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The Union Health Ministry has recently released the 9th edition of Indian Pharmacopoeia (IP) 2022 containing 92 new monographs for drugs, 12 new general chapters, 1245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs) as well as dissolution specifications for all prolonged release formulations. Till date there are no such specifications for prolonged release formulations.

π“π‘πž 𝐈𝐧𝐝𝐒𝐚𝐧 𝐏𝐑𝐚𝐫𝐦𝐚𝐜𝐨𝐩𝐨𝐞𝐒𝐚 𝐰𝐑𝐒𝐜𝐑 𝐒𝐬 π₯𝐒𝐀𝐞π₯𝐲 𝐭𝐨 π›πž 𝐞𝐟𝐟𝐞𝐜𝐭𝐒𝐯𝐞 𝐟𝐫𝐨𝐦 πƒπžπœπžπ¦π›πžπ« 1, 2022.

It will impact public health in the long term in a big way. Of the 92 new monographs, there are 60 chemicals, 21 vitamins, minerals, amino acids, fatty acids, etc., 3 biotechnology-derived therapeutic products, 4 human vaccines, 2 blood and blood related products, 2 herbs and herbal related products, and 7 phytopharmaceutical ingredient category monographs.

Besides this, IP 2022 also contains 652 pharma reference substances covering 70 per cent requirement of reference materials used for quality control in the country. Currently, there are 300 impurity standards in IP which are crucial for managing pharmaceutical quality. So, there are a total number of 3152 monographs in the current edition of IP. Several monographs and general chapters have also been revised to update them as per current global requirements and to harmonize with other pharmacopoeias like USP, BP, EP, etc.

The harmonization of standards with global standards is expected to help IP getting recognized and accepted in foreign countries.

The ministry deserves kudos for releasing the latest version of the pharmacopoeia as it is important to maintain standard quality of medical products - vaccines, medicines, equipment, etc. and to keep an eye on the effect of these medicines on patients.

βœ”οΈDefinitely, the 9th edition of IP will be a step forward to deliver quality medicines to the public at large.

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