Pharmacovigilance is still in its infancy in India and there is a lack of awareness and knowledge about this discipline among the people in the country. While major advancements in the discipline of pharmacovigilance have taken place in the western countries, not much has been achieved in India.
VK Matta, director of Symogen India, said, "India rates below one per cent in pharmacovigilance against the world average of five per cent. It is a well-known fact that hardly any pharmacovigilance activities take place in India. There are several reasons and we believe that the basic reasons is the ignorance about the subject and the fear of doctors not prescribing the product if the patient reports too many side effects".
Symogen is a UK-based company with expertise in all aspects of pharmacovigilance and pharmacoepidemiology. It will start a highly intensive and focused course on pharmacovigilance and pharmacoepidemiology from September 2007.
"No medicine is without side effects, but recognizing the adverse effects and pro-actively conducting risk-benefit analysis throughout the life cycle of the product can reassure public and regulatory authorities confidence on the product and also the company", he further added.
However, with good training and understanding of pharmacovigilance, it is possible to keep even the riskier products on the markets by undertaking continuous safety evaluation and signal detection and implementing product risk management plans throughout the life cycle of the product. But most important is creating an awareness and training not only to physicians and other healthcare professionals, pharmacists and nurses, but also to the people in the country to report any adverse drug reactions to the manufacturers and regulatory authority.
The physicians on the other hand should be encouraged by the Ministry of Health, Medical Council of India and other bodies to report any adverse events promptly by filling in a simple questionnaire and submitting it to the Drug Controller General of India (DCGI) office. The Department of Health and the Health Ministry should also be supportive of this training and in creating awareness and allocating resources to make this important venture successful.
However, with more and more clinical trials and other clinical research activities being conducted in India, there is an immense need to understand the importance of pharmacovigilance and how it impacts the life cycle of the product, so as to integrate good pharmacovigilance practices in the processes and procedures to help ensure regulatory compliance and enhance the quality of clinical trials safety and post-marketing pharmacovigilance.