HYDERABAD: A wide range of capsules, tablets and churans are sold across the country under the labels ‘herbal medicine’ and ‘ayurvedic medicine’. These are manufactured by a number of companies — ranging from the well-known to the never-heard-of. However, there is no organisation to certify the genuineness of these products.
Same is the case with biosimilars, which are expected to revolutionise the treatment of various diseases across the world. As per a Confederation of Indian Industry (CII) report, the biosimilar market in India is expected to cross the `2.5 lakh crore mark by 2030. However, there exists no concrete regulatory process to monitor the quality of biosimilars in India.
But the Hyderabad-based Centre for Cellular and Molecular Biology (CCMB) is set to change this, by playing a significant role in the regulation and quality-testing of both biosimilars and herbal medicines. The Centre recently signed a Memorandum of Understanding (MoU) with the Indian Pharmacopeia Commission in this regard.
The genuineness of herbal medicines will be tested in the same way DNA is used by forensic experts to identify wildlife species. The CCMB will develop DNA barcodes for this.
To ascertain the genuineness of herbal medicines, the Centre for Cellular and Molecular Biology (CCMB) plans to develop DNA barcodes for various species of medicinal plants. These barcodes will be used by the Indian Pharmacopeia Commission (IPC) to analyse herbal medicines, to check if they really contain the herbs they claim to be made of.
Speaking to Express, CCMB director Dr Rakesh Mishra said that they would initially develop DNA barcodes for around 30-40 common herbs, and later work on barcodes for up to 300-400 herbs.
For quality tests, the CCMB will help develop reference standards along with a mechanism to find impurities in biosimilars and develop monographs for monoclonal antibodies.
Dr Mishra pointed out that although the IPC has the required manpower and funds, it lacks technical expertise, and this is where the CCMB comes into the picture.The CCMB will not just train IPC personnel in quality-testing, but also help the IPC set up laboratories equipment for the same. This would not just help ensure good-quality herbal medicines and biosimilars in the country, but also pave the way for them to be exported across the world.