Spontaneous reporting of adverse effects/reactions/experiences of medicinal products is quite essential for generating the safety information of a medicine (for both new & well established medicinal products).
Voluntary side effects reporting is a significant source for real world drug safety experience. A transparent benefit risk profile for a pharmaceutical medicinal product can be achieved through a strong evident data generated from public source.
Unfortunately, the reporting rate of adverse reactions are not in proportion to the total number of exposed patients/consumer to the medicines side effects. It is a global issue in the field of drug safety since decades.
It assists in the identification of rare and serious adverse reactions which are not observed in clinical trail studies. This mode of reporting had potential to largely contribute with huge number of Individual case safety reports (ICSR) and helps in robust analysis of benefit risk ratio of a medicinal product. The benefit risk assessment with strongly evident safety data would yield a benefit risk ratio which is transparent and trustworthy. This can lead to early pickup of medicinal products with negative benefit risk ratio from market for appropriate action by Manufacturer or regulatory body, thereby protecting the public from potential safety hazards or unusual significant safety concerns.
Pharmaceutical products with unacceptable benefit risk profile and which are not having standard quality should not find place in the Indian pharma market. Voluntary side effect reporting is the major source of safety information which could support for the correct benefit risk ratio assessment.
The “Non-participation/reporting of medicine side effects from patients/users is leading to under-reporting which is a global issue. Health authorities (HA) from many countries are taking initiatives to fulfill this lacuna by establishing a standardized reporting process for Drug side effect information collected from health care professionals, consumers and patients which include user friendly adverse event/adverse drug reaction reporting forms, toll-free help line numbers to report adverse effects and creating awareness for the same.
Indian regulatory body also took initiative for establishing Spontaneous ADR reporting in the country assisted by Indian Pharmacopoeia commission (IPC)-Ghaziabad as National coordinating center. The name of this initiative is Pharmacovigilance programme of India (PvPI).
All Indian Citizens are encouraged to report the medicinal product side effects by the following reporting channels.
- By calling to toll-free helpline number 1800-180-3024
- Filling medicinal product side effect form and reporting to nearby adverse drug reaction monitoring center. Forms available at (https://ipc.gov.in/PvPI/)
- Download the mobile app- ADR PvPI