Bansi l. Bhalodiya, Amit Kumar J. Vyas, Ajay I. Patel, Ashvin V. Dudhrejiya, Ashok B. Patel
Bansi l. Bhalodiya1*, Amit Kumar J. Vyas1, Ajay I. Patel1, Ashvin V. Dudhrejiya1, Ashok B. Patel2
1Department of Quality Assurance, B.K. Mody Government Pharmacy College, Rajkot, India.
2Government Pharmacy College, Gandhinagar, India.
Volume - 13,
Issue - 2,
Year - 2023
The present study describes the pharmaceutical drug recall in different five countries to evaluate the drug recall that occurred in the last three successive years. The different countries have different regulations for drug recall. Drug product recall is an action taken to withdraw or remove a batch or an entire production run of drug product from distribution or use to return them to manufacturer.it is usually done due to deficiency in quality, safety and efficacy. In the USA, guidelines for drugs product recall are described under 21 CFR Parts 7, 107 and 1270. In Australia, guidelines for drugs product recall are described under section 65F of trade practices act 1974. In Canada, it includes under section 25 of Natural Health Products Regulations (NHPR). In India it includes under para 27 and 28 of schedule M. In South Africa SAHPRA (South African Health Products Regulatory Authority) guidelines are responsible for regulations of drug product recall. Majority of drug recalls occur in the United states due to various reasons. In 2020-2022 total 257 drugs were recalled in Last three years. In Canada and Australia 220 and 25 drugs are recalled respectively. India and South Africa have recalled 2 and 21 drugs respectively. By the observation we can conclude that India and South Africa have a smaller number of recalls. In the USFDA number of drug recalls are decreasing due to following up the laws and regulatory.
Cite this article:
Bansi l. Bhalodiya, Amit Kumar J. Vyas, Ajay I. Patel, Ashvin V. Dudhrejiya, Ashok B. Patel. A Study on Pharmaceutical Drug Recall. Asian Journal of Pharmaceutical Research. 2023; 13(2):99-4. doi: 10.52711/2231-5691.2023.00020
Bansi l. Bhalodiya, Amit Kumar J. Vyas, Ajay I. Patel, Ashvin V. Dudhrejiya, Ashok B. Patel. A Study on Pharmaceutical Drug Recall. Asian Journal of Pharmaceutical Research. 2023; 13(2):99-4. doi: 10.52711/2231-5691.2023.00020 Available on: https://www.asianjpr.com/AbstractView.aspx?PID=2023-13-2-6
1. Wikipedia the free encyclopedia “Product recall”, October 2022, https://en.wikipedia.org/wiki/Product_recall
2. Ashok B. Patel, Bhumi K. Jinja, Amit Kumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth, Sunny R. Shah. A Retrospective Study of Warning letters Issued by US FDA Over 2019-2021. Asian Journal of Pharmaceutical Research 2022; 12(4):295-1.
3. Luxminarayan L, Neha S, Amit V, et al. Asian journal of pharmaceutical research and development. Asian J Pharm Res Dev 2017; 5: 1–8.
4. Wikipedia, October 2022, en.wikipedia.org/wiki/Food_and_Drug_Administration
5. "US Food and Drugs Administration (USFDA). As amended through P.L. 114-255, Enacted December 13, 2016. Federal Food, Drug, and Cosmetic Act (FD&C Act). United States Code, Title 21. 2016; October 2022, https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/federalfooddrugan dcosmeticactfdcact/defaul t.html
6. Sovasia N, Thacker S, Patel T. “Quality management of complaints and recalls of pharmaceuticals as per global GMPs”, Bihani S.D. College of Technical Education, Institute of Pharmaceutical Science & Drug Research, Sri Ganganagar, Rajasthan, India, Pharmacy Infopedia, October 2022,doi: 10.4103/2230-973X.147222 available on http://www.pharmatutor.org/articles/qualitymanagement-of-complaints-andrecall-of-pharmaceuticals-asper-global-gm
7. "Safety Recall Definitions" US Food and Drug Administration, October 2022, https://www.fda.gov/Safety/Recalls/ucm165546.html
8. Ashok B. Patel, Ashish H. Asnani, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Arvind N. Lumbhani. A Brief Review on Genotoxic impurities in Pharmaceuticals. Asian Journal of Pharmaceutical Research. 2021; 11(3):187-3.
10. Soumesh Kumar Tripathy. Pharmaceutical Validation: A Quality Maintaining Tool for Pharmaceutical Industry. Asian J. Pharm. Res. 2020; 10(4):307-311.
11. Kamrun Nahar, Tanveer A. Khan, Md Kamal Hossain. Childhood Obesity Status in Australia: A Recent Perspective. Research J. Pharm. and Tech. 2017; 10(8): 2727-2734.
13. Abhinaya N., Girish Thunga., Muddukrishna B S., Raveendra Pai., Ravindra Shenoy U., Sohil Khan., Girish Pai K.. A Research on Effective Management of Manufacturing Defects to Avoid Product Recalls: A Challenge to Pharmaceutical Industry. Research J. Pharm. and Tech. 2019; 12(12): 6124-6132.
14. Sandeep D S, Ashwin Raj K M, Anoop Narayanan V, Akhilesh Dubey, Jobin Jose. Regulatory Approval Process for Drugs in Canada- A Challenging Task. Research J. Pharm. and Tech. 2019; 12(7):3206-3210.
15. “The Drugs & Cosmetics Act 1940 & Rules 1945”, October 2022.
16. “The WHO TRS for GMP Guidelines”, October 2022.
17. Work Shop on Recall & Rapid Alert System, held at New Delhi Office from 27 th to 30 th August 2012 organized by CDSCO in collaboration with WHO.
18. USFDA documents on recall.
19. “The Guidelines on Recall & Rapid Alert System for Drugs including Biologicals and Vaccines. 43rd DCC sub-committee Guidelines”, October 2022.
20. P. Sujani, M. Veera Babu, P. Premitha Rajya Lakshmi, B. Swathi Chandra Sekhar. Evaluation of Cosmetics: A Review. Res. J. Pharma. Dosage Forms and Tech.2021;13(1):76-81.
21. A Review: Indian Pharmaceutical Education and its Regulatory Authorities. S. C. Shivhare, K.G. Malviya, Preeti Srivastav, U.D. Shivhare, Atneriya U.K. Research J. Pharma. Dosage Forms and Tech. 2012; 4(1):14-18.
22. “Circular 9/98 of the Medicines Control Council”, October 2022.
23. “Uniform Recall Procedure for the Therapeutic Goods”, October 2022.
24. PIC/S Procedure for Handling Rapid Alerts and Recalls arising from quality defects, Procedure PI 010-2.
25. Sara Jabeen, Sridhar S, Balamuralidhara V. Drug Recall Procedure in ASEAN Countries. Research J. Pharm. and Tech. 2019; 12(12): 6041-6048.
26. Kalpana Kamnoore, M P Venkatesh, Balamuralidhara V, T M Pramod Kumar. Regulatory requirements for conducting Clinical Trials in India. Research J. Pharm. and Tech 2020; 13(3):1517-1522.