Health Canada bans import of APIs and Finished Products from 3 sites in India...

Health Canada took action today to stop the import of health products from the following sites in India:

• Apotex Pharmachem India Pvt Ltd (APIPL)
• Apotex Research Private Limited (ARPL)
• IPCA Laboratories

The action applies to finished products from ARPL, as well as active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA.
Health Canada has compiled an initial list of products affected by the Import ban.

CLICK HERE TO VIEW COMPLETE LIST OF PRODUCTS AFFECTED BY IMPORT BAN


The list will be updated periodically.

Certain medically necessary products may be excluded from the action on the condition they are tested by an independent third party before being released for use or sale. Independent testing against specifications will provide confidence that these products meet Canadian quality standards, and will allow consumers to have continued access to medically necessary and safe products.

When data integrity issues were first identified at each of these sites by the U.S. Food and Drug Administration (FDA), Health Canada took action to protect the health and safety of Canadians. There is currently a voluntary quarantine on products from ARPL and IPCA. Products from APIPL have been undergoing additional testing, as required by Health Canada before being allowed on the Canadian market.

Health Canada continues to gather information about the situation at these three sites from trusted regulatory partners, including the FDA. Based on recent information, the Department has significant concerns with the manner in which data are collected and reported, raising serious doubts about the quality and safety of finished products and APIs produced at these sites. Until Health Canada can be satisfied that the production processes used at these three sites meet internationally recognized good manufacturing practices (GMP), it is taking this additional precautionary step to keep these products off the Canadian market.

For more details CLICK HERE

Health Canada requests quarantine of products from IPCA Laboratories following falsification and manipulation of data issues...

Health Canada has taken the precautionary step of asking IPCA Laboratories in India to voluntarily stop shipment of products to Canada based on a review of a recent good manufacturing practices (GMP) inspection report by the U.S. Food and Drug Administration (FDA) where they identified falsification and manipulation of data issues at the company. IPCA has not disputed the FDA findings with Health Canada. The FDA has not issued a recall of any of the affected products.

Health Canada estimates that this affects approximately 21 active pharmaceutical ingredients (APIs). The Department has also asked Canadian companies that import product containing APIs from the IPCA facilities to temporarily quarantine these products.

To date, there has been no indication that the issues identified during the FDA inspection pose a risk to health. Therefore, like the FDA, Health Canada is not requesting a recall of products already on the market. If the situation changes, the Department will take immediate action and inform Canadians.

The information being sought includes any additional testing being done, the medical necessity of the products involved, their market share, and risk assessments. This process will likely take a few weeks to complete given the complexity of efforts. At this time, we do not expect that there will be an immediate impact on the availability of these products. The Department will work with the provinces and territories to monitor the supply situation and, if necessary, develop mitigation strategies.

Health Canada has requested that the voluntary quarantine continue until the Department is satisfied that adequate measures are in place to confirm the quality of the products from these facilities and protect the health and safety of Canadians.

For Detailed Information CLICK HERE