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IPC turns down CDSCO’s appeal for extension of timeline to implement IP 2022
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Laxmi Yadav, Mumbai
November 23 , 2022
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The Indian Pharmacopoeia Commission (IPC) has rejected Central Drugs Standard Control Organisation (CDSCO)’s request for extension of timelines to implement Indian Pharmacopoeia (IP) 2022.
Drugs Controller General of India (DCGI) Dr VG Somani on October 28, 2022 wrote to Dr Rajeev Singh Raghuvanshi, secretary-cum-scientific director, IPC urging him to extend the deadline for implementation of ninth edition of IP 2022 which will be effective from December 1, 2022.
Dr Raghuvanshi on October 31, 2022 in a letter to Dr Somani turned down the CDSCO’s appeal, stating that this year IPC has already given sufficient time for the implementation of new standards included in IP 2022 which is in line with global practices followed by other pharmacopoeias.
Copies of IP 2022 were available for purchase from IPC after its release on July 1, 2022 by Union minister of health and family welfare Dr Mansukh Mandaviya. IP 2022 contains new additions and revisions which were already available on IPC website for a long period for public comments before their publication in the IP 2022, he stated.
“IPC has introduced a new general chapter on 'Elemental Impurities' which is not referred to in the individual monographs, and therefore, remains a non-mandatory requirement. However, stakeholders may adopt and implement this general chapter as an alternative to test on heavy metals as per the provisions of the IP general notices. It is proposed that 'Elemental Impurities' will become mandatory from the next IP edition. Similarly, a new general chapter on `Nitrosamine Impurities has been introduced in IP 2022 for guidance of the stakeholders. This chapter is referred to in sartan API monographs of the IP and it is expected that stakeholders adopt this general chapter for determining the nitrosamine impurities in other drugs as well, wherever deemed appropriate and necessary,” added Secretary-cum-Scientific Director, IPC.
Currently, there are 660 IP Reference Substances and 365 Impurity Standards available from IPC. This list is continuously increasing and being updated in real time. In addition, IP has already given a provision in Chapter 5.4 Reference Substances to allow use of other pharmacopoeial standards if IP Reference Standard is not available, he opined.
“In view of the above, I regret to inform you that request for extension for the implementation of IP 2022 is not acceptable,” stated Dr Raghuvanshi in a letter to DCGI.
IP 2022 contains a total of 92 new monographs, including 60 chemical, 21 vitamins, minerals, amino acids, fatty acids, etc., three biotechnology-derived therapeutic products, four human vaccines, two blood and blood-related products, two herbs and herbal-related products, and seven phytopharmaceutical ingredient category monographs. This has led to the total number of 3,152 monographs in the current edition of IP. In addition, 12 new general chapters have also been introduced. Several monographs and general chapters have also been revised to update them as per current global requirements and to harmonise with other pharmacopoeias like USP, BP, EP, etc. The harmonisation of standards with global standards is expected to help IP getting recognised and accepted in foreign countries.
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