Contingent analysis and evaluation of pharmaceutical product recall procedure of USA and India

Author : Pasumarthy N. V. Gopal, Pichukala Anusha, T. Lakshmi, M. V. Nagabhushanam, D. Nagarjuna Reddy

In this developed era with escalating health complications there are number of new drugs breaching the market. Post market clinical trials revealed that many drugs available in the market cause adverse effects. Regulatory authorities recall those defective drugs in the market based on the guidelines framed by the regulatory authorities of respective countries. In USA, guidelines for pharmaceutical product recall are described under 21 CFR Parts 7, 107 and 1270. In India, references for pharmaceutical product recalls, complaint and adverse reactions are mentioned in Para 27, 28 of Schedule M and conditions of license for defective product recall in Rule 74(j) and Rule 78(i) and banned drugs under 26A of the Drugs and Cosmetics Act, 1940 and Rules. In this paper we discussed about recall procedure of pharmaceutical products and comparative study in USA and India.

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