Indian Pharmacopoeia Commission (IPC) is in the process of expanding its operations at Ghaziabad to facilitate services to develop reference substance for biological products. The capacity building initiative is being spearheaded by the commission to ensure that India too can create ideal monographs and reference substances that will provide high quality standards for biological products that are manufactured within the country.

IPC will be expanding its facility at Ghaziabad by setting up a separate centre specifically dedicated to conduct research and analyses along with storing biological reference substances. This initiative was taken by the commission after realising the urgent need to develop IP reference substance for rDNA therapeutic products.

According to Dr Anurag Rathore member of the  the IPC, “Developing reference substance for the biological products is among one of the commissions important agenda. To focus on developing this area, IPC has already constituted a committee for biologics under the aegis of which lot of activities are being conduced actively. In fact we are considering to closely work with the USP on this front, so that we can share ideas and work together to develop our own reference substances in the near future.”

He pointed out that IPC is currently working towards revising the existing monographs of the rDNA model in lines of the international standards and developing new monograph as well so that even India can produce biological products that are of high standards ensuring patient safety at its best.

The commission will also be developing laboratory facility for the same at the IPC centre as it is critical for verifying the methodologies and limits of the new reference substances. Dr Rathore pointed out, “IPC's vision is to be a useful player in creating and establishing new standards for biotech drugs. As a creator of standards for biotech drugs in the country, we want to play a critical role by adopting science and risk based approach for the creation and modernisation of technological platform to support regulatory requirement.”

He emphasised that creating ideal monographs and reference substances for biological products is essential as they give assurance of adequate quality of the medicines throughout the time that it is available to the patients. Most importantly, it is essential as it also helps in guiding the DCGI's office to keep a track on the quality of the medicines that are produced in the country.