The Indian Pharmacopoeia Commission is ready with the draft of IP Addendum 2008, incorporating suitable suggestions made by the stakeholders to the Indian Pharmacopoeia 2007, and will release the same by the end of December.

The Addendum will have 63 new monographs in different therapeutic areas. It will also carry amendments to the latest edition of IP as desired by the stakeholders in the general chapters, appendixes, monographs, impurities and other quality related issues, IPC sources said.

The subject experts and the scientific body of the Commission have already vetted the amendments to be included in the addendum. The new monographs will include those from veterinary, herbal and vaccine areas. The fifth edition of Pharmacopoeia, in three volumes including over 1600 monographs, was published in December last and was made effective from July 1.

For the first time, the IPC is also taking steps for validation and certification of 90 reference substances. The process has already started and reference standards are expected to be ready by the end of December itself. It has also started collaborating with a number of CSIR institutions including CDRI and the industry for preparing the reference substances. The next edition of the pharmacopoeia will have reference substances of herbs and herbal products also for the first time. While CDRI will help prepare the standards for the chemical products, the Central Institute of Medicinal and Aromatic Plants (CIMAP) will pitch in with inputs in the herbal area, sources said.

Meanwhile, the standard setting organization has started holding a series of training sessions for the industry and other stakeholders in different parts of the country. It is also holding a symposium in connection with the forthcoming Indian Pharmaceutical Congress, slated from December 12-14 in Delhi. Experts from different bodies like US Pharmacopoeia, British Pharmacopoeia, EDQM and the industry would lead the seminar, which will be beneficial for the stakeholders.

Besides briefing the participants drawn across the country on the existing standard parameters, the symposium will also take feedback from the industry and others to improve the working of the Pharmacopoeia Commission and its editions of pharmacopoeia.