Indian Pharmacopoeia Commission (IPC) is planning to include the monographs of all drugs that come under the National List of Essential Medicines (NLEM) in the forthcoming edition of Indian Pharmacopoeia (IP). The IPC will also see that all new drugs approved by the Drugs Controller General of India (DCGI) during the last 10 years are included in the new edition.
According to IPC sources, an expert committee headed by Dr Y K Gupta of All India Institute of Medical Sciences (AIIMS) is working on the list of drugs that need to be included in the new edition. The committee may submit a list of 80-100 drugs that are to be part of the IP. The committee is of the opinion that all drugs having relevance to the country should find place in IP.
As pharmabiz had reported earlier, IP had given in principle nod to incorporate the monographs of about 20 new generation drugs used for the treatment of life style diseases recently. This was in response to the plea made by Indian Drugs Manufacturers Association (IDMA) to include them in the next edition of IP. While IDMA had submitted the monographs along with validation protocols for these drugs, the IPC is to validate the protocols in government drug standard setting laboratories before proposing them to be part of IP.
The revised edition of IP (Edition 2006) will contain the monographs that have appeared in all three addendums published during the period. Appropriate changes will be made wherever necessary. Edition 2006 will take care of upgradation of latest techniques for standardization of drugs.
"Modern instrumentation techniques will be incorporated to ensure the acceptability of IP with any other official compendium. There are about 50 monographs that will be added in the revised IP. This includes 11 Anti-retrovirals, 24 LVPs, ORS etc and herbal drugs. Veterinary standards, which will help others, accept our standards are also being prepared. IP 2006 will have its uniqueness," IPC sources informed.
The new edition, to be ready by mid 2006 for expert scrutiny and approval, may get published by the year-end, sources added.