Eighth Edition of Indian Pharmacopoeia (IP-2018) released by Secretary, Ministry of Health & Family Welfare, Government of India on 29th Sept. 2017. On this occasion the Catalog of IP Reference Standard and Pharmacovigilance Guidance Document including Mobile App are also launched.
1. “ADR PvPI” Android Mobile App [developed in-house] for ADR reporting:
NCC-PvPI has developed an advanced version of the android mobile app which empowers all the healthcare professionals and consumers for Adverse Drugs Reaction (ADR) reporting. This new app has been developed to have administrative control of data with IPC, NCC-PvPI with the following features:
· Supports source document and image attachment
· Supports HCPs as well as consumer reporting
· XML generation
· Auto filling of report details to save time
2. Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products:
In order to ensure smooth functioning of Pharmacovigilance activities by Pharmaceutical industries, NCC-PvPI, IPC in collaboration with Central Drugs Standard Control Organization (CDSCO) developed Pharmacovigilance Guidance for Marketing Authorization Holders of Pharmaceutical Products
This Pharmacovigilance guidance document is introduced for the first time by the Government of India for Pharmaceutical industries which aim to establish and ensure an effective Pharmacovigilance system at their site as per recent amendment in Drugs & Cosmetics Rules, 1945, Schedule Y vide Gazette Notification G.S.R. 32 (E) published on 08 Mar 2016.
The MAHs Pv Guidance Document comprises of following modules:
MODULE 1 – Pharmacovigilance System Master File
MODULE 2 – Collection, Processing & Reporting of Individual Case Safety Reports
MODULE 3 – Preparation & Submission of Periodic Safety Update Report
MODULE 4 – Quality Management System at Marketing Authorization Holder Organization
MODULE 5 – Audits & Inspections of Pharmacovigilance System at at Marketing Authorization Holder Organization
MODULE 6 – Submission of Risk Management Plan
Indian Pharmacopoeia Commission (IPC) 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. It’s 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.
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.
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. The work of the IPC is performed in collaboration with members of the Scientific Body, subject experts as well as with representatives from Central Drugs Standard Control Organization (CDSCO), State Regulatory authorities, specialist from Industries, Associations, Councils and from other Scientific and Academic Institutions.
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.
As per the policy of IPC, IP monographs are not framed to detect all possible impurities. The prescribed tests are designed to determine impurities on which attention are required to be focused, to fix the limits of those that are tolerable to a certain extent, and to indicate methods for ensuring the absence of those, that are undesirable. It is, therefore, not to be presumed that the impurities can be tolerated because they have not been precluded by the prescribed tests.
Distinction exists between Pharmacopoeial Standards and Manufacturer’s release specifications. Pharmacopoeial standards are publicly-available compliance document that provide the means for an independent check about the quality of a product, all time during its shelf-life. To ensure compliance related to pharmacopoeial requirements, the manufacturer’s specifications may need to be more exacting than corresponding pharmacopoeial specifications.