IPC finalising 6th edition of Indian pharmacopoeia with 300 new monographs
The Indian Pharmacopoeia Commission (IPC) is giving final touches to the sixth edition of the Indian pharmacopoeia which will incorporate around 300 new monographs on different therapeutic groups representing anti-malarial, anti-tuberculosis, anti-retroviral and biological drugs.
Sources in the IPC said that the Commission is busy finalising the sixth edition of the Indian pharmacopoeia and the date of release and its implementation will be announced later. Apart from the around 300 new monographs, the commission is upgrading more than 350 existing monographs of Indian pharmacopoeia-2007 on the lines of US pharmacopoeia and other pharmacopoeia of the developed countries, keeping in mind the International Conference of Harmonisation (ICH) guidelines.
In the new edition, the commission will come out with new monographs on the drugs of the lifestyle diseases such as hypertension, diabetes, etc which are of great concern to the society due to the rapid increase of these diseases in the country.
Besides, special emphasis will be given to drugs of medicinal plants and their extracts and drugs of biological origins. The commission will upgrade the vaccine monographs of recombinant biotechnological products. There will be a general chapter on biotechnological products for proper understanding of the standards by the stakeholders.
Apart from these drugs, veterinary drugs will also get special attention in the sixth edition of the Indian pharmacopoeia as the commission will upgrade more monographs in this category, sources said.
The fifth edition of Indian pharmacopoeia, in three volumes including over 1600 monographs, was published in December 2007 and was made effective from July 1, 2008.
Regular updating of the Indian Pharmacopoeia is necessary for bringing out an overall improvement in quality of drugs in the country. The Indian pharmacopoeia will facilitate the manufacturers and other stakeholders to ensure compliance with the technological advancements taken place in the related fields. As India has emerged as one of the payers in generic drugs and also poised for phenomenal growth of pharmaceutical industry, both in terms of volume and value of production, there is an urgent need to frequently upgrade the new monographs by incorporating the changes in the existing analytical procedures.