Since India is the fourth largest producer of pharmaceuticals in the world and also emerging as a clinical trials hub, there are many new drugs being introduced in the market. These drugs, however, do not guarantee patients’ safety. There, hence, is an immense need to improve pharmacovigilance system in India.

Sadly though, pharmacovigilance systems are not cash rich as it is being funded only by the World Bank. There is no funding at all from the budget of the health ministry. Moreover, there is hardly any sharing of the ADRs between health professionals and the regulatory bodies.

Even more dangerous is that the hospitals carrying out some work on pharmacovigilance as part of postgraduate theses is hardly shared with regulatory authorities or other peer groups in the country. Nor do they inform the pharmaceutical manufacturer regarding ADRs.

Furthermore, there is total lack of awareness about ADRs among general public. Even if few people know about it, their complaints are side-stepped by the regulatory authorities.

If healthcare professionals, regulatory authorities, pharmaceutical companies and consumers are to be benefited by the intake new drugs in the market, there has to be a pharmacovigilance system in order.

Having considered the problems and challenges facing the development of a robust pharmacovigilance system for India, I would like to make the following proposals -

• Build robust pharmacovigilance system  
• Make pharmacovigilance reporting mandatory
• Introduce pharmacovigilance inspections
• Strengthen DCGI with trained scientific and medical assessors
• Create a central database for all protocols and clinical trials
• Educate and train medical students, pharmacists and nurses
• Collaborate pharmacovigilance organisations in enhancing drug safety
• Build pharmacovigilance network
• Interact with IT sector in building a robust pharmacovigilance system