Date: Saturday, July 15, 2023

In a recent session at the 9th International Pharmaceutical Exhibition (iPHEX) held in Hyderabad, experts highlighted the significance of leveraging digital technologies for adverse drug reactions (ADRs) Reporting. This approach not only helps evaluate our ability to detect signals of adverse events but also enables effective regulatory decision-making in a timely manner to ensure patient safety. The event, organized by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with support from the Union commerce ministry, provided a platform to discuss these crucial aspects. Dr. Viranchi Shah, the national president of the Indian Drug Manufacturers’ Association (IDMA), moderated the session.

The Indian Pharmacopoeia Commission (IPC), based in Ghaziabad, had introduced a physical format for voluntary reporting of suspected ADRs by healthcare professionals three years ago as part of the Pharmacovigilance Programme of India (PvPI). As the National Coordination Centre (NCC) for PvPI, the IPC also launched a medicine side effect reporting form to facilitate ADR reporting by consumers and patients. Additionally, a Toll-Free PvPI Helpline, 1800-180-3024, was made available for the public on weekdays from 9:00 am to 5:30 pm.

According to Dr. Ranga Reddy Burri, president of the Infection Control Academy of India (IFCAI), around 80% of Micro, Small, and Medium Enterprises (MSMEs) are currently not covered by PvPI. Dr. Burri emphasized the need for universal applicability of ADR reporting and stricter PvPI implementation to ensure zero harm to patients. He also stressed the importance of evidence-based medicine, particularly in the context of emergency use approvals during the pandemic. Awareness, streamlined regulatory mechanisms, and the proactive involvement of doctors were identified as crucial factors moving forward.

The PvPI, approved by the Union health ministry in July 2010, aims to establish a nationwide system for reporting patient safety issues. It seeks to integrate pharmacovigilance (PV) as an essential component of public health programs for enhanced patient safety. The IPC recently delisted 10 Adverse Drug Reactions Monitoring Centres (AMCs) for non-performance in reporting ADRs. Out of the 701 AMCs across the country, these delisted centers had enrolled between 2015 and 2017 and were removed from the list in March 2023.

The PvPI plays a vital role in monitoring ADRs within the Indian population and collaborates with the global ADR monitoring center, the World Health Organization’s Uppsala Monitoring Centre (WHO-UMC) in Sweden, to contribute to the global ADRs database. NCC-PvPI’s efforts assist the regulatory authority of India, the Central Drugs Standard Control Organization (CDSCO), in making informed decisions regarding the safe use of medicines.

By harnessing digital technologies for ADR reporting and strengthening the PvPI framework, India aims to enhance patient safety, promote evidence-based medicine, and facilitate regulatory decision-making for the safe use of medications.

Source: Shardul Nautiyal, “ADR reporting with technologies can evaluate our capability to detect signals of adverse events: Experts,” Mumbai, Saturday, July 15, 2023, 08:00 Hrs IST.