Indian Pharmacopoeia Commission releases Pharmacopoeia 2010 edition

The Indian Pharmacopoeia Commission (IPC) has released the sixth edition of the Indian Pharmacopoeia (IP 2010). It is presented in three volumes and the scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations.

The IP 2010 incorporates 1918 monographs of drugs out of which 287 are new monographs consisting of APIs, excipients, dosage forms and herbal products etc. It is hoped that this edition would play a significant role in improving the quality of medicines which in turn promote public health and accelerate the growth and development of pharma sector.

Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations not in use now a days are omitted from this edition. It is published in fulfilment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder.

It prescribes the standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines. The standards of this pharmacopoeia are authoritative and legally enforceable. It intends to help in the licensing of manufacturing, inspection and distribution of medicines.

IP is published in continuing pursuit of the mission of IPC to improve the health of the people through ensuring the quality, safety and efficacy of medicines. The Commission has been receiving significant inputs from regulatory, industrial houses, academic institutions, national laboratories, individual scientists and others. Publication of IP at regular and shorter intervals is one of the main mandates of the Commission.

An IPC release said that the sixth edition of Indian Pharmacopoeia is published in accordance with the principles and designed plan decided by the Scientific Body of the IPC. To establish transparency in setting standards for this edition the contents of new monographs, revised appendices and other informations have been publicized on the website of the IPC, besides following conventional approach of obtaining comments. The feedback and inputs were reviewed by the relevant Expert Committee to ensure the feasibility and practicability of the standards and methods revised. The principle of "openness, justice and fairness" is kept in mind during compiling and editing the contents of this edition.

posted on : 10 Aug '10