PvPI Asks Stakeholders To Report ADRs Due To Irrational Usage Of Nutraceuticals

Mumbai, 26 Sept 2019:

In view of the increasing incidences of adverse drug reactions (ADRs) due to irrational usage of nutraceuticals, the Pharmacovigilance Programme of India (PvPI) has urged the stakeholders to utilise channels of reporting ADRs developed by Indian Pharmacopoeia Commission (IPC).

Indian Council of Medical Research-National Institute of Nutrition (ICMR-NIN), Hyderabad is one of the PvPI collaborating centres for monitoring the safety of nutraceuticals.

Currently, PvPI receives a very limited number of ADRs related to the use of nutraceuticals, health and food supplements.

Therefore, it has been urged to all stakeholders including clinicians, nurses, pharmacists, other allied health workers and public to report all adverse events associated with nutraceuticals, health and food supplements.

PvPI has urged to utilise channels of reporting such events like PvPI Forms (Suspected ADR Reporting Form/ Medicines Side-Effects Reporting Form), Emai address - (icsr.nccpvpi@gmail.com), (pvpi.compat@gmail.com), PvPI Helpline (1800-180-3024) and Mobile App (ADR PvPI).

Ghaziabad based IPC is functioning as a National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) launched in 2010.

Last year, the Union health ministry came out with suspected ADR form for healthcare professionals for reporting adverse drug reactions (ADRs) towards focused Pharmacovigilance (PV). It also came out with medicines side-effect reporting form for approved drugs in the country besides a toll free helpline number in the interest of patient safety.

Union health ministry has also tasked 270 ADR Monitoring Centres (AMCs) existing in the country to establish clinical evidence between the drug and the adverse drug reaction through a robust system of causality assessment.

Central Drugs Standard Control Organisation (CDSCO) in collaboration with IPC had in the past also started auditing healthcare institutions through assessment on aspects like SOPs and causality assessment in order to review the functioning of AMCs in the country.

The exercise was meant to generate awareness in medical institutions to put in place effective surveillance system for detection of ADRs

PvPI National Scientific Co-ordinator Dr Y K Gupta has also sought stakeholders views on whether adverse effects due to nutraceuticals should be treated on par with that of drugs and what should be the technical nomenclature for the sake of implementing it with clarity.

In a mail addressed to the stakeholders on safe use of nutraceuticals, PvPI stated, “As you all are aware that the use of nutraceuticals, health supplements and foods for special dietary purposes is now widespread among the urban as well as rural populace in India. Incidence of ADRs due to use of nutraceuticals in the past have therefore raised concerns for regularly monitoring safety of these products.” Pharmabiz