A review of CDSCO’s guidelines on Recall and rapid Alert system for Drugs
The Central Drugs Standard Control Organization (CDSCO) ensures that all the pharmaceutical products are subjected to rigorous testing for its safety and efficacy before it is marketed. As per WHO, the existence of false claim medications, spurious, false labeled products that are freely produced and forged, packed with false labeling or misbranded is a trend growing worldwide. Drug recalls are carried out on severely defective drug products which can cause health risks to the patients by voluntarily by manufacturers or by the mandate of CDSCO. Recall guidelines are well established in India with a focus on recall classification, recall assessment and management, steps taken to increase rapport between manufacturer and CDSCO regarding recalls. Timelines to carry out any class of recalls are specified in their guidelines. This article aims at reviewing the CDSCO’s Guidelines on Recall and Rapid Alert System for Drugs including recall classification, procedure, and levels of recall, recall evaluation system, timelines, and follow up actions.
2. Sadhna D, Nagaich U. Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history. International Journal of Pharmaceutical Investigation [Internet]. 2015 [cited 2020 Jul 08]; 5(1):13. Available from:
3. Shewale S, Chavan M, Parekh S. Pharmaceutical Product Recall: Lesson Learned. INTERNATIONAL PHARMACEUTICAL INDUSTRY [Internet]. 2014 [cited 2020 Jul 08]; 6(1):5. Available from:
4. Eissa M. Drug Recall Monitoring and Trend Analysis: A Multidimensional Study. Global Journal on Quality and Safety in Healthcare [Internet]. 2020 [cited 2020 Jul 08]; 2(2):1. Available from:
5. DerSarkissian C. Drug Recalls: Why They Happen and What You Should Do [Internet]. WebMD; 2020 [cited 2020 Jul 08]. Available from:
6. Llamas M. Drug Recall Guide | What to Do If Your Drug Is Recalled [Internet]. Drugwatch.com; 2020 [cited 2020 Jul 08]. Available from:
7. Choudhary A. Product Recall Procedure in Pharmaceuticals [Internet]. pharmaguideline.com; 2018 [cited 2020 Jul 08]. Available from:
8. Venkatesh P, Bigoniya D, Pramod T. Pharmaceutical Product Recall Procedures in India, South Africa and China. International Journal of Pharmaceutical Sciences Review and Research [Internet]. 2017 [cited 2020 Jul 13]; 46(2). Available from:
9. Pasumarthy NVG, Pichukala A, Lakshmi T, Nagabhushanam MV, Reddy DN. Contingent analysis and evaluation of pharmaceutical product recall procedure of USA and India. World J Pharm Sci. 2014; 2(12): 1728-35.
10. Goguen D. Difference Between FDA Class I, II, and III Recalls [Internet]. alllaw.com; 2020 [cited 2020 Jul 13]. Available from:
11. Dharmesh B, Venkatesh M, Pramod T. Pharmaceutical Product Recall in USA and EU: Comparative analysis. International Journal of Pharmaceutical and Clinical Research 2018 [Internet]. Impactfacor; 2018 [cited 2020 Jul 13]; 10(4). Available from:
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