Last Updated on October 10, 2024 by The Health Master
The Indian Pharmacopoeia Commission (IPC) has issued clarification on alternative medicine in the Indian Pharmacopoeia (IP) with reference to the use of alternative methods instead of official methods.
To read or download the clarification from IPC, click here
IPC has been receiving many enquiries on the subject of the use of alternative methods instead of official methods included in the IP.
General Notices of IP (Volume I, Page 12) have the provision to use alternative methods and the same has been reproduced and described.
Alternative methods are the tests and assays described are the official methods upon which the standards of the pharmacopoeia are based.
Alternative methods of analysis may be used for control purposes provided that the methods used are shown to give results of equivalent accuracy and enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were used.
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Automated procedures utilizing the same basic chemistry as the test procedures given in the monograph may also be used to determine compliance.
Such alternative or automated procedures must be validated and are subject to approval by the authority competent to authorize manufacturer of substance or product.
“For removal of doubts, it is clarified that the authority competent to authorize manufacturer of substance or product as mentioned above in the General Notices of IP refers to the licensing authority, either State or Central Drug Regulatory Authority as the case may be, for grant of license or approval.
All concerned are requested to bring the above clarification to the notice of all authorities under their control,” as per the IPC notice.
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