Five years ago, when U.S. regulators first discovered that Ranbaxy Laboratories was manufacturing subpar drugs and lying to them about it, Indian officials took a quick look and then left it to the FDA to sort out. But in a better-late-than-never regulatory move, one of the country's drug watchdogs says it will revisit the issues that led Ranbaxy to recently plead guilty in the U.S. to multiple felonies and pay $500 million in penalties.
The Drug Controller General of India (DCGI) will start with inspections of the two plants at Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh that U.S. authorities say were responsible for the problems, The Economic Times reports. But that is just part of the plan. It is also asking the company to cough up details about the problems that led to the 7 felony convictions and massive penalties. And it says Indian law gives it the authority to take the inquiry in other directions if it chooses.
The head of the DCGI, G.N. Singh, recently said his agency was creating a policy for what its response should be in the face of actions by foreign regulators. The decision to flex its regulatory muscle appears motivated by outrage to the situation which has been growing since Ranbaxy and the U.S. Department of Justice outlined the settlement last month. Some Indian hospitals and the country's largest pharmacy chain have temporarily stopped using Ranbaxy drugs in the face of consumer concern. An Indian lawyer has also filed a citizen's petition asking India's Supreme Court to probe the matter, although justices Monday told him he needed more than media reports to hang his case on.
Ranbaxy has responded to the backlash but pointed out several times that it has taken huge strides since 2010, investing millions of dollars in quality and plant improvements. As part of its agreement with U.S. regulators, it has to operate for 5 years under strict oversight, paying for outside experts who can report it to the FDA if it shows signs of slipping into its old ways.
In an interview with The Economic Times, India's Health Minister, Keshav Desiraju, pointed out that plant inspections in India were the purview of state officials. He said the federal government needed to take a look, but also said the government was planning an image-building campaign for India's generic drug manufacturing industry. "Clearly, questions are being raised on the quality of drugs after this episode, but we cannot have a knee-jerk reaction to this sensitive case," he said.
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