India’s Hetero Labs has gained attention by launching biosimilars of some of the world’s top cancer drugs in its home country. But now, the Hyderabad-based pharmaceutical firm has drawn scrutiny from the FDA for some dubious practices at a formulations manufacturing plant in Jadcherla.
The FDA said in a Form 483 that video footage showed workers shredding what appeared to be manufacturing and packaging documents at 1 a.m. in the morning four days before an FDA inspection, Bloomberg reports, citing the document that was received through a Freedom of Information Act request.
The company claimed workers were only cleaning but then had no good explanation for why it needed a shredder, or for the suspicious timing of the work.
Hetero, which has launched biosimilars of cancer meds Avastin and Rituximab in India, did not respond to the news service’s request for a comment.
The FDA, however, did respond when was asked about the Hetero Form 483. “When the FDA finds that manufacturers lack sufficient controls over the integrity of their data, or worse, when firms intentionally violate such controls, those manufacturers’ practices raise questions about the accuracy, reliability, and truthfulness of all the data and information they collect and report,” FDA spokeswoman Lyndsay Meyer told Bloomberg. “While some Indian companies meet U.S. product quality standards, others do encounter problems and operational challenges.”
Siddhant Khandekar, an analyst with ICICI Securities in Mumbai, told Bloomberg that some drugmakers believed that many of the FDA actions were behind them after a surge in inspections by the agency in recent years. But as they have found, “you can’t take the U.S. FDA for granted,” Khandekar said.
India’s Sun Pharma had hoped that issues at its key U.S. production plant in Halol were behind it when it recently invited the FDA back for a re-inspection of the facility. The visit did not go as Sun hoped. Instead of a clean bill of health, the FDA issued a new Form 483 for the facility with more than a dozen observations, Sun reported in December.
While Sun has been able to ship products from the facility, it has been prevented from launching any new products from the Halol site, which received a warning letter last year. That has limited its revenue growth, which was up for H1 primarily on the strength of its 180-exclusive sale of a generic of Gleevec, a top-selling Novartis product. Sun was forced to shift production of the generic out of Halol to another facility in order to make its U.S. debut.
Sujay Shetty, who oversees the life sciences unit at PwC in India, said Indian companies are aware that the FDA actions have affected the industry’s standing in the world.
“On the Indian side, they are mindful from a reputation standpoint this is not doing any good,” Shetty told Bloomberg. “From a supply point of view—for your customers, for the functioning of your business—there’s a lot of disruption you have to deal with.”