.
The market which is presently Rs 15,000 crore, is expected to peak at Rs 25 lakh crore by 2030.
The use of biopharmaceutical drugs for therapy is expected to take over conventional pharma drugs and for this reason close monitoring and regulatory framework is required.
Dr Rakesh Mishra, director, CCMB, said, “The increasing use of therapeutic proteins and herbal drugs requires proper clearance and documentation. The guidelines and rules for herbal drugs have to be framed as they are also being exported to other countries. Scientific validation and characterization will help us prove the authenticity of the drugs and also bring credibility to the industry.”
Biosimilars are biopharmaceutical drugs which have properties similar to those that are licenced and manufactured by other firms The CCMB, constituent laboratory of Council of Scientific and Industrial Research (CSIR), New Delhi, and Indian Pharmacopeia Commission, Ghaziabad, signed a memorandum of understanding towards the development of biopharmaceutical reference standards and impurities.
It also covers the development of monographs for important monoclonal antibodies and identification of herbal drugs based on DNA barcode analysis.
