ADR reporting with technologies can evaluate our capability to detect signals of adverse events: Experts

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Adverse drug reactions (ADRs) reporting with the help of digital technologies will give us the opportunity to evaluate our capability to detect signals of adverse events. This will also help us in taking regulatory decisions effectively in a time bound manner towards patient safety, experts said on the sidelines of the 9th International Pharmaceutical Exhibition (iPHEX) held in Hyderabad recently. The event was organized by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with support from the Union commerce ministry between July 5 and July 7, 2023. Dr Viranchi Shah, national president, Indian Drug Manufacturers’ Association (IDMA) moderated a session on the same.

Ghaziabad based Indian Pharmacopoeia Commission (IPC) had rolled out a suspected ADR reporting form in physical format for voluntary reporting of ADRs by healthcare professionals three years ago as a part of the Pharmacovigilance Programme of India (PvPI).

IPC, which is The National Coordination Centre (NCC) for PvPI, had also rolled out a medicine side effect reporting form to report ADR for consumers and patients. As a part of the roll out, a Toll Free PvPI Helpline -1800-180-3024 had also been launched for the public from Monday to Friday between 9:00 am to 5:30 pm.

According to Dr Ranga Reddy Burri, president, Infection Control Academy of India (IFCAI), “As of today 80% of MSMEs are not under the fold of PvPI. Unless we are going to make PvPI stricter and make ADRs universally applicable, we cannot ensure zero harm to the patient due to ADRs. Evidence based medicine has taken a beating during the pandemic with reference to the emergency use approval or authorization. We should know the framework in which we are going to use it. This requires awareness, streamlining of regulatory mechanisms and the proactive role of doctors going forward.”

The PvPI was approved by the Union health ministry in July 2010 with the primary objective to create a nation-wide system for patient safety reporting. PvPI envisages integrating pharmacovigilance (PV) as an essential component of public health programmes (PHPs) for patient safety.

The IPC recently delisted 10 Adverse Drug Reactions Monitoring Centres (AMCs) out of the 701 AMCs from across the country because of non-performance in reporting ADRs. The years of enrolment of these delisted AMCs were between 2015 and 2017 and date of joining was in March 2023.

The PvPI was launched with a broad objective to safeguard the health of people in India. ADRs are reported from all over the country to NCC-PvPI, which also works in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute to the global ADRs database. NCC-PvPI monitors the ADRs among the Indian population and helps the regulatory authority of India (CDSCO) in taking decisions for safe use of medicines.

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