The recently released IP 2010, which was originally scheduled to come into force from September 1, 2010, will now be implemented from December 1, 2010, according to the Scientific Body of the Indian Pharmacopoeia Commission (IPC) which met at Ghaziabad on August 20. This was done to accede to the request of IDMA and other professionals to give some time for study and implement the new standards.
“We will provide all support to the functioning and upgrading of IPC so that it can fulfil all the needs of the ensuring quality of medicines produced, sold and exported from India. India pharmacopoeia laboratory has also updating and creating a modern containerization facility to prepare and pack reference substances that are required while testing drugs. A few reference standards are already available for supply to the industry and all efforts are made to enhance this service in the next few months. IPC has its office and laboratory located at Ghaziabad in UP” said Dr G N Singh, Secretary cum Scientific Director of IPC.
“Very few monographs on herbals and vaccines were seen in USP and BP prior to 2007 when Indian Pharmacopoeia introduced them for raw herbs and products. IP has been slowly developing the monographs on herbals and today has 89 monographs. USP and BP have officially signed MoU’s with IPC and Government of India to use the data in IP with a view to introduce herbal monographs in their pharmacopoeial books, giving recognition to Indian herbals which have long history of safe usage. BP is planning to introduce 15 monographs on Indian herbs. IP 2010 has enlarged the monographs on herbal extracts which are more popular in commerce for they come with standardization and are easy to use for making supplements or for use in cosmetics. Quality specifications for 47 raw herbs, 20 herbal extracts, 16 processed herbs and excipients and 6 finished products, have been developed and added in IP 2010”, said Dr DBA Narayana, chairman of Herbal Products Committee of the IPC’s Scientific Body.
The 2068 monographs have been included in this edition comprising of 1832 monographs on active pharmaceuticals and products, 89 herbal monographs, 89 veterinary medicines standards and 58 monographs on vaccines and immunosera. A total of 259 monographs have been added on pharmaceuticals for the first time in this edition and 22 new monographs on Herbal extracts and products have been also added apart from 8 for veterinary medicines and 17 for vaccines and sera.
IP also has expanded the standards for 21 excipients (inert aids) used for making formulations. IPC has been constantly looking to expand the coverage of standards for recently introduced drugs, vaccines, herbal products which are either present in essential medicines lists or found essential for common man.
“With the growing interest in herbals globally, IPC has been working for the last 3 years to provide scientifically developed and objectively assessable quality standards for raw herbs, herbal extracts and products available in commerce. All manufacturers in India have to meet the minimum quality standards prescribed in IP”, said Dr Singh.
“It was IP which introduced quality standards for anti- retroviral drug actives and its finished drugs. The 2010 edition of IP has added standards for 12 more anti AID drugs to its earlier edition. USP and BP followed IP by introducing such monographs in their books”, said Dr Nitya Anand, chairman of the scientific body of IPC.