“India has good planning but faulty implementation.” This analysis by Dr Surinder Singh, Director in charge, National Institute of Biologicals summed up the uphill task before India can claim to have a robust pharmacovigilance (PV) system. Therefore two workshops, the first in Bengaluru followed by a second in Mumbai within a week, by the Partnership for Safe Medicines (PSM) India Initiative, are a welcome move to get together the different links of the PV system Both workshops served as platforms to discuss near-term solutions that help train health care professionals, patients, consumer groups and other stakeholders throughout India.
The key points that were discussed ranged from the regulatory (role of the central government in developing policies on patient safety and quality health, the role of the state government on strengthening the drug regulatory mechanism at the ground level) to the clinical (practitioners deliberated on the impact of non-adherence to medication compliance). Integration of technology measures in monitoring of adverse drug reactions (ADRs)) was followed by representatives from NGOs like RARE Consumer Organisation from Orissa on community engagement and communication on PV and specifically India’s PV programme, the Pharmacovigilance Programme of India (PvPI).
Dr Surinder Singh’s comment set the tone of the day in the inaugural session which had regulators like C P Singh, IAS, Chairman, NPPA, Dr V G Somani, Joint Drugs Controller India, and Mahesh Zagade, FDA Commissioner, Govt. of Maharashtra spelling out their initiatives on the PV front as well as admitting to gaps which need to to be filled. The workshop was hailed by all speakers as an opportunity to come up with workable action points which could be built into the system. Bejon Misra, trustee of the Consumer Online Foundation and founder of PSM India Initiative indicated that these points would be summarised and presented as a proposal for actions.
For instance, the private healthcare provider’s perspective came from Dr Pervez Ahmed, Vice Chairman, PSM India Initiative who opined, “We have to not reform but transform the system.” He is also lead director and vice chairman, Saket City Hospital, Delhi and his views possibly reflected that of many private healthcare providers when he recommended engaging medical schools to influence the prescribing habits of doctors. The system has to be made more patient centric by re-designing the training schedule and curriculum. He recalled his own experience of practice in the US where the system has in-built triggers, for instance, anyone over 65 years on more that nine medicines immediately sets off an alert that there is some problem of quality of care. He hopes that such triggers and alerts can be built into our county’s PV system as well.
Dr V Kalaiselvan, Senior Scientific Officer, Indian Pharmacopoeia Commission, Ghaziabad gave an update on the role of the National Coordination Committee in PvPl while Dr Urmila Thatte, Prof and Head Dept of Clinical Pharmacology, Seth G S Medical College & KEM spoke on the role of ADR monitoring centres. She emphasised that outreach to clinicians is very important and highlighted that more work needs to be done to improve reporting from centres as its important to have Indian data. Her sense was that unless there was pressure from patients, reporting rates would not improve as practising doctors would then be forced to report ADRs.
Dr Ketan Parikh, paediatric surgery consultant, Indian Medical Association, expressed his previous reservations about the PV system and the difficulties of clinicians like him incorporating ADR reporting into their daily practice. Patients need to be alerted that there could be ADRs to any medication so that they do not go on the offensive blaming either the doctor for faulty diagnosis or prescription, the drug company for faulty medicines. This attitude puts the doctor on the offensive who blames the patient for not following the dosage regimen. The drug company could go on the offensive but also highlighted the impact of non-adherence to medication compliance. He resolved to listen to clinical pharmacologists like Dr Thatte more often.
Given the many challenges, hope came from the integration of technology into the PV system. Dr Praful R Naik, Executive Director & Chief Scientific Officer, Bilcare gave details of a collaborative project with the CSIR. Field validation studies rolled on from September and the hope is that Bilcare’s non-clonable tags integrated into medicine strips would work as both anti-counterfeiting devices as well as improving patient compliance and ADR reporting. (More details in Express Pharma report: ‘Bilcare starts field validation studies of its nonClonableID technology’; http://bit.ly/1al0J6L)
Actionable suggestions
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Some of the suggestions are already on the agenda. For instance, Dr Singh said that they will be taking the “battle into the clinicians’ court” through CMEs (six planned for this year itself) and such PV workshops (two per month). And since the sensitisation has to start from the top, Dr Singh indicated that Dr Shakti Gupta, medical superintendent and HOD, hospital administration, AIIMS, has been approached to speak to this community of medical superintendents. There are plans that the Drug Controller General (India) will involve his army of lieutenants, i.e. the CDSCO’s drug inspectors to visit ADR centers where there is zero reporting of ADRs but Dr Singh gave an assurance that ADR reporting will be non-punitive.
For once, funds are not an issue. Dr Singh indicated that Rs 100 crores has been set aside for PvPI in the current Five Year Plan, with Rs 10 crores allocated for the current year. The finds are being deployed to set up the basic infrastructure like the ADR reporting cells, etc. With both the funding and the policy aspects in place, lets hope that the PvPI finds wider acceptance. Organisations like PSM India and other consumer activist groups need to keep up the pressure to ensure that these activities pick up momentum and do not fizzle out.
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