With a view to ensure availability of high quality medicines to the patients across the country, the Indian Pharmacopoeia Commission (IPC) is working towards adding up 72 new reference substances (RS) to the Indian Pharmacopoeia (IP) by March this year. With this addition, the total number of the IP reference substance would go up to 250 which they further plan to increase over the course of next five years as per the requirement of the country.
At present, there are 178 reference substances prepared by the IP, after meeting vigorous regulatory parameters as per the requirement and the needs of the country, which are used in analytical procedures of pharmaceutical substances for evaluating and enhancing the quality of medicines. It is understood in the next phase, IPC plans to include and make available most of the required reference substances within the IP, to enable India to manufacture pharma products that are accepted globally for ensuring patient safety. Roughly, IPC aims to add around 500 reference substances under its fold in the next five years time.
Since last year, IPC have been constantly working towards increasing the reference substances and monographs in the IP so as to strengthen and make it self sustained and globally acceptable standard setting body, at par with other international pharmacopoeias like USP, BP etc. IP reference substances consist of authentic specimens approved by the IPC for its use as comparison standards in the test and assays as specified to assist the drug regulatory body in the country in protecting public health.
Dr G N Singh, secretary cum scientific director of IPC informed that developing RS as per the needs of the country is a challenging job that requires a lot of expertise from the best in the field since it revolves around patient safety and well-being.
He further added, “The main mandate of the commission is to empower and build requisite IP reference substances that is aimed at benefiting all the stakeholders of the country while assuring quality of the medicines that are manufactured and moving through out India. Most importantly apart from developing confidence among the international trade, it will help us to be self sustain and independent. It will also save a lot of money from the government exchequer that otherwise is spend on getting access to reference substances developed by other pharmacopoeias.”
Dr Singh who is also the drug controller general of India (DCGI) stressed that creating ideal reference substances 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 regulators office to keep a track on the quality of the medicines that are produced in the country.