Last month, Canada’s regulatory body took action to stop the import of finished formulation drugs and APIs manufactured at two Bangalore facilities run by Apotex, and a facility run by IPCA Laboratories, after data integrity issues and GMP violations were identified by the US Food and Drug Administration (FDA) earlier this year.
Two weeks later and Health Canada is allowing 42 drugs it says are “medically necessary products” to be exempt from the ban, issuing new licenses to companies which sell the products made at these facilities in Canada providing they undergo independent testing.
“The licences of companies that import products from these three facilities have all been amended with terms and conditions to require independent third party testing against the approved Canadian specifications prior to release of any medically necessary products to the Canadian market,” Health Canada said in a statement.
So far six products marketed by Actavis and Teva have been tested and are ready to be released. Other companies affected include AstraZeneca, Jubilant, Mylan, Ranbaxy, Sandoz and Sanis Health.
Products not deemed medically necessary will continue to be banned from import or released in the country “until Health Canada is satisfied that the data integrity issues at the plants have been addressed.”
Apotex’s API facility is also banned from exporting product into the US following an FDA import alert in April, and in July the facility received a Warning Letter after Apotex failed to adequately respond to a Form 483. Later that month, IPCA voluntarily suspended shipments of APIs to the US from its Ratlam plant in the Madhya Pradesh region of India after receiving a 483.
Helath Canada’s policy is aimed at ensuring there are no shortages of critical drugs, as was the case when quality deficiencies at Boehringer Ingelheim’s now defunct contract manufacturing offshoot, Ben Venue Laboratories, led to regulatory enforcement and the temporary shutdown of production.
The cancer drug Doxil (doxorubicin HCl) was one of the drugs affected, with Janssen’s sales falling by almost 90% at the time, and the FDA allowing a generic version marketed by Sun Pharma to be imported in order to ease the shortage.