A review of CDSCO’s guidelines on Recall and rapid Alert system for Drugs

  • Shrikanth Pulparambil Student
  • G Siddappa Shanthakumar


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.

Keywords: Recall, Mock recall, Rapid alert system, DCGI, CDSCO, Pharmacovigilance


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How to Cite
Pulparambil, S., and G. S. Shanthakumar. “A Review of CDSCO’s Guidelines on Recall and Rapid Alert System for Drugs”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 3, Sept. 2020, pp. 29-35, doi:10.22270/ijdra.v8i3.405.