The forthcoming Addendum to Indian Pharmacopoeia (IP) is to include monographs of herb based drug products for the first time. The Addendum 2003, which is currently in the compilation process, has identified eight herbal monographs. These monographs currently undergoing reviews and revalidations by the industry participants in the IP Committee, are on the herbs Adhatoda vasica, Andrographis paniculata, Glycyrrhiza globra, Commiphora wightii, Centella asiatica, Picrorhiza kurroa, Withania somnifera, Zinziber officinale and Boswellia serrata.

This is the first time the herbal product monographs are being developed in the IP format to be introduced in the modern drug standards directory in the country. The Addendum will be launched by December 2003, said Dr Nitya Anand, chairman, Indian Pharmacopoeia Committee.

The new Addendum of IP will also include monographs on 10 more antiretroviral (anti- AIDS) drugs manufactured in India. The last Addendum, which came out in 2002 had introduced monographs on 12 antiretroviral APIs and their 21 formulations manufactured in India.

The anti-AIDS drugs introduced in the IP 2002 Addendum includes Didanosine, Efravirenz, Lamivudine, Nevirapine, Stavudine, Zidovudine, Abacavir, Indinavir, Nelfinavir, Ritonavir and Sasquinavir. IP was the first Pharmacopoeia in the world to introduce monographs on antiretroviral drugs. With the new Addendum, there will be a total of 22 antirtroviral monographs in the IP.

Dr Nitya Anand also informed that the IP has also made revisions of the monographs of newer vaccines like Hepatitis B and Rabies using rDNA technology recently. "As the Indian Pharmacopoeia is now receiving greater global recognition, it has become more important to maintain the quality. As part of this, it has made revisions in general monograph on HPLC and specifications for plastic containers for LVPs. The IP has also extended the test for bacterial endotoxins to the other parenterals recently," he said.