IGMPI India

Health Canada has decided to stop importing and distribution of products manufactured by Dr Reddy’s Labs (DRL) and IPCA Labs at the Srikakulam and Pithampur facilities, respectively.

The action has been taken as a precautionary measure to safeguard from potential risks on account of concerns raised over the reliability of the laboratory data generated at the sites.  Since no identified risks to health have been observed till date hence no recall of any of the product has been made by Health Canada. Analysts believe that this action will have less impact on the revenue of IPCA and Dr Reddy’s Laboratories as they do not derive their significant revenues from these facilities.

Only a few months back, Health Canada, took action against IPCA Lab raising concerns over reliability of data on "safety and quality" issues and issued an import ban on the products manufactured at one of its facilities. Health Canada is likely to rely on USFDA’s inspection reports for their future course of action.

Dr Reddy’s Lab and IPCA labs were already under USFDA scanner. Six serious deviations were observed by USFDA at the IPCA’s Ratlam Plant in August 2012 and they also issued form 483 to IPCA’s plant at Pithampur and Indore during plant visits. Moreover Dr Reddy’s Laboratories also received nine inspectional observations in the form 483 by US FDA at its Active Pharmaceutical Ingredients manufacturing plant in Srikakulam district, Andhra Pradesh.