WASHINGTON Feb 21 The head of the U.S. Food and Drug Administration said on Friday it was not unduly targeting drug companies in India, which supplies a large portion of drugs used in the U.S., as the agency cracks down on substandard medication from abroad.
In recent months, the FDA banned drugs and drug ingredients from two Indian companies, Ranbaxy Laboratories Ltd and Wockhardt Ltd, citing quality concerns. Some Indian officials say the U.S. is disproportionately targeting Indian companies for enforcement actions.
FDA Commissioner Margaret Hamburg, who recently returned from a 10-day official visit to India, rejected those charges, saying that her agency was simply "undertaking our required regulatory activities" needed to protect public health in the United States.
India supplies about 40 percent of the generic and over-the-counter drugs consumed in the United States, making it the second-largest supplier after Canada. Yet quality control problems have long plagued India's drug industry, largely due to a weak regulatory system.
In 2012, a report by India's parliament alleged collusion between pharmaceutical firms and officials at the country's Central Drugs Standard Control Organization (CDSCO), which oversees the licensing, marketing and trials of new drugs. It described an agency that was both chronically understaffed and underqualified.
The country is trying to improve but the task facing both local and overseas inspectors is difficult. The FDA has 12 members of staff in India, while about 500 Indian companies are registered to export drugs to the U.S.
The FDA staff is tasked with fostering communication with their Indian counterparts and can inspect facilities.
Dr. Amir Attaran, a professor of law and medicine at the University of Ottawa, noted that "even if you put a huge number of FDA staff in New Delhi, they have no legal power, no ability to do surprise inspections, no ability to issue subpoenas or take other measures to force a drugmaker to open its books."
"They are foreign agents in a foreign land," he said.
During Hamburg's visit, the FDA and India's Ministry of Health and Family Welfare signed a statement of intent to cooperate to prevent the distribution of unsafe drugs.
The statement is not binding and has no enforcement power behind it. Among other things, the FDA agreed to inform India's regulatory authorities before inspections so that local inspectors can observe.
The ink on the statement was barely dry when the drug controller general of India, G.N. Singh, said in an interview that India would follow its own quality standards and that "the FDA may regulate its country, but it can't regulate India on how India has to behave or how to deliver."
Singh said his agency regularly inspects manufacturing facilities in India and that it plans to raise the number of inspectors to 5,000 in three to five years, from about 1,500.
"We don't recognize and are not bound by what the U.S. is doing and is inspecting," he added.
Some observers are skeptical of India's commitment to improving quality standards.
Last year, Ranbaxy pleaded guilty to felony U.S. charges of shoddy manufacturing practices and data falsification and agreed to pay $500 million in civil and criminal fines. Dinesh Thakur, a former Ranbaxy executive who blew the whistle on the company nearly a decade ago, said no one in the Indian government has contacted him about the matter.
"Clearly this is not a priority for the Indian government at the moment," he said.
The FDA may be able to ban products from individual facilities but its ability to impose widespread restrictions on India's drugs is limited, since the U.S. relies on them so heavily.
"The dirty little secret in all this is that we can't do without Indian products," said Roger Bate, an economist at the American Enterprise Institute who will moderate a congressional briefing on global substandard and counterfeit medicines on Wednesday. "We have to negotiate and pressure because we can't boycott."
A group of critics, including Bate, Attaran and Dr. Harry Lever, a cardiologist at the Cleveland Clinic, plans to attend the briefing and hopes to put pressure on the White House to take up the issue of drug quality with the Indian government. Lever plans to discuss problems he is increasingly encountering with inferior-quality medicines.
"The Indian government needs to feel some pain on this," Bate said.
Hamburg repeated a call she made while in India for Indian regulators to step up their participation in discussions about global collaboration on drug production.
"India needs to be a full participant at the table," she said.