The new edition of Indian Pharmacopoeia (IP) 2006 will come out by the end of this year or the beginning of the next year and will have latest reference standards for about 50 new drugs, said Dr. G.N. Singh, secretary cum scientific director, IP Commission.
Addressing the 9th Indian Drugs Manufacturers Association (IDMA)-APA Pharmaceutical Analysts Convention 2006 in Mumbai, Dr. Singh said another 250 reference standards would be created within another five years, added every year. The Indian Pharmacopoeia (IP) Addendum 2005 has been published and it contains 46 new monographs including three for bulk drugs (adenine, fructose and lopinavir), 22 for large volume parenterals, ten for antiretroviral formulations, ten for medicinal plants (herbal drugs) and one for Oxygen 93 per cent.
IP Commission, which took off recently, has given preference to collaborating with various pharmacopoeias like European pharmacopoeia, USP, ChP, JP, IP etc. to evolve common reference standards. At present though both Indian pharmacopoeia and European pharmacopoeia have about 100 odd monographs each, only 50 per cent of the standards are common for both the pharmacopoeias. Effort would be to harmonise and incorporate the best features of the various pharmacopoeias and enter into collaboration for developing common standards, said Dr. G.N. Singh.
Dr. Agnes Artiges, director, European Directorate for the Quality of Medicines (EDQM) said that at present the Council of Europe (CoE) had 46 nations as members and EDQM took necessary measures to ensure that the monographs developed by EP will become the common official standards for the EU nations. At present European pharmacopoeia standards were mandatory at the same date of publication in 34 CoE states. EDQM's activities included publication of the EP, producing and distributing pharmaceutical, biological RS standards, CoS of Ph.Eur monographs, participating in the European regulatory system by a centralised evaluation of the quality of drug substances and excipients, European biological standardisation programme, European Network of the Official Medicines Control laboratories (OMCL) etc.
Dr. Claude Coune, head of the publication and IT division, EDQM elaborated the monograph development process for the European pharmacopoeia and ways to participate in the work programme of the EP.
Ajith Singh, Chairman, ACG Worldwide inaugurated the event and the keynote address was delivered by Suresh G Kare, president, IDMA. More than 200 delegates are participating in the two-day convention, which began at ITC Grand Sheraton hotel in Mumbai on January 23.