Pharmacovigilance regulations in India: A Step forward

Abstract

Robust regulatory arrangements provide the foundation for a national method of medicine safety, and for public confidence in medicines. This article focuses on the need to sharpen the regulatory requirements for pharmacovigilance in India. To be effective the remit of drug regulatory authorities needs to go further than the approval of new medicines, to encompass a wider range of issues related to the safety of medicines. In order to achieve their respective objectives pharmacovigilance programs and drug regulatory authorities must be mutually supporting. On one hand, pharmacovigilance programs need to maintain strong links with the drug regulatory authorities to ensure that the latter are well briefed on safety issues in everyday clinical practice, whether these issues are relevant to future regulatory action or concerns that emerge in the public domain. On the other, regulators need to understand the pivotal role that pharmacovigilance plays in ensuring the ongoing safety of medicinal products. Despite global focus on the Development Safety Update Report, Indian regulators are not yet insistent on real-time update of a drug’s cumulative safety profile. Hence, the present article concludes with a strong urge to postulate regulations that create a comprehensive medicine safety system through careful strategic planning that envelope all aspects of pharmacovigilance.

Keywords::

• National pharmacovigilance program
• clinical trial safety
• ADR monitoring centers
• proactive pharmacovigilance