By PAUL WALDIE
Tuesday, January 9, 2018
LONDON -- Apotex Inc. has run into trouble with British health regulators who have pulled the manufacturing certificate from the Toronto-based company's sprawling operation in India and restricted the importation of drugs made there.
Britain's Medicines and Healthcare products Regulatory Agency (MHRA) pulled the certificate last month after officials inspected the plant in Bangalore, which is operated by an Apotex subsidiary called Apotex Research Pvt. Ltd. In a report on its November inspection, the MHRA said the plant "does not comply with the Good Manufacturing Practices requirements" and it cited several failings related to non-sterile products, packaging and quality-control testing.
The report also warned other European Union countries to "contact the site to determine the level of risk associated with specific products released to market." And it added that "no batches [are] to be supplied to EU markets whilst this statement of non-compliance remains in force with the exception of products agreed in writing between [Apotex] and individual competent authorities based on continuity of product supply being critical for continued patient treatment."
The regulatory action comes at a time of turmoil at the generic drug maker. Company founder, Barry Sherman, 75, and his wife, Honey, 70, were found dead at their Toronto home last month and police are still investigating what happened. Mr.
Sherman played a critical role at Apotex up until his death. Although he had stepped down as chief executive officer several years ago, he remained chairman and was still the company's chief formulation officer, designing virtually every dose formulation. It's unclear how his role will be replaced or what financial impact his death will have since the company is privately held.
The MHRA carries out regular inspections of plants that produce medical products licenced for the British market. A Good Manufacturing Practices certificate is the minimum standard that a drug maker must meet in their production process. "Factories will be inspected when you apply for a manufacturer or wholesaler dealer licence and then periodically based on risk assessments," an MHRA official said in an e-mailed statement.
"Overseas manufacturing sites are also inspected." The official added that "critical findings from MHRA inspections are infrequent."
Jordan Berman, an Apotex spokesman, said the company is working to resolve the MHRA's issues. "Apotex is taking a number of steps to address MHRA feedback including quarantining all EU destined products manufactured at [Apotex Research] that have not yet been released to market, and initiating risk assessments," he said in an e-mail.
All regulatory "agencies whose markets are supplied with finished products from [Apotex Research] have been contacted and advised of this development. Non-essential medicines are being held pending outcome of MHRA discussion."
He added that "manufacturing and release of products for non-EU markets will continue, and data driven risk assessments have been performed that show all of our products meet required release specifications where a perceived potential risk was emphasized."
India has been a growing part of Apotex's worldwide operations and last July it opened a 42,000-square-foot "global business services office" in Mumbai.
The Bangalore plant has been operating since 2004 and it now has more than 2,500 employees who develop and manufacture products for the United States, Canada, the EU and Australia.
This isn't the first time the Indian operation has run into problems with regulators. The U.S. Food and Drug Administration raised a number of serious concerns about the plant in 2014 and 2015, including a failure to keep proper laboratory and computer records; and improper quality-control measures. The company responded to the concerns and in December, 2016, the FDA acknowledged that the violations had been addressed.
Empty pill bottles are filled at the Apotex plant in Toronto in 2011. A British regulator determined the firm did 'not comply with the Good Manufacturing Practices requirements' in an Indian plant.