With a view to augmenting government’s plan to roll out the pharmacovigilance programme of India (PvPI) at district level hospitals, around 40 ADR monitoring centres (AMCs) were identified at district hospitals and medical colleges in the country last year, mostly from the Northern and North-Eastern states which marks a positive step towards strengthening the PvPI.

Indian Pharmacopoeia Commission (IPC) is in the process of identifying more such district hospitals which wish to participate as ADR monitoring centres (AMCs) under the PvPI at district level.

The Union health ministry is planning to increase the number of ADR monitoring centres (AMCs) from the current 250 to 300 this year towards patient safety. This will increase ADR monitoring centres in the country to get pan India ADR information, which will further be taken forward in all hospitals of the country so that it could further be implemented at PHC and taluka- level health centres.

As of today, there are in total 250 AMCs in the country. Around 40 AMCs have recently been identified at district hospitals based in the North Eastern part of India, Uttar Pradesh and Himachal Pradesh to get pan India ADR information.

Says a senior official associated with the development, “The expansion though is based on the letter of intent received from the interested healthcare institutions, Ghaziabad-based IPC under the Union health ministry is aggressively planning to explore possibilities of identifying district hospitals across the country to be developed as ADR monitoring centres.”

Medical colleges, hospitals and institutes approved by the Medical Council of India (MCI) can act as AMCs. Once enrolled, they are required to efficiently collect the adverse event information from the patients, do follow up with them to check the completeness of the ADR reports.

IPC which is the national coordination centre (NCC) for PvPI serves as a nodal agency for the AMCs. The registered AMCs across the country play an important role in timely reporting of adverse drug reaction to IPC. Once enrolled, NCC provides logistical and technical support to AMCs for their smooth functioning.

Technical data associates (TDAs) collect information from the patients, perform follow up with them, enter information in the prescribed software (Vigiflow) and sending them to IPC for further analysis and documentation. The TDAs working under PvPI currently get support from the pharmacology division of the respective medical institutions to carry out their functions as part of the programme.

IPC has been assigned to update information on ADRs that is being reported in India from across all its centres through Vigiflow software to the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO's collaborating centre for international drug monitoring.

Union health ministry has also asked AMCs across the country to report serious adverse events during the course of usage of a medical devices as part of the MaterioVigilance Programme of India (MvPI).

The MvPI is meant to enable safety data collection in a systematic manner so that regulatory decisions and recommendations on safe use of medical devices for India could be based on data generated in India. This will also lead to taking systematic measures for common issues confronting the industry. The programme is unique in the sense that it requires inputs in biomedical engineering unlike in medicines where the mechanism is different for reporting of adverse drug reaction (ADR) reporting.

To ensure safety of medical devices through seamless reporting of adverse events due to medical devices, the Indian Pharmacopoeia Commission (IPC) has also launched a reporting form for MvPI. The reporting form called as Medical Device Adverse Event reporting form (MDAE) will help generate independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.

The release of reporting form which has undergone series of scientific consultations, stakeholder meetings with industry and inputs from scientists across the country will ensure safety of medical devices through reporting of adverse events due to medical devices in India.

The reporting form includes adverse event details, severity of the event, date, location, device category, model of the device available with the organisation, its use after the event, name of medical device, manufacturer, brand name, model number, serial number, batch number, catalogue number for instruments, date of installation/ implantation/ explanation and list of accessories among other relevant details like actions taken immediately after the incident/event.

Health ministry has also asked AMCs to set up causality assessment committee in each of the 250 AMCs functioning across the country to bring clarity on PvPI towards patient safety.

This is urgently required as this will effectively help in establishing clinical evidence between the drug and the adverse drug reaction or serious adverse event associated with it in the patient. Each existing AMC has been mandated to follow the same in the interest of patient safety, informed a senior official associated with the development.

Causality or related assessment implies determination of whether there is a reasonable possibility that the product is causally related to the adverse event. Causality assessment includes evaluation of temporal relationships, association with or lack of association with underlying disease, presence or absence of a more likely cause, and biologic plausibility.

It should be emphasized that manufacturers should not separate out those spontaneous reports they receive into those that seem to themselves to be causally related to drug exposure and those they consider not causally related. A physician in making a spontaneous report to a manufacturer is indicating that the observed event may be due to the drug, i.e. the physician suspects that the event is a reaction.

As a practical matter, many companies do causality assessments on spontaneous reports as part of their signal analysis mechanisms.

IPC has recently come out with draft protocol and guidelines focused on targeted drugs and events as a part of Intensive adverse drug reaction monitoring exercise under PvPI so that appropriate action can be taken on specific drugs involving adverse events or reactions.

The intensive ADR monitoring protocol which has recently been devised will be implemented in an ongoing manner based on the learnings of the projects undertaken with help from competent institutions. This will help in taking regulatory decisions in a timely manner.

Institutions have been identified and encouraged in the country to carry out intensive ADR monitoring as per the guidelines for reporting specific events in a focused manner related to a specific drug.