Drug Recalls: Trend analysis of Recalls by Indian Pharmaceutical Industry during the period 2013-2023

  • Nikita Varshney University
  • Vijay Bhalla Principal and Professor, SGT University, Gurugram
  • Manish Gupta Professor, SGT College of Pharmacy, SGT University, Gurugram
DOI https://doi.org/10.22270/ijdra.v12i1.645

Abstract

With the advanced technologies, increasing complexities of the manufacturing processes, more stringent inspections, and dynamic regulatory environment under which manufacturers work, there are high possibilities that a pharmaceutical firm will undergo a recall of one of its products. A recall can impact a company in product exposure, sales, manufacturing costs, and patients trust. The study presented here explored the drug recalls made by Indian Pharmaceutical Industry during the period of 2013 – 2023.  There is an increasing trend in number of recalls post 2017 which could be due to the new regulations and, scientific discoveries. The major reasons for recalls primarily included cGMP deviations, failure to comply with approved specification, labeling mix ups. The study enlists the expectations of US FDA from Indian Pharmaceutical sector. This will help Indian pharmaceutical manufacturers to adopt the strategies to minimize drug recalls.

Keywords: Drug Recall, Pharmaceutical, Indian Pharmaceutical Industry, Risk based classification, FDA (Food and Drug Administration)

Downloads

Download data is not yet available.

References

1. FDA Recalls Background and Definitions [Internet]. US FDA; 2014 [cited 2023 Nov. 25]. Available from:
https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions
2. FDA Drug Recalls [Internet]. US FDA; 2024 [cited 2024 Jan. 09]. Available from:
https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls
3. FDA’s Role in Drug Recalls [Internet]. US FDA; 2023 [cited 2023 Dec. 02]. Available from:
https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls
4. FDA Compliance Dashboard [Internet]. US FDA; 2021 [cited 2022 July 07]. Available from:
https://datadashboard.fda.gov/ora/cd/recalls.htm
5. Enforcement Report, Recall letters [Internet]. US FDA; 2024 [cited 2024 Jan 05]. Available from:
https://www.accessdata.fda.gov/scripts/ires/
6. Nagaich U, Sadhna D. Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history. Int J Pharm Investig [Internet]. 2015 Jan-Mar [cited on 2022 Aug 7];5(1):13-9. Available from National Library of Medicine. doi: 10.4103/2230-973X.147222.
Statistics
139 Views | 192 Downloads
How to Cite
1.
Varshney N, Bhalla V, Gupta M. Drug Recalls: Trend analysis of Recalls by Indian Pharmaceutical Industry during the period 2013-2023. Int J Drug Reg Affairs [Internet]. 2024Mar.15 [cited 2025Jan.12];12(1):20-3. Available from: https://www.ijdra.com/index.php/journal/article/view/645
Issue
Vol 12 No 1 (2024): VOLUME 12, ISSUE 1, 2024
Section
Review
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.

I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.

Download link for COPYRIGHT FORM