Adverse event reporting tools and regulatory measures in India through outcome of Pharmacovigilance Programme of India.

The primary care medical practitioners as well as common public must be made aware of the importance and benefits of reporting adverse drug reactions (ADRs). The reporting of ADRs through periodic safety update reports is a regulatory requirement in many countries including India, however, the importance of ADR reporting through spontaneous reporting system cannot be ignored. After the initiation of Programme for International Drug Monitoring, WHO-Uppsala Monitoring Centre (UMC), Sweden, succeeded in establishing a worldwide pharmacovigilance (PV) network in >150 countries. As a full member of this program, India also has developed a robust PV system through Pharmacovigilance Programme of India (PvPI) involving its various ADR Monitoring Centers and after due quality check of Individual Case Safety Reports (ICSRs), submits this information to UMC through a web-based tool VigiFlow®. This information is then stored into VigiBase® which is the repository of worldwide ICSRs. Based on the drug safety information collected, PvPI issues alerts, recommends label change (if any), and identifies signals thereby supporting National Regulatory Authority. At national level, PvPI has developed several tools for reporting of ADRs by the stakeholders. This article provides an overview of adverse events reporting tools in India vis-a-vis selected countries around the world, based on a comparative literature search. This article also throws light upon the regulatory aspects of PV in India, findings of PvPI and its recommendations to Central Drugs Standard Control Organization, collaboration of PvPI with Public Health Programmes, future prospects of reporting ADRs in India and how it will help enhance the quality of ADR-reporting by citizens of India.

Introduction

Any drug that is developed, manufactured, and marketed for sale, when given at therapeutic dose level may also cause some undesirable effect(s) along with its benefits. These undesirable effects are referred to as adverse effects. An adverse event/adverse experience (AE)may not necessarily be an adverse drug reaction (ADR) unless checked for its causality using various causality assessment scales.[1] In an elementary way, an ADR can be explained as any unwanted reaction observed after consumption of a pharmaceutical product at a normal dose and can occur due to many variable factors such as alteration of dose regimen, introduction of erroneous medication, consumption of substandard medicines, and patient's existing medical history with a particular drug. Many studies have shown that ADRs are more common in patients taking several medications concomitantly, either because of drug hypersensitivity/allergy to drug or excipients in the product or drug–drug interactions or because of change of Pharmacokinetics and Pharmacodynamic of the drug, or due to other factors such as diseases or simply because of hereditary factor, age, sex, or gender.[2] Hence, minimizing the incidence of ADRs is of utmost importance to safeguard patient's life from serious and life-threatening AEs and also to avoid economic burden.[34] This is possible through Pharmacovigilance (PV) by monitoring any ADR occurring due to administration of any pharmaceutical product, gathering the information on patient's medication/medical history, concomitant drugs/diseases and drug interactions as well as by counseling the patients.[5]

PV is a specific domain of pharmacological sciences that deals with the drug safety information (DSI) of medicinal products. It is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problem.[67] There are reviews available on PV in India[8] however, with the march of time, the available information requires updating on various fronts.

Keeping this in mind, the present review article provides a comprehensive overview on the regulatory aspects of PV, available methods, and tools of reporting ADRs in India vis-à-vis selected countries around the world. This article also details the regulatory measures taken in India based on Pharmacovigilance Programme of India (PvPI) outcome, future prospects of reporting ADRs in India and how it will help enhance the quality of ADR reporting by citizens of India.

Evolution of Pharmacovigilance System with Support of WHO

Monitoring of medicines and their respective ADRs is an essential responsibility of all Health-Care Professionals (HCPs) since ADRs are the cause of concern for hospital admissions in different parts of the world and therefore PV is an integral element of health-care systems globally.[9] It was not until the disaster caused by Thalidomide in 1961, that the first systematic international efforts were initiated to address drug safety issue.[7] Taking serious note of it, in 1968, WHO launched a Programme for International Drug Monitoring (PIDM).[10]

With the technical guidance and support from WHO, the Uppsala Monitoring Centre (UMC), Sweden functions as a WHO-Collaborating Centre (WHO-CC) and is responsible for International Drug Monitoring. Under the ambit of WHO-UMC, there are 139 member countries that have presently undertaken the responsibility of reporting ADRs to UMC along with 31 associate member countries those are in the early stages of developing their PV systems.[11]

To collect the information on the safety profiles of medicines, UMC has developed web-based tools such as VigiFlow® and VigiLyze®. 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. UMC also helps to support developing a culture of PV practice in member countries through consultation and training.[12]

Regulatory Aspects of Pharmacovigilance in India

The sustainability of a particular drug in the market depends on its safety profile which may change over time on account of various reasons including how many patients exposed to a particular drug and therefore PV of medicinal products is considered as an essential requirement in pharmaceutical industries which operate within regulatory environment and report DSI to the respective Drug Regulatory Authorities (DRAs).[13]

During the last decade, many drug regulatory reforms have been introduced in India. Briefly, the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder has a mandate to regulate the import, sale, manufacture, and circulation of drugs and cosmetics in India. Under various provisions of this statutory law, several attempts have been made in recent years to protect the rights, safety, and well-being of a subject/patient enrolled in a clinical trial. One of the important programs, which have become adaptive and popular, is PvPI. Its various specific tools are widely used by the manufacturers, MAHs, regulators, HCPs, and patients for the reporting of adverse event(s) of the drugs being manufactured/marketed/imported into the country for use by Indian population. Some of the regulatory reforms consist of amendment in Schedule Y of Drugs and Cosmetic Rules, 1945 to include of PV system for drugs manufactured or marketed by the applicant in the country, compensation from clinical trial injury to the trial subject, registration of ethics committee, etc.[1415]

According to the Schedule Y of Drugs and Cosmetics Rules 1945, the clinical trial of a new drug has to be conducted as per the requirements of Good Clinical Practices prescribed therein; this necessitates documentation of ADRs that are being observed before and after marketing of the drugs in the country. This Schedule strictly enforces laws on manufacturers to report any ADR being caused by their drug: whether it is before marketing or after the launch of the drug in market.[16]

In addition to this provision, the clause 28 (2) of schedule M of the Drugs and Cosmetics Act 1940 and Rules 1945 mentions that the “reports of serious adverse drug reactions resulting from the use of a drug along with comments and documents shall be forthwith reported to the concerned licensing authority.”[17]

The quality of drug is another important attribute in the determination of its safety and efficacy. The regulation of medical products by the Ministry of Health and Family Welfare (MoHFW) and implementation of other health-related laws need urgent and concrete steps toward reforms.[18] Recently, New Drugs and Clinical Trials Rules, 2019 (NDCTR, 2019) have been notified vide Gazette notification number 227(E) dated March 19, 2019, and are in force. These new rules are applicable for all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study, and ethics committee. The inclusion of definition of Phytopharmaceutical drugs, in the definition of “New drug” under Rule 2, provisions of Post Marketing Assessment of New Drugs under Fifth Schedule of NDCTR, 2019 as well as registration of bioavailability/bioequivalence study center and emphasis on PV system, are step forward in Indian Drug Regulatory System.[19]

Furthermore, redefining of “New Drug” in the NDCTR, 2019 is also the important change widening the scope of definition of “New Drug” to give broader coverage for ensuring quality and safety of new drugs being marketed in the country.[19] Furthermore, the word 'Drug' is defined as per the section 3 (b)(iv) of Drugs and Cosmetics Act 1940 and includes such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of diseases or disorders in human beings or animals. Therefore the quality and safety of medical devices is also equally important.

In the National Health Policy, 2017 the PV including prescription audit inclusive of antibiotic usage in the hospital and community has been made mandatory to enforce change in existing practices.[20]

It is essential that the DSI needs to be monitored throughout the lifecycle of a medicine.[21] The Individual Case Safety Reports (ICSRs) are one of the important sources of safety data of medicines collected through spontaneous reporting by the HCPs or patients or relatives of the patients or consumers. The other sources such as manufacturers/MAHs may also report DSI through periodic safety update reports (PSURs)/other suitable mechanisms to the DRAs. In respect of every new drug approved for marketing in India, the manufacturers/MAHs of new drugs are bound to submit PSURs to the Central Licensing Authority i.e., the Drugs Controller General of India, Central Drugs Standard Control Organization (CDSCO)-HQ, New Delhi. PSURs submission is also a condition for import of new drugs for sale or distribution in India. To facilitate adverse events reporting, PvPI has initiated requisite training program for skill development on PV for stakeholders including manufacturers/MAHs, from time to time as well as to create awareness among the stakeholders and educate them in this regard. The National Coordination Centre (NCC)-PvPI has brought out a “Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products” which is effective from January, 2018.[22] The PvPI has been receiving an overwhelming response from MAHs for the submission of drug safety profile through E2B-xml file. As of now, >90 MAHs are submitting drug safety profile to PvPI.[23] The monthly contribution by MAHs is shown in Figure 1.

Figure 1

Monthly contribution by MAHs to Pharmacovigilance Programme of India in year 2018

Pharmacovigilance-system in India

PV not only aims to prevent the ADRs due to medicines but also the activities in PV are aimed at spreading the awareness of potential ADRs among common masses. As a part of WHO-PIDM each member country has its own PV system which ensures safe dispensing and use of medicines among its citizens. Taking into consideration various factors that affect the health of Indian citizens, a health-care system operates in India to look after the ADRs that are prevailing due to the use of medicines. To ensure proper reporting of ADRs and to safeguard public health of Indian citizens, CDSCO, MoHFW, Government of India launched the National Pharmacovigilance Programme in November 2004 which was later recognized as PvPI, initially housed at Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi, as the NCC. The MoHFW, Government of India, recasted PvPI on April 15, 2011, and shifted the NCC-PvPI to Indian Pharmacopoeia Commission (IPC), Ghaziabad. However, as on date AIIMS, New Delhi continues to be one of the Adverse Drug Reaction Monitoring Centre (AMC) under the ambit of PvPI.[24]

National Coordination Centre-Pharmacovigilance Programme of India: Regulatory Measures Recommended to Central Drugs Standard Control Organization

In India, it is quite imperative for PvPI to play a key role and promote safe usage of medicines to avoid ADRs. Since its recasting, PvPI is responsible for making people aware about various ADRs caused by pharmaceutical products, this system also encourages people of India to come forward and report ADRs. Currently functioning all around India, with its 311 AMCs, PvPI encourages proper reporting of ADRs through ADR-reporting forms. The sourced data through the suspected ADR-reporting forms is made use for filling up ICSRs online in the WHO database, i.e., VigiFlow®. Information regarding ADRs is first received by PV Associates working under the direct supervision of the Coordinator/Deputy Coordinator at different AMCs, these reports are then validated and assessed for the causality by a team of clinicians, pharmacologists, and PV Associate at individual AMC. Further, the PV Associate at individual AMC submits these reports in the form of ICSRs through VigiFlow® software to NCC. These ICSRs are then processed, reviewed for their quality, scored on the basis of information provided, to NCC, and eventually submitted to UMC, Sweden.[2425]

For reporting of ADRs in India, NCC-PvPI has introduced various convenient seamless and time-saving tools which are useful for HCPs, MAHs as well as for the consumers.[26] The number of ICSRs being received by NCC-PvPI is progressing each year [Figure 2], and the quality also is better as compared to many countries around the world [Figure 3]. Utilizing the safety database, PvPI has also been able to communicate its outcome in terms of safety signals [Table 1] and label changes requirement [Table 2] to CDSCO. In recent years, PvPI has directed its efforts in promoting the ADR reporting, patient education, and regulatory recommendations resulting into an overwhelming support from all the stakeholders including the common masses.[27]

Figure 2

Individual case safety reports received at Pharmacovigilance Programme of India during 2011–2018

Figure 3

Average quality score of individual case safety reports

Table 1

Drug safety signals generated by Pharmacovigilance Programme of India

Drug	ADRs
Cefixime	AGEP
Furosemide	Dermatitis lichenoid
Itraconazole	AGEP
Fluconazole	Hyperpigmentation
Lithium Carbonate	DRESS syndrome
Oseltamivir	Sinus bradycardia/bradycardia

ADRs=Adverse drug reactions, AGEP=Acute generalized exanthematous pustulosis, DRESS=Drug rash with eosinophilia and systemic symptoms

Table 2

Pharmacovigilance Program of India recommendations implemented by Central Drugs Standard Control Organization for package insert update/label change by MAHs

Suspected drug/s	ADRs
Carbamazepine	SJS and TEN
Piperacillin and tazobactam	Hypokalaemia, bronchospasm
Rabies vaccine	Erythema multiforme
Sodium valproate	Gum hyperplasia
Phenytoin	AGEP
Sulfasalazine	SJS, TEN, DRESS Syndrome
Terbinafine	AGEP
Cefotaxime	Angioedema
Ofloxacin	SJS
Tranexamic acid	Seizure/convulsion
Quetiapine	Urinary incontinence
Phenobarbital	DRESS syndrome
Cefepime	Urticaria

SJS=Stevens–Johnson syndrome, TEN=Toxic epidermal necrolysis, AGEP=Acute generalized exanthematous pustulosis, DRESS=Drug rash with eosinophilia and systemic symptoms, ADRs=Adverse drug reactions, MAHs= Marketing Authorization Holders

Besides monitoring the safety of pharmaceutical products, PvPI is also responsible for conducting various other activities to ensure patient safety, such as conducting capacity building workshops for HCPs, organizing, monitoring, and surveillance workshops for PV associates placed at AMCs through its Regional Training Centers and also train delegates of foreign countries to inculcate PV activities in their countries. IPC has also taken the responsibility of conducting various skill development programs (SDPs) to nurture PV culture among PV professionals in the country.[23] A robust system for communication has been adopted to ensure flow of information among various stakeholders of PvPI [Figure 4] and illustrates the channels of data flow in PvPI.

Figure 4

Channels of data flow in Pharmacovigilance Programme of India

UMC is one of the PV Collaboration Centers of WHO, and there are four other collaboration centers, each working in specialized areas of PV. The other four centers are one each in the Netherlands, Morocco, Norway, and Ghana.[28] On July 18, 2017, WHO honored NCC-PvPI, IPC as a WHO-CC for PV in Public Health Programmes (PHPs) and Regulatory Services. PvPI as a WHO-CC provides scientific support to countries in Asia for PV in PHPs such as tuberculosis (TB), neglected tropical diseases, vector-borne diseases, HIV-AIDS, Adverse Event Following Immunization (AEFI), and regulatory issues.[29]

Collaboration of Pharmacovigilance Programme of India with Public Health Programmes

Public health is concerned with the prevention and control of communicable diseases at population level. In this regard, PvPI has collaborated with various PHPs including Revised National Tuberculosis Control Programme (RNTCP), antiretroviral therapy (ART) under National AIDS Control Organization (NACO), AEFI, and National Vector Borne Disease Control Programme (NVBDCP).[23]

Pharmacovigilance in Revised National Tuberculosis Control Programme

Based on the Directly Observed Therapy Short-course, this program was launched in 1997 with a motive of covering the entire India and making it a TB free place.[30] A diagnosed TB patient on treatment under RNTCP takes more than one anti-TB drug simultaneously with regimens lasting from 6 months to 2 years or more. Therefore, ADRs related with anti-TB drugs have been observed quite frequently. To expand the reach of PvPI in this area, on October 11, 2013, NCC-PvPI collaborated with RNTCP to monitor the ADRs occurring due to anti-TB drug therapy. At present, 21 AMCs have been designated solely for monitoring of ADRs related to anti-TB drugs.[31]

Pharmacovigilance in National Vector Borne Disease Control Programme

It is a program specifically aimed at eliminating Leishmaniasis commonly known as Kala-azar that is endemic in a few states of India.[32] Other diseases being covered under this program are Malaria, Dengue, Filariasis, Japanese Encephalitis, and Chikungunya. To monitor the safety of medicines used for the treatment of Leishmaniasis, PvPI stepped up and collaborated with NVBDCP on August 3, 2016, through signing of Memorandum of Undertaking (MoU) at New Delhi to monitor drug safety in vector-borne diseases and to initiate and promote the process for reporting of ADRs with WHO as a technical partner. The roadmap for implementation of PV for vector-borne diseases has been described.[33] At present, there are 58 designated centers in endemic states that monitor safety of drugs used for the treatment of Leishmaniasis.

Pharmacovigilance in National AIDS Control Organization

According to United Nations Programme on HIV and AIDS (UNAIDS), India had 88,000 new HIV infections and 69,000 AIDS-related deaths in 2017.[34] The NACO provides access to quality care for HIV patients and also spreads awareness about safe use of condoms, treatment of sexually transmitted diseases, and responsible sexual behavior.[35] The AIDS is prevalent among sex workers; people who use previously used injections for taking drugs and people who have unprotected sex. The NCC-PvPI, IPC has signed a MoU with NACO on September 15, 2014, with a view to monitor ADRs occurring due to ART. AMC monitors the safety of ART; this safety information is regularly analyzed for generating safety alerts and identifying new signals; furthermore, these reports are submitted to global database.[31]

Pharmacovigilance in Adverse Event Following Immunization

Vaccines provide active immunity to fight against infectious diseases. The immunization program dates back to 1978 in India as “Expanded Programme of Immunization.” In 1985, the program was modified as “Universal Immunization Programme” (UIP) to be implemented in phased manner to cover all districts in the country by 1989–1990 with the one of largest health programs in the world. MoHFW provides several vaccines to infants, children, and pregnant women through the UIP. Various vaccines covered in UIP are BCG, oral polio vaccine, Hepatitis B vaccine, rotavirus vaccine, DPT, tetanus vaccine, etc.[36] The IPC, NCC-PvPI has collaborated with UIP on February 28, 2013, and has taken the responsibility of identifying AEFI.

Tools for Adverse Drug Reactions-reporting

The communication of drugs safety information among HCPs, patients, MAHs, and PV officials is essential for ADR Reporting. To ease this process, NCC-PvPI, IPC has developed several tools for ADR-reporting.

Adverse Drug Reactions Reporting Forms

For the convenience of Indian citizens, NCC-PvPI has launched ADR reporting forms that are posted on the website of IPC (www.ipc.gov.in). The forms can be downloaded, filled, scanned, and sent to nearby AMC or directly to NCC by post, mail, or fax. If the forms are received directly at the NCC, they are first sent to the nearby AMC where the PV associate gets in touch with the person who has reported the AEs. The PV associate then takes sufficient information from the patient and then after filling the necessary information sends the report back to NCC as ICSRs. These forms are also available in the National Formulary of India, on the website of CDSCO and as hard copies at nearby AMCs where local PV associates help the consumer to fill the reporting form and further send it to NCC for review purpose. These forms are available in two different variants. First one, the red-colored English imprint suspected ADR reporting form for voluntary reporting by HCPS (Version 1.3). Second one, the consumer reporting form in blue color meant for voluntary reporting by Consumers/Patients (Version 1.0). Considering the kind of diversity India has, this form has been drafted in 10 vernacular languages for the ease of reporting by consumers.[31] Both the ADR reporting forms have been made in such a way that everyone can fill up these forms as the particulars in both the forms have been decided after taking into consideration both sets of the society.

Mobile Application

In this technically advanced, modernized world, PvPI launched a mobile application “ADR-PvPI” as a tool for ADR reporting. With the increasing use of smart phones and mobile applications, health-care services can be made to reach quickly to public. The application “ADR-PvPI” is available on Android platform with plans to expand to iOS soon and can be downloaded on any smart phone supporting Android v5.0 or above.[37] Since the inception of this mobile application in September, 2017, awareness of reporting ADRs is increasing among HCPs.[36]

Toll-free Helpline

The ADRs can be reported to NCC-PvPI directly through toll-free number, i.e., 1800-180-3024. Since its initiation on October 11, 2013, the PvPI helpline has quite inflow of ADR reports. Calls are primarily responded to, in English and Hindi during working days, i.e., Monday-Friday (between 9:00 AM and 5:30 PM). This helpline number has been inserted into in-patient and out-patient departmental prescription slips at various hospitals across India. The toll-free number is gaining the momentum for adverse events reporting.[31] The year-wise reporting trends of ADRs received through PvPI helpline signify that this tool is an efficient way to help consumers and HCPs [Figure 5]. The PV officials not only entertain ADRs being reported by the patients but also assist the patients regarding any medication and dosage regimen that is unknown or misleading. With a diversity of callers, this tool for ADR-reporting is one of the easiest ways to verbally communicate with the patients and ask for all the necessary details regarding the AEs. These details are sent to the nearby AMC, and then, PV officials communicate with the patient for acquiring required information and then entered into VigiFlow®.[38]

Figure 5

Adverse events reported through helpline

Voluntary Reporting by Non-Adverse Drug Reaction Monitoring Centre

The non-AMCs are also encouraged by the PvPI to report the adverse events (AE) through following E-mail: icsr.nccpvpi@gmail.com or through post. They may also report the AEs to the nearby AMCs.

Pharmacovigilance-system in Various Selected Countries of the World

As there could be profound risks associated with the use of medicines, hence, drug safety is one of the prime concerns of health-care system around the world. Countries with equipped resources of science and education are already in the process of monitoring medicines for their safety/quality by means of a well-established PV system. The majority of countries, besides being member of the WHO-PIDM, have developed their own framework in terms of resources, tools, and regulations of monitoring drug safety. For harmonization of PV systems, ICH guidelines on Good Pharmacovigilance Practice (GVP) are available on the website of the European Medicines Agency.[39]

ADR reporting is a common practice followed worldwide. One of the things exclusive to a country is the tools that are being provided for the monitoring, assessment, and submission of these ICSRs. Table 3 provides a comparative analysis showcasing different tools for ADR reporting being used in different selected countries around the world. The comparative status of India, United States of America (USA), United Kingdom, Netherlands, South Africa, Italy, Russia, Australia, Switzerland, New Zealand, Malaysia, Japan, Singapore, China, and Germany shows that the most common method of ADR reporting tool is ADR reporting forms, whether they are available to be filled online or available in downloadable formats. India relies on downloadable forms which may then be sent to the nearby AMC or directly to NCC-PvPI. Availability of these forms in nearby AMCs is also an advantage for those patients who cannot download these forms. However, the availability of these ADR reporting forms outside AMCs is also a requirement. With the availability of modern technology, many countries are moving toward utilization of tools such as mobile application and self-assisting toll-free helpline to report ADRs. These tools, if used properly, can provide a method of easy communication between the patient and the concerned PV officials.

Table 3

Adverse drug reaction reporting tools available in selected countries of the world

Country	Regulatory authority	Tools for ADR reporting					References
		Online reporting	PDF/word forms	Mobile application	Helpline	Cards
India	Central Drugs Standard organization	-	✓	✓	]	-	37,23,38
United States of America	United States Food and Drug Administration	✓	✓	-	-	-	40,41
United Kingdom	Medicines and Healthcare Products Regulatory Agency	✓	✓	✓	-	✓	42
Netherlands	Netherlands Pharmacovigilance Centre Lareb	?	-	-	-	-	43
South Africa	Medicines Control Council	-	✓	-	-	-	44
Australia	Therapeutic Goods Administration	✓	✓	-	✓	✓	45,46
Italy	AgenziaItaliana del Farmaco	-	✓	-	-	-	474849
Russia	Federal Services on Surveillance in Healthcare and Social Development Roszdravnadzor	✓	✓	-	-	-	50
Switzerland	Swissmedic	✓	✓	-	-	-	51
New Zealand	New Zealand medicine and medical devices safety authority Medsafe	✓	✓	-	✓	✓	52
Malaysia	National Pharmaceutical Regulatory Agency	✓	✓	-	-	-	53
Japan	PMDA	✓	✓	-	-	-	54
Singapore	Health Science Authority, Singapore	✓	✓	-	✓	-	55
China	Chinese Food and Drug Administration (Presently NMPA) of China	✓	✓	-	-	-	56,57
Germany	Federal Institute for Drug and Medical Devices	✓	✓	✓	-	-	58,59

NMPA=National Medical Products Administration, PMDA=Pharmaceuticals and Medical Devices Agency, ADR=Adverse drug reaction

Future Prospects for Adverse Drug Reactions-Reporting in India

India is one of the largest producers of pharmaceuticals worldwide and the market is expanding with a pace. The PV in India continues to evolve, grow, and improve. These tools such as ADR-reporting forms, PvPI helpline, and the “ADR PvPI” mobile application are now not only limited to the AMCs under PvPI, but as a new initiative, these tools could be displayed by pharmacy stores, private-sector hospitals, and corporate hospitals to enhance the reach to the patients/caregivers. Further, the efforts are being done to make these tools available to every district hospital across the country. Provision of filling the ADR forms downloaded through the website of IPC is a suitable practice as it is less time consuming and more efficient, however, it is still a challenge to provide a convenient e-reporting system in India similar to that available in the USA and other countries. The “ADR PvPI” mobile application and toll-free helpline being the most convenient ways to report ADRs are also the most technically advanced sources available in India; however, efforts are being made to get this mobile app available in official languages other than English to enhance user-acceptance and convenience. The convenience of availability of package inserts (PIs) or patient information leaflets (PILs) to a PV-official must also be encouraged as a huge amount of drugs are marketed in India but the information about the PIs/PILs is not easily available to the PV-officials, and hence, efforts are required from the regulatory authority, to make these PIs/PILs available on the website of CDSCO, India. This will not only help the PV-officials but will encourage consumers to refer these PIs/PILs before taking any medicines. The ambit of PvPI may be expanded to cover veterinary drugs, herbal drugs, and cosmetics based on feasibility. Recently, through S.O. 648 (E) dated February 11, 2020, as notified by the MoHFW, the “devices” definition has been specified, therefore, the scope of determining the safety of medical devices is also expanding.

PvPI has special focus in conducting various kinds of trainings and capacity-building workshops, and SDPs will not only help train HCPs, budding PV professionals and students but help strengthening the consumers' knowledge about ADRs and their reporting system in India.

Conclusion

Public involvement in ADR reporting has been translating into reality which includes all varieties of consumers. The PvPI makes all possible efforts for collection of adverse event data from across the country and disseminates the safety information on medical products through its various resource materials to the stakeholders from time to time. It is evident that the hands of the National Regulatory Authority are being strengthened based on the PvPI outcomes for taking appropriate regulatory interventions. As PV has become an integral part of health-care system, this article has showcased various tools used by selected countries around the world to report ADRs. Authors also identified that, in the domain of drug safety, India stands with the global values. The key aspect is to assimilate various existing programs, recognize and fill the possible gaps, stimulate and educate the stakeholders to facilitate the ADR reporting. Furthermore, a patient-centric approach for continuous monitoring of drug safety profile through PV system is necessary that will help the drug regulators to take evidence-based regulatory decisions and strengthen the health system of country.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.