IGMPI India



Health Canada lifts its ban from two Apotex facilities in India

Health Canada has lifted its ban from Apotex two Indian facilities. Canada’s drug regulator reinspected the two plants in June and determined “satisfactory progress” had been made to address its concerns about the company’s data integrity. Health Canada had banned the product of the Apotex two Banglore facilities from September 2014. During inspection the inspector found that the staff had manipulated data and were retesting drug samples until they got favourable results.

Health Canada lifted the ban under new conditions that the staff at Apotex’s Canadian labs must retest all of the products from the two Indian plants before they can be released to market: a safeguard the company has said it already employed before the ban.The company must also report all “deficient testing results” for products originating from the Indian plants so that Health Canada can monitor the firm’s internal investigations into the suspect drugs.

The government also said in its statement that “Health Canada will not hesitate to take immediate action at any time should a risk to the health and safety of Canadians be identified”.

Products from the two Apotex Indian facilities are still banned from the United States.