On World Pharmacovigilance Day, Dr J Vijay Venkatraman, Managing Director & CEO, Oviya MedSafe, takes stock of the country’s pharmacovigilance programme and suggests ways to plug the gaps
Ever since the Pharmacovigilance Programme of India (PvPI) was launched on July 14, 2010, Indian pharmacovigilance has been making continuous and commendable progress. This strong and sustained growth resulted in the Ghaziabad-based Indian Pharmacopoeia Commission (IPC), the National Coordination Centre (NCC) of PvPI, becoming a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services in 2017, among several other achievements. With the success of India’s pharmacovigilance story being now well-accepted in the global arena, this may be the right time for us to exercise prudence and perform a gap analysis to comprehend what more we should do in order for India to be even more productive in pharmacovigilance in the future. It is obvious that such an analysis should focus on the same key stakeholders whose contributions led to the building of the success story in the first place. This article aims to provide a brief overview of the gaps seen in some of the key stakeholders of Indian pharmacovigilance, in the view of the author.

PvPI structure
The basic unit of PvPI is an Adverse Drug Reaction Monitoring Centre (AMC), which refers to medical colleges, hospitals and centres of public health programmes in India, which are authorised to collect suspected ADR reports from healthcare professionals and/or consumers and forward them to the NCC at IPC, Ghaziabad. At the moment, India has more than 250 AMCs directly connected to the NCC. The NCC analyses the received reports and provides recommendations, if any, to the Central Drugs Standard Control Organization (CDSCO) which is India’s National Regulatory Authority. All the reports received by the NCC are submitted to the Uppsala Monitoring Centre in Sweden which is the WHO Collaborating Centre for International Drug Monitoring. In addition, the NCC is well-networked with several national health programmes and government institutions which share ADR information with the NCC. Apart from the above, the NCC also receives reports from the industry since 2015. The process flow of PvPI is illustrated in Figure 1 below.
Healthcare professionals (HCPs) and consumers
HCPs and consumers in India may report suspected ADRs to the PvPI or to the concerned pharmaceutical company. Both the PvPI and the pharma industry have adopted traditional as well as electronic modes for accepting ADR reports. While the report may be processed in a similar manner at both ends, the report sent to the industry would also eventually reach the PvPI via industry reporting. On the other hand, there is no mechanism at present for reports sent to the PvPI directly to be classified and forwarded to the concerned pharma companies.
Although the term HCP may refer to any member of a healthcare delivery team, the reality in India is that most of the healthcare environments are clinician-centric. Therefore, the comfort level a particular clinician has with ADR reporting is the most important determinant of the ‘pharmacovigilance activeness’ of the respective healthcare facility itself. Clinicians enthusiastic about reporting ADRs would implicitly inspire their entire team of HCPs to be ‘pharmacovigilant’ and thereby motivate them to bring any ADR information they receive to the knowledge of the clinicians. A clinician validating an ADR report collected by another member of the HCP team also provides the much critically needed ‘medically confirmed’ status to the case. But, such scenarios are still rare in India which is proven by the fact that the number of ADRs reported in India is still negligible compared to the population of the country. So, why do clinicians not report the ADRs they encounter?
Apart from the usually stated primary reason of lack of time which is obviously a stark reality in India, there are so many other factors that impede doctors from reporting ADRs. First and foremost: a doctor is not able to see the purpose of ADR reporting as they are not made aware of the life cycle an ADR report would go through after it has been received from the doctor. In several one-on-one interactions the author had with renowned clinicians, it transpired that even scientifically inclined doctors were of the opinion that a drug once approved was to be considered always safe and also safe for all patients all the time. The dynamic nature of the benefit-risk profile of a drug is unfortunately not attached due significance in the typical doctor’s cabin where the focus is more on the disease rather than the drug. Whenever the safety profile of a particular drug is discussed, doctors tend to refer to results of clinical trials for the data rather than looking for the more relevant safety information reported in the post-authorisation phase. This could partly be because the former is easily made available to doctors by pharma companies through their medical representatives. Hence, unless a doctor understands the benefit the patient community at large could possibly beget from the ADRs they report, it is unreasonable on the part of other stakeholders to expect doctors to report ADRs especially when they are struggling to find time to provide treatment to all their patients in the first place.
The next key factor could be the fear of potential legal implications which may arise following the reporting of an ADR. While this fear may appear irrational to other stakeholders, a closer look at why doctors feel so reveals that many of them have the apprehension that the mere occurrence of an ADR in a patient under their treatment may get tagged as their ‘medical negligence’ and result in medico-legal suits. It may be too premature and unrealistic to ignore this apprehension in India where consumer courts have penalised doctors in such instances even in the absence of any medication error. Medication errors occur due to medical negligence and may result in adverse outcomes. But, to assume every ADR to be an outcome of a medication error is unscientific. In addition, the risk of physical assault on doctors by the relatives of patients, which has become more pronounced in the recent times, may significantly discourage doctors from opting to report ADRs. Doctors are also wary of being harassed by government authorities if an ADR report they sent in good faith may be turned against them during enquiries in future. More than all these, doctors feel that they may lose their reputation just by being alleged of negligence even if it did not get proved eventually, as it is perceived to increase the risk of inability to continue their practice in the same locality in the long-term. Last but not the least, doctors practising in medical institutions governed by a hierarchical structure may face roadblocks from senior members of their own fraternity and/or from the administrative heads of the concerned institutions that may be averse to reporting ADRs due to a multitude of reasons.
While we still have to go a long way to resolve the above-mentioned issues, it is high time we started addressing them. Promoting healthy interactions between medical societies and the pertinent government authorities would help in quelling the undue fears and apprehensions of the medical community. The distinction between a spontaneously occurring ADR and a medication error should be made clear to all stakeholders. The fact that “even a good drug can do harm” should be understood by doctors, patients, regulators, media and judiciary alike. In a conversation, the author had with a past National President of the Indian Medical Association (IMA), it transpired that the IMA could insist to the government that a doctor should be considered to have done his/her duty if they have reported a spontaneously occurring ADR to the PvPI and should be protected by the government from harassment by authorities or by relatives of patients. Moreover, the report made by the doctor to PvPI should be considered as a legal evidence of the doctor’s proper handling of the situation unless a medication error is proven to have happened. On another note, the inclusion of clinical pharmacists in the healthcare team could drastically improve the reporting rate of ADRs, as they possess the relevant expertise and would have sufficient time to interact with the patients and prepare the reports which could finally be signed off by the doctor.
Coming to consumers, we have two distinct types in India: (i) the patient who consumes medicines prescribed by their doctor and (ii) the self-medicator who consumes medicines at their own discretion. Those patients who properly comply with the prescription usually trust their doctor and therefore we can anticipate that they would also share any suspected adverse drug experience only with their doctor. While such faith in the doctor is good for doctor-patient relationship, this also transitions the responsibility of reporting the ADR to the doctor. Some patients may withhold the suspected ADR information assuming that it may not be related to the doctor’