Reporting ADR: A Step towards patient safety
Adsul Samruddhi Subhash, waable Madhuri Sanjay, Gayke Sanket Ramesh,
Bhand Revannath Narayan, Waghmare sweeti Mohan
Swastyadarpan Pratishthan’s Shantiniketan College of Pharmacy,
A/P Dhotre (B.K.), Tal. Parner, Ahmednagar, Maharashtra, India.
*Corresponding Author E-mail: samuadsul003@gmail.com
ABSTRACT:
In order to fight illness and lessen human suffering, medicine is essential. Pharmaceuticals certainly have therapeutic advantages, but they also carry the risk of Adverse Drug Reactions (ADRs), which are undesirable side effects that can happen at normal dosages. The World Health Organization (WHO) states that adverse drug reactions (ADRs) can cause anything from little discomfort to serious, perhaps fatal consequences. Given India's standing as the "pharmacy of the world," it is critical to have a strong and adaptable pharmacovigilance system in place to protect public health. In India, pharmacovigilance serves as the main framework for identifying, evaluating, disclosing, and averting adverse drug reactions. It places a strong emphasis on post-marketing surveillance to guarantee medications' ongoing safety. To better handle reporting across a large population, the program, which was first run by AIIMS, New Delhi, switched to the Indian Pharmacopoeia Commission in 2011. India's PvPI, which is backed by WHO's worldwide network via the Uppsala Monitoring Centre (UMC) and online resources like VigiFlow and VigiLyze, encourages medical professionals and the general people to report any suspected adverse drug reactions (ADRs), regardless of how severe or unknown they may be. Through mobile applications, toll-free helplines, online forms, and support for vernacular languages, PvPI has made the reporting process easier and more accessible. In addition to improving medication safety profiles, reporting lowers treatment expenses, negative outcomes, and hospital readmissions. To guarantee the safety of medications, a culture of ADR reporting is necessary. Each report helps to safeguard lives and improve the healthcare system.
KEYWORDS: Pharmacovigilance, Adverse Drug Reactions, PvPI, Drug Safety, India Healthcare System.
The primary objective of this study is to highlight the significance of Adverse Drug Reaction (ADR) reporting and the development of a robust pharmacovigilance system in India1. It aims to:
1. Create awarenessamong healthcare professionals and the general public about the importance of monitoring and reporting ADRs2.
2. Emphasize the role of the Pharmacovigilance Programme of India (PvPI) in ensuring the safety and efficacy of medicines post-marketing.3
3. Promote a culture of safety by encouraging timely and accurate ADR reporting to reduce patient morbidity, mortality, and overall healthcare costs4.
4. Demonstrate the global and national efforts supported by WHO and the Uppsala Monitoring Centre in strengthening pharmacovigilance infrastructure and practices in India5.
INTRODUCTION:
Without a question, medicine has shown its worth to humanity; it combats disease and pain, which is a blessing. Adverse Drug Reactions (ADRs) are potential risks associated with the use of pharmaceuticals, just as everything has advantages and disadvantages. In most situations, ADRs are mild to severe, strong, and capable of causing abnormalities or even death. According to the World Health Organization (WHO), adverse drug reactions are harmful, unexpected reactions to medications that occur at predetermined, standard dosages. India is referred to as "the pharmacy of the world" since it manufactures a significant quantity of generic pharmaceutical items for the global market6.
For this reason alone, it needs a well-designed healthcare system in which all medical personnel are aware of the potential risks and advantages of the medications as well as the need to monitor and report adverse drug reactions in order to conduct better quality drug testing and ensure patient safety. "Pharmacovigilance" is the functional committee in India that oversees the assessment, detection, comprehension, reporting, monitoring, and prevention of adverse drug reactions7. It addresses any issues related to drugs8.
Post-marketing surveillance is routinely carried out by pharmacovigilance systems to obtain a comprehensive safety profile of medications worldwide9. Any kind of medication-related adverse drug reaction that is recognized or that this system is known to detect. At first, the National Coordination Center (NCC) was run by the All India Institute of Medical Science (AIIMS), New Delhi. Additionally, on April 15, 2011, the Ministry of Health and Family Welfare, Government of India, redesigned the pharmacovigilance program and moved the system to the National Coordination Center at the Indian Pharmacopoeia Commission (IPC), Ghaziabad, in order to carry out adverse drug monitoring in a populous nation like India. PvPI is primarily responsible for playing a significant role in India and encouraging the best possible use of medications in order to prevent adverse drug reactions 10. PvPI is in charge of educating individuals about adverse drug reactions brought on by active pharmaceutical ingredients after they are required to do so11.
Here are some figures on the number of ADR (Adverse Drug Reaction) /ICSR (Individual Case Safety Report) cases reported in India over recent years, as per published sources12. Some years have better data than others; the numbers are increasing 13.
Reported ADR/ICSR Numbers in India by Year:
Time Period/Year|Number of ADR/ICSR Reports| Notes / Sources
· 2011 - 15,729 - ADR reports received by the National Coordination Centre (NCC)14
· 2017 - 70,915 - Reports received by NCC via VigiFlow. |
· Apr 2018 – Mar 2019 | ~ 64,441 | ICSRs for that financial year.15|
· 2020 – 2021 | ~ 52,810 ADRs reported by PvPI during April 2020 to March 2021.16 |
· 2015 (cumulative up to Dec 2015) | ~ 149,000 | Total ADRs reported since inception of PvPI up to that date|17
· As of June 2024 850,000 | Approximate cumulative total ICSRs in the Indian database 18.
What is ADR?
An Adverse Drug Reaction (ADR) is a harmful, noxious, or unpleasant response to a medicinal product19. Adverse drug Reactions (ADRs) are unpleasant or dangerous side effects that occur after taking a medicine or combination of pharmaceuticals and are thought to be caused by the drug20. ADRs can range in intensity from moderate and bearable to severe and potentially fatal.21
Fig No : 1 Various Adverse Drug Reaction
Pharmacovigilance System Development with WHO Support:
Since ADRs are a major factor in hospital admissions worldwide, monitoring medications and their associated adverse drug reactions (ADRs) is a crucial duty for all health care professionals (HCPs)22. As a result, PV is a crucial component of health care systems around the world23. The first organized international attempts to address the problem of drug safety were not started until the Thalidomide accident in 196124. WHO took it seriously and established the Programme for International Drug Monitoring (PIDM) in 1968.25
The Uppsala Monitoring Centre (UMC), Sweden, is in charge of international drug monitoring and operates as a WHO-Collaborating Centre (WHO-CC) with technical assistance and direction from WHO26. To collect the information on the safety profiles of medicines, UMC has developed web-based tools such as VigiFlow and VigiLyze.27 These tools can seamlessly support data entry, retrieval, and analysis of DSI. Utilizing these tools, member countries are able to assess and communicate risk-benefit profiles of their medical products.28 UMC also helps to support developing a culture of PV practice in member countries through consultation and training29.
Adverse Drug Reaction Monitoring in India:
Reporting adverse drug reaction caused by a marketed drug is the prime responsibility of healthcare professionals with respect to public health and improving safety, not only healthcare professionals but also all the citizen of India should be aware to adverse drug reaction and its reporting. PvPI influence to report any types of suspected adverse drug reaction associated with pharmaceutical products, does not matter it is familiar or unfamiliar, severe or mild and frequent or rare, if anyone facing adverse drug reaction then immediately, they should report. If there are any events occurred with respect to a particular drug, during the healthcare professional attending the patients, the healthcare professional can fill up the suspected adverse drug reaction form and report to AMC. At the same time, the patients also can report the adverse drug reaction by visiting the nearest AMC under PvPI30. The details of AMCs are available in the official website of IPC31. For healthcare professionals to report the ADRs, there is a form called “Suspected Adverse Drug Reaction Reporting Form” available which is given in ‘link 1’ and for patients, family members of patients and relative / any citizen of India can fill the “Medicines side effect reporting form” by clicking on the ‘below link ’. Patients The html is also available for consumers to send to nearest AMCs or directly to NCC. Meanwhile, patients can also report adverse drug reactions by going to the closest AMC under PvPI; the IPC's official website has information on AMCs. Healthcare professionals can report ADRs using the "Suspected Adverse Drug Reaction Reporting Form," which is found at "link 1.", their family members, relatives, and any Indian citizen can fill out the "Medicines side effect reporting form" by clicking on "link 2." Clients can also send the HTML form to the nearest AMCs or directly to NCC, and there is an official email address available for reporting any kind of adverse drug reaction.32
A toll-free hotline number that connects to AMCs to report adverse drug reactions is also available to make reporting simple.33 There is a smartphone application for digital reporting that can be found in the Google Play Store.
www.ipc.gov.in is the IPC's official website.
The following file is the first link: https://cdsco.gov.in/opencms/export/sites/CDSCO_WE B/Pdf-documents/Consumer_Section_PDFs.
The one at the top is the second link.
Official email addresses are ipclab@vsnl.net or pvpi@ipcindia.net.
Number toll-free: 1800-180-3024.
"ADR PvPI" is a mobile app for Android users.34
Importance of Building ADR reporting Culture:
Report ADRs for better understanding of the risk associated with the use of medicines and to safeguard the health of population35
ADR Reporting Approaches
Why ADR Reporting is crucial?
ADR Reporting reduce patient mortality and severe outcomes, re-admissions to hospitals, overall hospital expenses and future ADR incidences & improve the quality of patient care36
What may I report?
These are regarded as adverse medication occurrences that need to be reported to the reporting centers or the closest hospital.37 Death and fatal incidents.38 If individuals are admitted to the hospital as a result of a medication side effect39. Abnormality in the fetus caused by a particular medication. If a healthcare provider believes that a certain health occurrence is hazardous. if the medications are ineffective. any suspected drug activities.40
Regardless of whether a proven causal link between a drug and the reaction has been established, PvPI supports the reporting of all suspected adverse drug reactions (ADRs), regardless of whether they are known, unknown, serious or nonserious, common or rare. It is possible to report adverse drug reactions (ADRs) associated with the use of contrast media, medical equipment, vaccinations, allopathic medications, and traditional medicines.41
Fig No.2 Overview of ADR Monitoring in India
Where to File a Report:
ADRs may be reported to NCC or AMCs by patients or consumers as well as by any healthcare provider, including physicians, dentists, pharmacists, and nurses42. NC can also receive individual case safety information from pharmaceutical companies.43
When should I report?
Any impromptu occurrences were to be reported within ten days44 Reporting any suspected adverse medication occurrence as soon as feasible is necessary. Any unfortunate mortality brought on by an adverse response needs to be reported right away. Within a week, any more negative medication responses should be recorded. Within 30 days, any non-serious adverse medication reactions should be recorded. Delays in reporting cause extra issues. Therefore, as much as feasible, the best course of action is to report right away.45
Who is able to report?
When it comes to reporting adverse drug reactions, health care providers are given priority. like doctors and other health professionals.46
dentist and pharmacist. If an adverse drug reaction occurs as a result of a particular medication or medical device, Indian citizens are also able to report it 47.
Fig No .3: Who Can Reort ADR
How do I report?
Healthcare practitioners might use a form known as the "Suspected Adverse Drug Reaction Reporting Form." (As stated in "Indian adverse drug reaction monitoring") The "Medicines Side Effect Reporting Form," which is provided under "adverse drug reaction monitoring in India," is what customers can use. 48
The IPC website offers How to Report Suspected ADR reporting forms [Figure 5] for consumers and healthcare professionals to report ADR. 49 (Hindi, Tamil, Telugu, Kannada, Bengali, Gujarati, Assamese, Marathi, Oriya, and Malayalam) in order to eliminate the language barrier associated with ADR reporting. Additionally, ADRs can be submitted by calling the PvPI helpdesk (18001803024) between 9:00 am and 5:30 pm on weekdays. The public now has access to the ADR reporting mobile Android application 50
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How to report ADR ? • Steps: Recognize symptoms : Notice something unusual after taking your medication ? • Contact Your Doctor • Use official online platforms or app • Call to Action: Message: join the movement for safer medications, Report any side effects today |
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§ Toll Free No: PvPI -1800 180 3024 § Android App –ADR PvPI App § Email ID : pvpi.ipc@gov.in § Website : www.ipc.gov.in |
Fig No 4 How to report ADR
Overcoming Barriers to reporting ADR :
· It is easy & only takes few minutes .
· It is anonymous, your personal information stays private
· It is makes difference , every report counts toward a safer healthcare system 51
FIG NO 5. suspected adverse drug reaction reporting form
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RREPORTING ADRs IS NOT JUST A RESPONSIBILITY, IT IS A POWERFUL STEP TOWARDS ENSURING A SAFER AND HEALTHEIR FUTURE FOR ALL ….. |
CONCLUSION :
We concluded that ,“ ADR Reporting is vital for patient safety, reducing risks and building a safer healthcare system for all”
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Received on 01.10.2025 Revised on 27.10.2025 Accepted on 19.11.2025 Published on 10.04.2026 Available online from April 13, 2026 Asian J. Res. Pharm. Sci. 2026; 16(2):161-166. DOI: 10.52711/2231-5659.2026.00025 ©Asian Pharma Press All Right Reserved
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