Canada Hits Dr. Reddy’s With Import Ban
January 1st, 2015 // 5:06 pm @ jmpickett
Indian drug manufacturers are now coming under tough scrutiny of Canadian drug regulators. Health Canada this week stated that Canadian importers of drugs are putting an import ban on drug products from Dr. Reddy’s Laboratories, as well as IPCA Laboratories.
Health Canada stated that Canadian drug importers are quarantining health care products from these two companies, due to concerns about data integrity. The Canadian regulator stated that there are concerns being raised about the reliability of lab data that is coming from several sites of these firms.
This action applies to APIs that come from Dr Reddy’s labs and also finished drug products. Only a few months ago, Health Canada also took actions against IPCA Lab, which raised worries about the reliability of their data pertaining to safety and quality issues.
The Srikakulam plant at Dr Reddy’s and the Pithampur facility for IPCA lab have both been criticized by FDA in recent months. Both of them got a 483 in 2014 that focused on nine serious observations.
In July 2014, IPCA stopped sending out drug shipments and APIs from its facility in Ratlam India after an FDA audit raised serious quality concerns on an FDA 483. It added that the decision would have an effect upon the formulations that it exports to the US.
It remains to be seen how much this ban will affect the bottom line for Dr Reddy. Much depends upon how quickly the company is able to fix its quality problems.
