Saturday, August 24, 2013

Sixth edition of the Indian Pharmacopoeia is out

Sixth edition of the Indian Pharmacopoeia is out
The sixth edition of the Indian Pharmacopoeia (IP 2010) is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Government of India, Ministry of Health & Family Welfare. The Indian Pharmacopoeia (IP) 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.

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.

The Indian Pharmacopoeia 2010 is presented in three volumes. 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. 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.

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.


About Indian Pharmacopoeia (IP):
Indian Pharmacopoeia (IP) is an official document meant for overall Quality Control and Assurance of Pharmaceutical products marketed in India by way of contributing on their safety, efficacy and affordability. IP contains a collection of authoritative procedures of analysis and specifications for Drugs. The IP, or any part of it, has got legal status under the Second Schedule of the Drugs & Cosmetics Act, 1940 and Rules 1945 there under.      

IP prescribes standards for identity, purity and strength of drugs essentially required from health care perspective of human beings and animals. IP standards are authoritative in nature. They are enforced by the Regulatory authorities for quality control of medicines in India. During Quality Assurance and at the time of dispute in the court of law the IP standards are legally acceptable