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Challenges in Developing IP Monographs: Ensuring Quality and Compliance in Indian Pharmacopoeia

This article discusses the current issues and challenges faced in the development of IP monographs by the Indian Pharmacopoeia Commission. It emphasizes the importance of compliance with IP standards for ensuring the quality of drugs and pharmaceuticals. The article also highlights the need for sustainable compliance and the upcoming amendments in the IP 2009 edition. Collaboration and harmonization efforts in the field of pharmacopoeial standards are also discussed.

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Challenges in Developing IP Monographs: Ensuring Quality and Compliance in Indian Pharmacopoeia

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  1. Current issues and challenges in the development of IP monographs Dr. G.N. SinghSecretary-cum-Scientific DirectorIndian Pharmacopoeia CommissionGhaziabad.

  2. Indian Pharmacopoeia is the official book of standards for drugs included therein, in terms of the Second Schedule to the Drugs and Cosmetics Act, 1940so as to specify the: Standards of identity, purity and strength for the drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India.

  3. It is a reference document for various stockholders like enforcement agency, industry, lab, academic institutions etc.Compliance with IP Standards by drug manufacturing industry assures consumers, patients and healthcare professionals of their quality.

  4. As India is the best developer of generic pharmaceuticals and taking the lead in adopting new technologiesTherefore there is a need for the sustainable compliance of quality specifications of drugs and pharmaceuticals. IP ensures the control of the quality of not only the formulations (dosage forms) but also of the active pharmaceutical ingredients (APIs).

  5. Current Issues Amendments to IP 2007 have been published in IP Addendum 2008. Further amendments are to be taken care of in IP 2009 edition. Publication of IP 2009 by Dec. 2009 is the immediate priority. Work is in full swing.

  6. 159 Drug molecules have been short listed for the IP 2009. The APIs and their formulations monographs are being prepared at the IPC. Monograph inclusion/deletion criteria and the Monograph Inclusion Form have been uploaded on thewebsite of the Commission.

  7. Indian National Formulary 1st Edition 1960 2nd Edition 1966 3rd Edition 1979 It is a reliable reference book on drugs formulations for the practicing physicians/ clinicians, pharmacists, clinical pharmacists, nurses and others engaged in healthcare profession.

  8. The draft of the INF is ready for the comments • It will enable the public to obtain treatment at reasonable cost. • It will form an integral part of rational therapeutics as far as teaching institutions are concerned.

  9. 1. Arrangement, procurement, preparation, evaluation, containerization and distribution of all the IP Reference Substances is still a challenge for the Commission. 2. The Commission has identified the Chemical Reference Substances and impurities RS required on the priority basis and 115 Reference Substances certified by the Commission. The issue of the remaining ones is to be addressed shortly. . 3. Collaborative testing with NABL accredited laboratories, before certification is imperative. Challenges

  10. IPC has the strategy to start pharmacopoeial Education and Training Programme for generating talented human resource. Harmonization: Collaborative efforts needed to bring harmonization/uniformity of Standards. It will reduce wastage of resources and time. Training and Harmonization

  11. IPC already has tied up with USP. British Pharmacopoeia Commission and EDQM are also keen to have working relations with IPC.

  12. -Harmonization of general procedures/practices -Harmonization of monographs -Understanding each other -Avoidance of duplicative testing -Break the barriers of trade across the world Collaboration will lead to-

  13. THANKS

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