The Indian Pharmacopoeia Commission (IPC) has announced release of 147 certified IP Reference Substances (IPRS) for the first time, reducing the cost of these reference substances substantially for the scientist community and the pharma industry in the country, compared to those imported from World Health Organisation (WHO) or United States Pharmacopoeia (USP).
Out of the 147 most commonly required reference substances released, 40 are directly supplied by the IPC and almost 107 reference substances through the Indian Foundation for Pharmaceutical Reference Standard Substances (IFPRESS), the organisation working in the area for last several years and soon to be integrated to the commission, according to a senior official from IPC. Till now, the IPRS available with the commission was restricted only to a limited group of users, for reference.
At present, the industry relies more on imported reference substances for their products to cross check with the pharmacopoeial standards. The reference substances released by the IPC, is expected to reduce the cost spend by companies on reference substances by five to eight times from the current cost, said the source.
For the time being, the 40 IPRS released by IPC would be available with the commission's office at Ghaziabad and the rest of the 107 will be supplied by IFPRESS office. IFPRESS, an organisation to procure, test, certify and distribute IPRS for the industry to ensure the quality of active pharma ingredients and their formulations, is the Government of India approved supplier of IP reference standards, at present.
IPC's plans are to release more than 150 IP reference substances by the end of 2010. The IPC is also planning to add around 200 chemical reference substances as certified every year in near future and the aim is to make about 90 per cent of the reference substances available indigenously by 2012. The reference substances released are for the IPs approved in a period between 2007 and 2010, while the reference substances based on the latest IP 2010 would be released in near future.
As reported earlier, the commission has also collected 250 most common clinical reference materials from the industry and conducting suitability studies to add with the currently certified reference substances.