Drugs safety and adverse drug reaction reporting in Manipur
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Dr Neerajkumar Sharma Manohar
Manipur’s healthcare community is increasingly focusing on adverse drug reactions (ADRs) and Phar-macovigilance, with several medical institutions actively contributing through ADR reporting to their respective Adverse Drug Reaction Monitoring Centres (AMCs).
Awareness campaigns, particularly during National Pharmacovigilance Week starting from 17 to 23 September every year from 2021, have reinforced the importance of drug safety among both healthcare professionals and the general public.
According to the World Health Organization (WHO), an ADR is “a response to a drug which is noxious and unintended and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.” In India, ADR reporting operates through the Pharmaco-vigilance Programme of India (PvPI) managed by the Indian Pharmacopoeia Co- mmission (IPC) in Ghaziabad.
Manipur’s Progress So Far
Shija Academy of Health Sciences (SAHS), Langol, Manipur, together with Shija Hospitals and Research Institute Pvt. Ltd. (SHRI), has successfully celebrated National Pharmacovigilance Week for four consecutive years since becoming an ADR Monitoring Centre in 2022. The 5th National Pharmacovigilance Week in 2025, carrying the theme "Your Safety, Just a Click Away: Report to PvPI," was also commemorated with essay writing, interactive sessions, quiz competitions, skit presentations, and hands-on training for physicians, interns, nurses, pharmacists and other allied health staff of SAHS and SHRI. At present, Manipur has four such centres — at SAHS, Regional Institute of Medical Sciences (RIMS) Imphal, Jawaharlal Nehru Institute of Medical Sciences (JNIMS) Porompat, and Babina Hospital, Manipur.
Even after a drug is released in the market, it remains under Phase IV clinical trial, also known as post-marketing surveillance. This phase is crucial for identifying rare or unexpected side effects that may not have surfaced during earlier trials. Variations in pharmacogenomics, dietary habits, regional demographics, etc., can all influence how drugs perform in different populations.
ADR reports from India are submitted using the Individual Case Safety Report (ICSR) or ADR Form (currently version 1.4) available on the IPC website. These reports are uploaded into the VigiFlow system and then encoded in VigiBase, the global database managed by the Uppsala Monitoring Centre (UMC) in Sweden. This data aids UMC and regulatory authorities and pharmaceutical companies to take corrective measures when necessary.
As of 2024, India ranks third among Asian countries as a preferred site for clinical trials, generating revenue of US $207.7 million.
Challenges in Reporting
Despite these systems, ADR reporting in Manipur remains low compared to other States. Studies have highlighted key barriers, such as the fear of losing professional reputation, concerns about patient reactions, and a lack of awareness about the confidentiality of reports.
It is worth noting that the ADR form itself assures complete confidentiality: “The patient’s identity is held in strict confidence and protected to the fullest extent. Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the reaction.”
Additionally, irrational drug use and easy access to over-the-counter (OTC) medications — despite prescription-only regulations — contribute to the problem.
Institutional Efforts
At SAHS, several initiatives aim to improve drug safety and rational use, including the Antibiotic Stewardship Program, Pharmacy Advisory Committee, and Pre-Authorisation Committee. These are guided by the principles of Rational Use of Medicines and the National List of Essential Medicines (NLEM).
A dedicated Pharmacovigilance Committee at SAHS oversees ADR reporting and ensures proper follow-up. Beyond drug safety, the PvPI also coordinates related initiatives such as the Materiovigilance Programme of India (for medical devices), Haemovigilance Programme of India (for blood products), and monitoring of Adverse Events Following Immunization (AEFI).
Policy and Practical Steps Forward
Training Modules: Introduce short, mandatory pharmacovigilance sessions for consultants, interns, nursing staff, pharmacists,etc with hands-on ADR reporting practice.
Simplified Reporting: Establish visible, easy-to-use reporting routes in hospitals — via QR codes, intranet links, or mobile forms.
Focal Persons: Appoint a pharmacovigilance associate at each tertiary centre to mentor teams and monitor reporting performance.
Feedback Loops: Use local ADR data to publish short hospital bulletins summarizing key findings and preventive measures.
Curriculum Integration: Embed pharmacovigilance and ADR reporting into postgraduate, undergraduate and internship training.
Regulatory Vigilance: Strengthen the role of the state drug controller to address irrational dispensing and antibiotic misuse.
The Road Ahead
Manipur already has the essential building blocks for a robust drug-safety surveillance system — engaged hospitals, local research, and increasing awareness. The next challenge is to turn awareness into routine, timely, and accurate reporting.
With modest investment in training, digital reporting tools, and dedicated institutional champions, Manipur’s healthcare system can significantly strengthen ADR detection and patient safety — benefiting not only local patients but also contributing to India’s national pharmacovigilance mission.
The writer is Convener-cum-Coordinator, Adverse Drug Reaction Monitoring Centre (AMC), PvPI, Assistant Professor, Dept. of Pharmacology, Shija Academy of Health Sciences (SAHS), Langol, Email : [email protected]
Manipur’s healthcare community is increasingly focusing on adverse drug reactions (ADRs) and Phar-macovigilance, with several medical institutions actively contributing through ADR reporting to their respective Adverse Drug Reaction Monitoring Centres (AMCs).
Awareness campaigns, particularly during National Pharmacovigilance Week starting from 17 to 23 September every year from 2021, have reinforced the importance of drug safety among both healthcare professionals and the general public.
According to the World Health Organization (WHO), an ADR is “a response to a drug which is noxious and unintended and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.” In India, ADR reporting operates through the Pharmaco-vigilance Programme of India (PvPI) managed by the Indian Pharmacopoeia Co- mmission (IPC) in Ghaziabad.
Manipur’s Progress So Far
Shija Academy of Health Sciences (SAHS), Langol, Manipur, together with Shija Hospitals and Research Institute Pvt. Ltd. (SHRI), has successfully celebrated National Pharmacovigilance Week for four consecutive years since becoming an ADR Monitoring Centre in 2022. The 5th National Pharmacovigilance Week in 2025, carrying the theme "Your Safety, Just a Click Away: Report to PvPI," was also commemorated with essay writing, interactive sessions, quiz competitions, skit presentations, and hands-on training for physicians, interns, nurses, pharmacists and other allied health staff of SAHS and SHRI. At present, Manipur has four such centres — at SAHS, Regional Institute of Medical Sciences (RIMS) Imphal, Jawaharlal Nehru Institute of Medical Sciences (JNIMS) Porompat, and Babina Hospital, Manipur.
Even after a drug is released in the market, it remains under Phase IV clinical trial, also known as post-marketing surveillance. This phase is crucial for identifying rare or unexpected side effects that may not have surfaced during earlier trials. Variations in pharmacogenomics, dietary habits, regional demographics, etc., can all influence how drugs perform in different populations.
ADR reports from India are submitted using the Individual Case Safety Report (ICSR) or ADR Form (currently version 1.4) available on the IPC website. These reports are uploaded into the VigiFlow system and then encoded in VigiBase, the global database managed by the Uppsala Monitoring Centre (UMC) in Sweden. This data aids UMC and regulatory authorities and pharmaceutical companies to take corrective measures when necessary.
As of 2024, India ranks third among Asian countries as a preferred site for clinical trials, generating revenue of US $207.7 million.
Challenges in Reporting
Despite these systems, ADR reporting in Manipur remains low compared to other States. Studies have highlighted key barriers, such as the fear of losing professional reputation, concerns about patient reactions, and a lack of awareness about the confidentiality of reports.
It is worth noting that the ADR form itself assures complete confidentiality: “The patient’s identity is held in strict confidence and protected to the fullest extent. Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the reaction.”
Additionally, irrational drug use and easy access to over-the-counter (OTC) medications — despite prescription-only regulations — contribute to the problem.
Institutional Efforts
At SAHS, several initiatives aim to improve drug safety and rational use, including the Antibiotic Stewardship Program, Pharmacy Advisory Committee, and Pre-Authorisation Committee. These are guided by the principles of Rational Use of Medicines and the National List of Essential Medicines (NLEM).
A dedicated Pharmacovigilance Committee at SAHS oversees ADR reporting and ensures proper follow-up. Beyond drug safety, the PvPI also coordinates related initiatives such as the Materiovigilance Programme of India (for medical devices), Haemovigilance Programme of India (for blood products), and monitoring of Adverse Events Following Immunization (AEFI).
Policy and Practical Steps Forward
Training Modules: Introduce short, mandatory pharmacovigilance sessions for consultants, interns, nursing staff, pharmacists,etc with hands-on ADR reporting practice.
Simplified Reporting: Establish visible, easy-to-use reporting routes in hospitals — via QR codes, intranet links, or mobile forms.
Focal Persons: Appoint a pharmacovigilance associate at each tertiary centre to mentor teams and monitor reporting performance.
Feedback Loops: Use local ADR data to publish short hospital bulletins summarizing key findings and preventive measures.
Curriculum Integration: Embed pharmacovigilance and ADR reporting into postgraduate, undergraduate and internship training.
Regulatory Vigilance: Strengthen the role of the state drug controller to address irrational dispensing and antibiotic misuse.
The Road Ahead
Manipur already has the essential building blocks for a robust drug-safety surveillance system — engaged hospitals, local research, and increasing awareness. The next challenge is to turn awareness into routine, timely, and accurate reporting.
With modest investment in training, digital reporting tools, and dedicated institutional champions, Manipur’s healthcare system can significantly strengthen ADR detection and patient safety — benefiting not only local patients but also contributing to India’s national pharmacovigilance mission.
The writer is Convener-cum-Coordinator, Adverse Drug Reaction Monitoring Centre (AMC), PvPI, Assistant Professor, Dept. of Pharmacology, Shija Academy of Health Sciences (SAHS), Langol, Email : [email protected]