Ranbaxy's Toansa plant under Indian drug regulator's watch too [India Business]

01/31/2014 11:21:13 AM
Ranbaxy's Toansa plant under Indian drug regulator's watch too [India Business]
[Times of India]

Published Date: January 31, 2014 12:01:00 AM EST
Author: Das, Soma

NEW DELHI:India's drug regulator has ordered Ranbaxy to furnish a comprehensive explanation for the violation of manufacturing practices at its Toansa plant, discovered by the US Food & Drug Administration, which earlier this month banned the export of drugs manufactured at the unit.

The Drug Controller General of India (DCGI) has also dispatched a team of officials to inspect the plant. "The company has seven days, starting Monday, to explain violations cited by USFDA at the Toansa plant," Drug Controller General GN Singh told ET.

While Singh did not specify what steps the regulator would take if it found Ranbaxy's response to be unsatisfactory, any action by the local watchdog would deepen the drugmaker's woes. So far, USFDA has banned exports from three Ranbaxy plants in India, but Indian authorities have not taken any action, citing lack of evidence.

The USFDA, earlier this month, banned exports to that country from Ranbaxy's Toansa plant in Punjab, citing data integrity issues found during inspection. The US regulator also placed all of Ranbaxy's other India-based facilities on import alert. The US authorities had earlier banned exports from two other Indian plants of Ranbaxy, and last year the Indian drugmaker agreed to a $500-million penalty as it pleaded guilty to civil and criminal charges regarding manufacturing malpractices.

Singh said the regulator must work on the basis of evidence. "We have no evidence yet to establish that Ranbaxy has sold sub-standard drugs in the country," he said. Last year, the DCGI's office, along with respective state drug regulators, conducted inspections at seven Ranbaxy plants, including Dewas, Paonta Sahib, Baddi, Solan, Ponda and even Toansa.

"We did detect some violations from good manufacturing practices under Indian law, which was communicated to the company around the end of July. In September, it sent corrective actions that it proposed to take. Also, drug samples were drawn during these inspections and sent to government labs for testing," said Singh. While some samples have been found to be meeting standards, the results of a few others are awaited. A complete analysis is expected by the end of January.

Singh said regulatory action takes time. USFDA, the world's biggest drug regulator, took two years to impose its first import alert on the company's plants after it discovered deficiencies in 2006. "It took another five years for the consent decree and the fine against the company to come about. It takes time to establish wrongdoing, if there is any. We cannot take a radical action on a whim or a cue from another regulator," he said.

Singh also pointed out that there was a fundamental difference in the approach by the Indian norms and the US law. "Any violation in prescribed processes in the US can lead to a complete ban on a drug plant. In our case, any process deviation first leads to warning.

But if we detect any deviation from prescribed quality in case of a finished drug, we immediately suspend the drug," he said.

On being asked why a whistleblower of Indian origin chose to 'tell it all' to the US regulator instead of revealing his case to the Indian watchdog, Singh said the incident happened seven-eight years ago, when the country didn't even have a whistleblower scheme.

"We have one today, but it has not proved very effective till date. Most leads that we have got were either false alarms or insignificant. We are in the process of sprucing up our whistleblower programme and I believe in future it will turn into one of the most important tools for detecting wrongdoing," Singh said.

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