ISSN : 2663-2187

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

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Hanumant Gambhire, Sachin Kumar Singh, Monica Gulati
ยป doi: 10.48047/AFJBS.6.12.2024.4709-4724

Abstract

The drug companies which sell their medicines in the United States are expected to adhere to the regulations which are entailed by the FDA. The manufacturing units which are engaged in the supply of drugs are frequently inspected by the FDA. Common issues for pharmaceutical industries around the world (including US and India) include inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various processes used in manufacturing or testing, and product contamination. In any region, some drug manufacturers meet US requirements, while others do not. When USFDA determine that there are significant violations at pharmaceutical industries, USFDA take appropriate action to protect the public health through issuing waring letters(WLs) and enacting import alerts to the drugs manufacturing units resulting the financial loss. The WLs not only impacts particular industry but it has direct implications on society where the lot of human being earnings are directly or indirectly depends on the pharmaceutical industries. The Indian pharma firms need to persistently evolve with the variations in the global regulatory compliances and accordingly adjust cost and resources to adhere to those standards. The overall economical impact of issued WLs on the pharmaceutical industries are to be studded in the article.

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