Indian Pharmacopoeia Commission (IPC)

Subject: Polity

Section: National Body

Context: The Union Ministry forHealth& Family Welfare published a new Bill to replace the colonialera Drugs & Cosmetics Act, 1940.

Concept:

It is an Autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India.
IPC is created to set standards of drugs in the country.

Functions

Its basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region.
It publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP).
It further promotes rational use of generic medicines by publishing National Formulary of India.
IP prescribes standards for identity, purity and strength of drugs essentially required from health care perspective of human beings and animals.
IPC also provides IP Reference Substances (IPRS) which act as a finger print for identification of an article under test and its purity as prescribed in IP.

Indian Pharmacopoeia (IP)

It is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health & Family Welfare, Government of India in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules 1945 there under.
IP is recognized as the official book of standards for the drugs being manufactured and/or marketed in India.
IP contains a collection of authoritative procedures of analysis and specifications of drugs for their identity, purity and strength.
The standards of the IP are authoritative in nature and are enforced by the regulatory authorities for ensuring the quality of drugs in India.
During quality assurance and at the time of dispute in the court of law the IP standards are legally acceptable.
The Standards prescribed in the IP are to establish the compliance with regulatory requirements on an article.
The criteria to be adhered are: The interpretation of a monograph must be in accordance with all the general requirements, testing methods, texts and notices pertaining to it, in the IP.
A product is not of standard quality unless it complies with all the requirements of the monograph.

The National Formulary of India

It is essentially meant for the guidance of the members of the medical profession; medical students, nurses and pharmacists working in hospitals and in sales establishments.
In the preparation of this Formulary, the expert opinion of medical practitioners, teachers in medicine, nurses, pharmacists and Pharmaceutical manufacturers has been obtained.
The selection of drugs for inclusion in the National Formulary has been made taking into consideration the relative advantages and disadvantages of the various drugs used, the extent of their use in current medical practice and their availability in the country.
Thus the National Formulary of India represents a broad consensus of medical opinion in respect of drugs and their formulations and provides the physician with carefully selected therapeutic agents of proved effectiveness which form the basis of national drug therapy.

The Pharmacovigilance Programme of India (PvPI)

It was launched with a broad objective to safe guard the health of 1.27 billion people of India.
Adverse drug Reactions (ADRs) are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base.
NCC-PvPI monitors the ADRs among Indian population and helps the regulatory authority of India (CDSCO) in taking decision for safe use of medicines.

Quality Assurance (QA)

The Indian Pharmacopoeia Commission (IPC) is maintaining quality management system through its Quality Assurance Department (QA).
The Quality Assurance Department is playing a vital role in the maintenance of quality standards.
The purpose of the quality assurance department is to maintain the quality system of the Indian Pharmacopoeia Laboratory at Indian Pharmacopoeia Commission and ensure its compliance with “General Requirement for the Competence of Testing and Calibration Laboratories” (ISO/IEC17025:2017), “General requirement for the Competence of Reference Material Producer” (ISO/IEC 17034:2016), “Conformity Assessment- General requirement for Proficiency Testing” (ISO/IEC 17043:2010) and WHO prequalification, adherence to the laid down system and procedures at IPC.