The Indian Pharmacopoeia Commission (IPC) is planning to supply certified IP Reference Substances (IPRS) to the scientist community and the industry for the first time, starting with ensuring availability of 150 most commonly required reference substances within a month's time, it is learnt.
The IPC, which released the 2010 edition of Indian Pharmacopoeia (IP) by the beginning of the month, will release the certified IPRS, the highly characterized specimens of drug substances for quality assurance, during a scientific body meeting to be held on August 21, 2010.
Out of the 150 chemical reference substances, identified as critically required for the country, 30 are to be certified and released for the first time anywhere in the globe and thus setting a benchmark for reference substance standard for these products world-over, said reliable sources from the commission.
The reference substances listed for release would be ready for issuance to the industry before the end of 2010, while the IPC is planning to add around 200 chemical reference substances as certified every year in near future. The aim is to make about 90 per cent of the reference substances available indigenously by 2012.
The reference substances identified are for the IPs approved in a period between 2007 and 2010, while the reference substances based on the latest IP 2010 would follow the suit soon, informed sources. The commission has further collected 250 most common clinical reference materials from the industry and conducting suitability studies to add with the currently certified reference substances.
At present, the IPRS available with the commission are restrained for reference to a limited group of users, even as the release of these substances by end of this month would make them available for the industry to buy for in-house utility.
Further, in an effort to accelerate the process of preparation, certification and distribution of IPRS, the IPC would integrate the responsibilities of Indian Foundation for Pharmaceutical Reference Standard Substances (IFPRESS) with the commission in due course of time. 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.