Impact of USFDA Warning Letters on Economic Growth of Indian Pharmaceutical Industry

Abstract

The common compliance issues to USFDA guidelines for pharmaceutical industries around the world include inadequate or poor quality systems, lack of data integrity, inadequate validations and product contamination. Such significant violations result in issuance of WLs from the USFDA. WLs, in turn, restrict the further manufacturing of drugs, resulting in financial losses. WLs also have an implication on the credibility of the concerned pharmaceutical industry. These tangible and intangible effects are expected to have an impact the economic status of the industry. India is the world's largest provider of medicines to US. As a case study, the overall economic impact of the issued WLs on different Indian pharmaceutical industries for period of 20102021 is reported. The study concludes that in spite of issuance of 128 WLs in the said period, the overall drug export from the country is not much affected as no conclusive impact could be observed on the economic growth of Indian pharmaceutical industry. This is attributed to the compensation by the continued exports from the pharmaceutical industries to which WLs were not issued.