2nd Annual Conference of Society of Pharmacovigilance, India - A Report

The Second National Conference of Society of Pharmacovigilance, India was held under the presidentship of Prof. K. C. Singhal at Ballabhbhai Patel Chest Institute (VPCI), University of Delhi, Delhi during 1-2 March 2003. The organizing secretary was Dr. Arunabh Ray, Professor and Chairman, Department of Pharmacology, Patel Chest Institute, Delhi.

 
In 1998, an idea was generated during the International Workshop on Adverse Drug Reaction Monitoring to establish Pharmacovigilance as a distinct and influential clinical discipline in India. To give shape to this idea, a meeting of interested scientists took place at Lucknow at the time of the annual conference of Indian Pharmacological Society. Some decisions were taken at the meeting and as a follow up, action application was submitted under the Societies Registration Act XXI of 1860. Prof. K. C. Singhal of Aligarh drafted the Memorandum of Association for the Society of Pharmacovigilance, India (SOPI). The first meeting of the society was held in Agra. At present, SOPI is the only single national society in the entire world and is associated with International Society of Pharmacovigilance (Earlier European Society for Pharmacovigilance). In addition to the office bearers and executive members, the society is a component of 160 life-members.
 
In spite of the fact that Pharmacovigilance is a new discipline in India, around 62 participants registered themselves in the 2nd Annual Conference as delegates including 4 foreign delegates.  Inaugural Session was started with “Welcome Address” by Dr. V. K. Vijayan (Director, VPCI) followed by Presidential Address by Prof. K. C. Singhal. The chief guest Prof. Ralph Edwards (Director, WHO Collaborating Centre for ADR Monitoring, Uppsala, Sweden) delivered the inaugural address, while Prof. P. N. Srivastava (Chairman, Governing Body, VPCI) released the souvenir. Keynote address was given by Prof. S. D. Seth (ICMR Chair, Clinical Pharmacology) and at the end; Prof. A. Ray presented the Vote of Thanks.
 
President of the Society, Prof. K. C. Singhal in his presidential address emphasized on the need of concerted efforts for organized activities of Pharmacovigilance which is need of the day. Monitoring is needed for adverse drug reactions (ADR), medical devices, drug abuse, counterfeit drugs and for medical errors. He informed that 85,000 pharmaceutical formulations in India poses even greater problem in monitoring ADR. Large number of drugs available in the market is unethical and is being promoted by industry and drug control regulators. Prescription drugs are available without prescription, responsible for drug-induced reactions. He emphasized the need to dissociate the hazards caused from the abuse factors from the medical negligence and to revamp laws and judicial panel for alleged negligence against physicians. Prof. S. D. Seth emphasized that ADR Monitoring Center and Poison Centres should jointly be established in every medical institution and the findings and observations be published in newsletters and journals. Prof. Edwards emphasized the need for rational drug therapy, approaching poor population for providing effective medical care, conducting research and finding usefulness of Traditional and Complementary Medicines in comparison with drugs of modern systems of medicine.
 
The deliberations of the conference were held in nine sessions. It brought together officials from national governments and International organizations like WHO Collaborating Centre for ADR Monitoring, academia, research institutes, public health and private pharmaceutical industries and others to discuss possible mechanisms for global cooperation in raising the importance of Pharmacovigilance, and increasing the transparency of such efforts, as well as fulfilling global obligations to facilitate technology transfer. During the meeting, possible legal frameworks to enhancing global cooperation on ADR Monitoring were discussed. Overall, the deliberations aroused interest in participants and very useful discussions took place especially with experts from WHO. The discussions were held in a friendly and healthy environment.
 
The John Autian Oration was delivered by Prof. Ralph Edwards. This oration was established after the name of Prof. John Autian, Dean Emeritus and Former Vice Chancellor, University of Tennessee at Memphis.
 
Pharmacovigilance is a new and emerging discipline. It is relatively more new to India. Limited number of physicians, pharmacists and faculty members in medical colleges has awareness about the methodologies and activities in the field of Pharmacovigilance. Pharmacovigilance activities should be carried out in coordinated manner under the auspices of Government agencies, apex hospitals and Society of Pharmacovigilance, India. Collaboration should be sought from WHO Centre for Adverse Drug Reaction Monitoring Uppsala, Sweden at levels other than National Centres to facilitate ADR monitoring and reporting. ADR Monitoring and other aspects of Pharmacovigilance should form a part of curriculum for undergraduate medical (MBBS.), Pharmacy (B. Pharma and M. Pharma) and postgraduate medical students (MD/MS).
 
Regional Centres should be established for Pharmacovigilance activities. The main activities of these centres should be ADR Monitoring, Error Monitoring, Poison Information and to promote Rational Drug Therapy. General practitioners and specialists in private practice be involved in Pharmacovigilance activities. Recently, Central Drugs Standard Control Organization (CDSCO), an establishment of Directorate General of Health Services, Ministry of Health & Family Welfare, has initiated a Pharmacovigilance project across the country. This project will envisage setting-up peripheral, regional and zonal Pharmacovigilance centers for spontaneous as well as drug specific adverse drug event monitoring and causality analysis.
 
Overall the programme was highly educative and useful in updating knowledge of pharmacologist, pharmacists, General / Specialist practitioners, Academicians, medical teachers and consultants. It was very well organized. All delegates including foreign one were very happy and satisfied with all scientific sessions.
 
Following major decisions were taken during General Body Meetings on 1.3.2003:
1. The house approved the previous minutes of the 1st Annual Meeting.
2. The house approved the Treasurer and Secretary’s Report.
3. The house elected following members as the office bearers' of the society: Prof. K. C. Singhal (Aligarh) – President; Prof. N. S. Parmar (Gandhinagar) & Prof. A. Ray (Delhi) - Vice-Presidents; Dr. Sandeep Agarwal (Agra) - Gen. Secretary; Dr. Pipasha Biswas (UK) - Secretary International Affairs; Dr. Govind Mohan (Agra) – Treasurer; Dr. Syed Ziaur Rahman (Aligarh) – Editor; Dr. A. K. Kela (New Delhi) - Member, EC; Dr. Geeta Sharma (Amritsar) - Member, EC; Dr. Barna Ganguly (Karamsad) - Member, EC; Dr. Anil Kumar (Rohtak) - Member, EC.
4. The third annual conference of SOPI will be held at Agra followed by the 26th National Centres Annual Meeting of WHO Collaborating Centres, Uppsala, Sweden (Delhi, India, 8-10 December 2003).