Abstract

Background: The dynamic pharmaceutical industry is driven by regulatory authorities viz. Central Drug Standard Control Organization (CDSCO) for India, European Agency for the Evaluation of Medicinal Products (EMEA) for Europe, Therapeutic Products Directorate (TPD) for Canada, Medicines and Healthcare Products Regulatory Agency (MHRA) for UK, Therapeutic Goods Administration (TGA) for Australia, Medicines Control Council (MCC); however the most prominent among the regulatory agency is US Food and Drug Administration (FDA).

Discussion: The FDA’s effort to protect consumers from health fraud in the form of issuing import alerts or warning letters or 483 are praiseworthy. Because it promotes compliance and helps to ensure quality, safety and efficacy of drugs. In general notifying to an organization with import alerts or warning letters or 483 may not be the most welcomed news, however it should be viewed as a valuable tool. With the awareness of auditing and compliance, now pharmaceuticals are more conscious and thoughtful for regulatory auditing and compliance. Moreover, this kind of mind set, preparedness, and seriousness for audit is helping to make practices and processes more rigorous, and in a broader sense, ultimately human beings are getting benefits of receiving quality embedded drugs. With this article, post-mortem of FDA’s currently issued some of the important warning letters for noted Indian pharmaceutical firms has been made, reasons have been segmented and some of the suggestions have also been sighted.

Conclusion: The inference of this article can act as a reference for pharmaceutical organisation those who are becoming ready for upcoming audits. Preparedness and seriousness for audit will help to make pharmaceutical industry’s practices and processes more rigorous, and ultimately with these, human beings are getting benefits of receiving quality embedded drugs.

Keywords: Regulatory audit, regulatory authorities, warning letters, compliance, 483s.

Graphical Abstract