IPC launches benefit risk assessment cell for drugs under PvPI

IPC launches benefit-risk assessment cell for drugs under PvPI
Feb, 2016

The Indian Pharmacopoeia Commission (IPC) recently launched the benefit-risk assessment cell for drugs under the risk management plan (RMP) of the Pharmacovigilence Programme of India (PvPI). Experts associated with the proceedings inform that the overall goal of the RMP is to assure a positive risk-benefit profile once the drug has been marketed.

The Health minister had recently inaugurated the plan which describes the risks i.e. adverse drug reactions associated with the use of drugs and how they are being handled, with warning on the drug label or in packet insert about possible side effects.

Dr V Kalaiselvan, Principal Scientific Officer informs that the main aim behind coming out with this initiatives is to minimise the risks while maximising the beneficial effects of a medicine by ensuring its proper use by the patients. “With this, we have achieved a strategic milestone with respect to strengthening the PvPI initiatives, as it will further ensure better patient centric measure. Under this initiative, if the overall balance of benefits and risks are judged to be negative, then the medicine may be withdrawn, unless risk reduction strategies can be identified which would swing the balance away from risk,” Dr Kalaiselvan informed.

This cell will enable IPC, which acts as the National Coordinating Centre (NCC) for the PvPI to continue to passively monitor various issues, i.e. it is appropriate for non-serious adverse events, where causality is not established. Similarly, actively collect further data, if causality is not established, mechanism unclear, or where risk-factors are not identified.

It will also aid in taking requisite decisions on adding warnings to the product label, for less serious adverse effects, particularly which are unavoidable, where warning health care professionals and patients may be the only action necessary. Assist in ensuring changes to the product label to reduce risk: restrict the indication; contraindicate those at greater risk, advice monitoring, etc. Interestingly, the cell also enables to monitor effects of action taken so as to ensure that they are effectively contributing to protect public health.

“We have been constantly working with all the stakeholders to collate data, analyse it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public. Through this well thought out plan we plan to improve patient safety and welfare in Indian population by monitoring drug safety and thereby reducing the risk associated with use of medicines. The ultimate safety decisions on medicines may need considerations of comparative benefit and risk evaluations between products for similar indications, so the complexity is great,” he added.

Pharmabiz