The manuscript of the fifth edition of Indian Pharmacopoeia, with 300 additional monographs, is ready and is slated for release in December to be made effective from April 2008, thanks to the massive work put jointly by the Indian Pharmacopoeia Commission and other experts.
The Indian Pharmacopoeia 2007, coming out in three volumes, will have 175 new monographs of chemicals and dosages forms. It will also have monographs on vaccines, immunosera, herbs, herbal products, blood and blood-related products, biotechnology and veterinary products.
"It was made possible only because of the hard work of the scientists with the Commission, the scientific body members, experts from across the country and abroad including those from the private sector. We have been working day and night for four months to make it possible. The editing works are over and is being sent to the Press now," IPC secretary-cum-scientific director Dr G N Singh said while thanking all those from the industry and academicians who contributed in the effort.
He said the coming edition will have lots of new features in user-friendly format. The scope of the same had been extended to include biotechnology, indigenous herbs, herbal products, viral vaccines and additional antiretroviral drugs and formulations inclusive of commonly used fixed-dose combinations.
"The edition will be presented in a new style so that there is greater uniformity in editorial presentation. According to the policy of the commission now, monographs and pharmaceutical preparations are not elaborated, with exception of those on immunosera for human use, immunasera for veterinary use, some biological preparations, vaccines for human and veterinary use," he said.
But the new edition is presented in a user-friendly format using the latest advances in technological and experimental methods widely adopted in India and abroad. "Contents of appendixes are divided into by and large in consonance with those now adopted internationally for monitoring quality of drugs," he explained.
The director said the scientists have been working without a break over the last few months and at least 100 experts from abroad extended assistance. Scientists from companies like Ranbaxy and experts from institutions like DIPSAR and AIIMS also were among those who contributed to the massive effort of updating the standardization document of Indian drugs sector.
The new edition would supersede the 1996 edition but the exiting monographs were not disturbed and not included in the present edition as they would continue as official. Cross-referencing would be avoided to make each monograph complete in itself for convenience.
The director said the names of new monographs appearing in the new edition and other details were also being included in the official website
(www.ipc.gov.in) for the reference of the pharmaceutical industry and others.
The IPC had published IP Addendum 2005 to IP 1996 with amendments in existing monographs and adding 46 new monographs and it was made effective from June 30, 2006. The 1996 edition had 1250 monographs. Ever since, the IPC secretariat has been on the huge task of bringing out the new edition in a comprehensive and more user-friendly format.