DDReg Pharma

Pharmacovigilance Services in India

A need for robust pharmacovigilance system is a must for protecting patient safety and adverse drug reaction reporting still remains one of the public health issues. Pharmacovigilance program for India (PvPI) with National Coordination Centre-Indian Pharmacopoeia Commission, Ghaziabad under the leadership of the Central Drugs Standard Control Organisation (CDSCO) oversees the benefit-risk profile of medicines and adverse drug reaction (ADR) reporting in India. Under this program, ADR data is collected from the ADR monitoring centres (AMC) across India from voluntary reports received from healthcare professionals, other HCPs, consumers, and Marketing Authorization holders (MAH) and reported to NCC-PvPI in the form of individual case safety reports reported through IPC as well as CDSCO websites. This data is then analysed and used to detect new signals or provide safety data on the existing drug. Like any other country, Indian PvPI also faces challenges with the under-reporting of the adverse event data.

As a leading global contender, DDReg understand the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in India that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices’

DDReg pharmacovigilance Services portfolio include:
ICSR Processing and Submission
Risk Management Plan
Aggregate Reports
Signal Management
QPPV Services
PV Audit & Compliance
Send us a Message