Indian Pharmacopoeia 2014 Pdf 54
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According to the PDG, in recent years it has addressed emerging drug quality issues such as the potential for impurities and reaching consensus on harmonisation of select pharmacopoeial standards. This has included standards for chromatography and dynamic light scattering to help ensure medical product quality.
In recent past (May 2022), regulatory authorities asked mfg to perform nitrosamine testing. But limited analytical testing capabilities and cost aspects acted as big barriers for mfg specifically small and medium mfg selling products locally. Even many state regulators laboratories currently lack required analytical capabilities. But nitrosamine impurities inclusion for sartan APIs monographs and voluntary for other drugs in Indian Pharmacopoeia 2022, regulators hinted for eventual compliance requirements in coming years for indian maket.
Background: This article emphasise on the Journey of Indian Pharmacopoeia and its parent organisation, the Indian Pharmacopoeia Commission (IPC) as setting up standards for maintaining the efficacy and quality of drugs used for the treatment of diseases prevailing in India. This study attempts to explore Indian Pharmacopoeial growth and general awareness among the scientists, research scholars, drug manufacturers, testing laboratories, healthcare professionals and other stakeholders for their compliance and usage. This article describe the functions of IP Commission such as revision and publication of the Indian Pharmacopoeia, addendum, National formulary of India on a regular basis also providing IP Reference Substances and professional training to the stakeholders on pertaining the Pharmacopoeial work.
Objectives of the Study: The objectives of the study are as follows:
i. To increase awareness about the Indian Pharmacopoeia (IP) and National Formulary of India (NFI) among the stakeholders; ii. To highlight the Pharmacopoeial importance in India; iii. To discuss landscape for safety and efficacy of the medicines; iv. To explore the journey of the Indian Pharmacopoeia (IP) and National Formulary of India (NFI).
Research Methodology: This article has been brought out on the basis of evaluation of pharmacopoeial publications and recent literature published online relevant to the drug and pharmaceuticals and it is a kind of descriptive study. There is a shortage of previous similar studies observed on Pharmacopoeial importance and its compliance. It is an attempt being made to understand the drug standardization for rational use of medicine in India.