IPC issues clarification on alternative medicine in IP with reference to use of alternative methods

Mumbai, February 20, 2023 :

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.

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.

As per alternative methods, 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.

Automated procedures utilising 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 authorise manufacture of substance or product.

“For removal of doubts, it is clarified that the authority competent to authorise manufacture 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 and approval. All concerned are requested to bring the above clarification to the notice of all authorities under their control,” according to Dr Rajeev Singh Raghuvanshi, secretary-cum-scientific director, IPC.

IPC is an autonomous institution of the Union ministry of health. It is created to set standards of drugs in the country. Its basic function is to regularly update the standards of drugs commonly required for treatment of diseases prevailing in this region. It publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia.

It further promotes rational use of generic medicines by publishing National Formulary of India. IP prescribes standards for identity, purity and strength of drugs essentially required from the health care perspective of human beings and animals.

IPC also provides IP Reference Substances (IPRS) which act as a fingerprint for identification of an article under test and its purity as prescribed in IP. Pharmabiz