FDA warns India’s Sun Pharma over standards at Halol plant

23 Dec 2015 | Author: | No comments yet »

FDA warns Sun Pharma over standards at Halol plant.

MUMBAI: India’s largest drugmaker Sun Pharmaceutical Industries Ltd. has been warned by US health regulators for violating manufacturing standards at its Halol plant in India, even as it has been working on fixing issues at the plant for over a year.Seattle: United States President Barack Obama signed into law a measure easing a 35-year-old tax on foreign investment in US real estate, potentially opening the door to greater purchases by overseas investors, a major source of capital since the financial crisis.

The US Food and Drug Administration’s “warning letter” to Sun Pharma indicates the agency is dissatisfied with the remedial measures the company has implemented since last September, when the FDA first notified the company of its concerns after an inspection. Contained in the $1.1 trillion spending measure that was passed to avoid a government shutdown is a provision that treats foreign pension funds the same as their US counterparts for real estate investments.

That inspection report highlighted nearly two dozen issues the FDA staff found, including problems with aseptic practices and water leaks in the ceiling of the manufacturing area. The letter, which was publicized by Sun Pharma itself and has yet to appear on the FDA website, means the US agency could ban imports from the plant if the problems are not resolved. This is the latest setback for India’s pharmaceutical companies, which have struggled with quality issues under the increased scrutiny from the FDA. Warning letters are issued for violations of regulatory practices and these could lead to enforcement actions such as an import alert, if not promptly and adequately corrected in compliance with the US regulations.

Sun said it expects to seek a re-inspection by the FDA on completing its “remediation commitments.” “This situation may continue until all issues are resolved,” the company said. U.S. inspectors in September last year said they were concerned with how Sun Pharma workers at its plant handled quality-test data and the plant’s “sterile environment,” said Dilip Shanghvi, Sun Pharma’s managing director. Sun Pharma makes some of its most profitable products at the Halol factory, including pre-filled syringes that need to manufactured in a sterile environment. Shanghvi said the warning letter may have been issued because Sun Pharma had not “effectively” communicated to the FDA the extent of remediation work it had already done. “Whether the remediation commitments we made are adequate, whether we need to do more … these are issues we need to assess and understand and probably consult with additional subject matter experts,” he said.

Sun, which became the world’s fifth biggest generic drugmaker with its purchase of Ranbaxy Laboratories Ltd., faces the challenge of resolving U.S. import bans on four of Ranbaxy’s Indian facilities while maintaining its profitability. Reddy’s Laboratories Ltd. received an FDA warning letter citing quality control issues, including data integrity, at three of its manufacturing plants in India. Despite a perception that FIRPTA was a response to the wave of Japanese buying of trophy US property in the late 1980s and early 1990s, including Rockefeller Center and Pebble Beach, the act was actually passed in 1980 in response to international investors buying US farmland.

While analysts were factoring in the possible clearance for the Halol plant from the middle of FY17, the fresh warning letter means the resolution will now take longer.

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