The United States Pharmacopeial Convention (USP), a standards-setting authority for prescription and over-the-counter medicines, is creating supporting standards and reference material for chemical and biological products. USP is in the process of updating its formulary, which is related to biologics and biotechnology, and working specifically on cell, gene and tissue therapies.
A formulary is a collection of formulas for the compounding and testing of medicines. The main function of formularies is to specify medicines approved for prescription under a particular contract. The development of formularies is based on evaluations of efficacy, safety and cost-effectiveness of drugs. Depending on the individual formulary, it may also contain additional clinical information, such as side-effects, contraindications and doses.
?We are now poised to do more collaborative testing, verification and sourcing for written and physical standards for drugs,? said Roger L Williams, CEO, USP. ?An updated chapter on cell and gene therapy products and other requirements for manufacturing and testing of tissue and modified cell products are currently being revised,” he said. He added that USP was looking at the requirements for manufacturing and testing of gene-modified cell products.
Williams, who was in Hyderabad to inaugurate the $14-million USP?s India office, said that this office would initially provide support towards developing the standards for vaccines expected to be launched in a year or so. It is also working on a medicine compendium for therapeutic proteins and polysaccharides as well.
Meanwhile, the USP-India office has signed a memorandum of understanding with the Indian Pharmacopoeia Commission (IPC), to promote the development of documentary standards and physical reference materials for the global chain. In fact, IPC said, it had set itself a mandate to increase the number of monographs from the current 1,900 to 3,000 over the next five years. It has also decided to augment the number of reference substances from the current 120, apart from strengthening laboratories and manpower across the country.
IPC chairman B Suresh said the US Pharmacopeia, whose standards are recognised in over 130 countries, has over 4,000 monographs. A monograph details the protocols to be followed while producing a particular drug, besides giving information about its quality, purity, safety and identity.
USP is also planning to launch a national formulary in October and increase the number of pharmacovigilance centres to 100, from the current 40, over the next few years by strengthening medical institutions. The idea is to identify and record adverse drug reactions in the market place. In the last one year, they have added over 15,000 records and, going further, would further widen their database, Suresh added.