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).