Patient safety and well-being lie at the heart of all our pharmacovigilance operations at ProRelix Research. We are with you every step of the way-from development of a pharmacovigilance system to regular reporting of safety and adverse events to regulatory authorities. Our team of medical professionals and data experts has knowledge of the specific requirements for pharmacovigilance practices in India and can help you stay compliant and up to date with regulations.
Pharmacovigilance and drug safety monitoring is important in a vast and populous country like India where the rates of adverse drug reaction (ADR) vary geographically with prescribing patterns, and where research and development efforts are focused on developing new drugs. Since all safety concerns and ADRs cannot be captured during the limited time frame and under stringent protocols of a clinical trial, safety monitoring post-marketing or post-authorization is vital. Pharmacovigilance involves the concerted effort and communication between various entities such as health care professionals, pharmacists, physicians, regulatory agencies, and industry to allow for relay of information and reporting of ADRs that can further inform medical decision-making and integration into practice.
In India, the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority that is responsible for the approval of drugs, medical devices, and cosmetics, conduct of clinical trials, development of standards for drugs, and control over imported drugs. CDSCO’s primary role is to protect public health and conducts the Pharmacovigilance Program of India (PvPI). Pharmacovigilance activities under PvPI are carried out by the National Coordination Center (NCC) at Indian Pharmacopoeia Commission (IPC).
Two guidance documents on pharmacovigilance requirements have been prepared and published by IPC in collaboration with the CDSCO. The ‘Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products’ includes various modules that help delineate risks associated with pharmaceutical products and establish pharmacovigilance systems at the marketing authorization holder (MAH) organization to mitigate the risks. This document is applicable for new and approved drugs, biologics, radiopharmaceuticals, and phytopharmaceuticals. This guidance document contains various modules that include detailed information on the following:
Maintenance, content, and submission of Pharmacovigilance System Master File (PSMF)
Collection, processing, and reporting of Individual Case Safety Reports (ICSR)
Preparation and submission of Periodic Safety Update Report (PSUR)
Establishment and Maintenance of Quality Management System (QMS) for pharmacovigilance activities
Planning, conduct, reporting, and follow-up of pharmacovigilance inspections by regulatory authorities
Development and submission of a Risk Management Plan (RMP)
The emergence of India as a hub for the manufacture and supply of vaccines has led to the development of a guidance document that specifically addresses pharmacovigilance requirements for biological products namely vaccines. This document describes the roles and responsibilities of various regulatory authorities in relation to pharmacovigilance activities such as data collation and reporting of adverse event following immunization (AEFI). It also provides information for the MAH on pharmacovigilance methods and documents such as ICSRs, PSURs, and Phase IV post-marketing studies.
To ensure long-term safety of patients and assess risk/benefit balance, we provide the following services specific for the Indian regulatory environment as per Schedule Y of the Drugs and Cosmetics Act, 1940
- Development of PSMF
- Standard Operating Procedure (SOPs) creation for pharmacovigilance activities: training documents, ICSR reporting, PSUR preparation, safety data archival and retrieval, audit and quality control activities, signal detection and evaluation processes
- Collation of safety data from spontaneous reports, published research, digital media, patient support programs, reports from regulatory authorities
- Training programs for staff on practices for data collection such as adverse event reporting
- Literature reviews using electronic databases (PubMed, Embase) for safety information
- Validation of ICSRs prior to submission to PvPI
- Medical coding of adverse events using MedDRA
- Aggregate report writing and submission (PSURs) as per the recommended schedule
- Preparation for ‘mock’ audits and recommended corrective and preventive action (CAPA)
- Risk management plan (RMP) writing and updating
- Design of Phase IV post-marketing studies
- Signal detection and evaluation services
- Monitoring and reporting of adverse events using VigiBase database
- Liaising with KOLs to minimize product risks
- Development of risk management action plans: patient and healthcare practitioner educational material and training programs, liaising with KOLs to minimize product risks
- Submission of adverse event following immunization (AEFI) case report forms
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