Recall of drug in India and United Kingdom: A comparative review

Recall is the action which is taken to withdraw drug from distribution. If the product is defected in terms of quality, safety, efficacy. Recall can be voluntary or statutory recall. There are different classes of recall based on severity of the recall. In India recall is guided by CDSCO where as in UK done by MHRA (medicines and healthcare products regulatory agency). There are three levels of recall which can be done at consumer, retail, wholesale. Distributors and healthcare professionals play important role in recall of drug. Generally, company initiate the recall with the help of regulatory authorities, distributors and healthcare professionals. Recall is carried out by using different steps with the help of Drug Inspector, marketing company and investigational team. In this review, we are mainly focusing on comparison of recall in regulatory authorities of India and United Kingdom, in terms of level, classes of recall and their similarities and differences.