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THE PHARMA REVIEW (MARCH APRIL 2016)

Current Status and Future Challenges for Indian Pharmacopoeia

Jai Prakash1*, Manoj Kumar Pandey1, SK Gupta2, GN Singh1

Introduction: Keeping a check on the quality of drugs imported, manufactured, stocked or exhibited for sale or distributed etc. remains the need of the hour from the patient safety perspective. One of the important tools in India that can be used for such a check is Indian Pharmacopoeia, the regulatory document for standards of drugs in India. This review article focuses on significance of pharmacopoeial standards, legal status of Indian Pharmacopoeia, references to IP, chronology of publication of IP, salient features of IP 2014 and its Addenda 2015 and 2016, inclusion/exclusion criteria of drug monographs, IPRS and IP reference spectra, interpretation of a monograph, pharmacopoeial harmonization, mechanism for addressing IP related queries, differences between IP and NFI, and challenges ahead. It is expected to be useful to the stakeholders - industry, regulators, pharmaceutical teachers/researchers, students, drug analysts etc. The valuable feedback from stakeholders will help improvement of IP. 

 

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