Updating international standards for pharmaceutical waters

The selection of drugs for inclusion in the National Formulary has been made taking into consideration the relative advantages and disadvantages of the various drugs used, the extent of their use in current medical practice and their availability in the country.Thus the National Formulary of India represents a broad consensus of medical opinion in respect of drugs and their formulations and provides the physician with carefully selected therapeutic agents of proved effectiveness which form the basis of national drug therapy. Certain monographs require the use of a chemical reference substance or a biological reference preparation or a reference spectrum These are authentic specimens chosen and verified on the basis of their suitability for intended use as prescribed in the Pharmacopoeia and are not necessarily suitable in other circumstances.IP Reference Substances, abbreviated to IPRS (and referred to as RS in the individual monographs) are issued by the Indian Pharmacopoeia Commission (IPC).They are the official standards to be used in cases of arbitration.The criteria to be adhered are: The interpretation of a monograph must be in accordance with all the general requirements, testing methods, texts and notices pertaining to it, in the IP.

The technical group leaders at Ph RMA and USP realized the potential to take advantage of these process analytical measurements and use them for greater and more productive means.IP prescribes standards for identity, purity and strength of drugs essentially required from health care perspective of human beings and animals.IPC also provides IP Reference Substances (IPRS) which act as a finger print for identification of an article under test and its purity as prescribed in IP.The potency of these preparations is expressed in International Units.Analytical Research and Development (AR&D) Division firmly reinforces the mission and vision of IPC by bringing highest standards of drugs through its dynamic research activities.

Leave a Reply