India needs to make it mandatory for pharmaceutical companies to have pharmacovigilance (PV) audit to ensure patient safety and good pharmacovigilance practices (GPvP), stated Moin Don, a leading pharmacovigilance expert and chief executive officer & founder of PVCON Consulting Services.

PV audit is a critical review and analysis of the compliance with global and local regulation, internal Standard Operating Procedures (SOPs), contracts/agreements of the systems supporting the monitoring of adverse events and signal detection. The aim of the audit is to provide assurance that the internal PV and related systems are robust to protect patient safety. PV audit has become legal requirement in European Union, USA and other regulated markets. Pharma companies exporting products to these markets are required to conduct audit of pharmacovigilance system regularly, said Don, who is closely associated with government of India’s National Pharmacovigilance Programme as Advisor and Trainer for DCGI & PVPI staff and has also been a trainer for Uppasala Monitoring Centre’s PV Workshop in Asia Pacific region.

As of now India does not have such requirements. However Indian drug regulatory agency CDSCO, Indian Pharmacopoeia Commission (IPC), national coordinating centre of Pharmacovigilance Programme of India (PvPI) have drafted good pharmacovigilance practice guidelines mandating PV inspection of stakeholders especially market authorisation holders, responsible for marketing drugs in India by drug regulatory agency. The good pharmacovigilance practice guidelines are yet to be implemented, he said.

In the absence of binding requirements, it's very difficult to ensure industry compliance with good pharmacovigilance practices, he opined.

IPC has been doing a remarkable work in strengthening the PvPI programme ever since its commitment as NCC. In the last six years we have witnessed significant development and awareness of the same through a thorough work approach. There is still lots to do, Don stated.

Currently PV audits are conducted by big pharma companies. They have quality and assurance department conducting internal PV audit. Other pharma companies lacking quality and assurance function, generally outsource PV audit to consultants who are PV auditors.

Once the GPvP guidelines are implemented, there would be a big leap forward in implementing and practising pharmacovigilance activities in India.

Indian drug regulator has stepped up efforts to strengthen pharmacovigilance practices in the country.

In March 2016, a notification was issued to pharmaceutical industry by DCGI, asking them to put in place pharmacovigilance system and have a qualified person who would be responsible for management of pharmacovigilance in the company. With this, pharma companies are now required to start pharmacovigilance activity and this will in turn improve adverse drug reporting (ADR) to PvPI.

When asked small and mid size companies facing challenges in implementing PV activities, he said “Small companies can start with PV activity with 2-3 persons without a database. It's essential to have SOPs and to train your people in SOPs especially marketing support. The companies can then start getting ADRs from doctors, prescribers, medical representatives. Gradually companies can develop robust pharmacovigilance system.”

In a bid to educate pharmaceutical professionals about basics and regulatory aspects of pharmacovigilance, training programmes are conducted by IPC, said Don, who has helped IPC finalise two-week long pharmacovigilance training programme for stakeholders including pharma industry professionals, healthcare providers, etc.