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Food and Drug Administration Commissioner Margaret Hamburg just wrapped up a trip to India to rebuild trust with her Indian counterparts in the wake of serial drug quality violations among Indian generic manufacturers. The quality lapses in India—which supplies more drugs to the United States than any other country—have become so unnerving that U.S. physicians are for the first time publicly voicing concern. At a recent event at the American Enterprise Institute, Dr. Harry Lever, a senior cardiologist at the Cleveland Clinic in Ohio, said he has found inconsistent quality among Indian generics and routinely switches patients off of them to secure therapeutic effect.
Independent data support these concerns. Study after study has shown that at least five per cent of Indian medicines sold in India fail basic quality control tests.
Unfortunately, India seems intransigent. In a recent interview with Business Standard, an Indian newspaper, the country’s Drug Controller General, G.N. Singh, was quoted as saying, “We don’t recognize and are not bound by what the U.S. is doing and is inspecting. The FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver.”
It is therefore no surprise that instead of making serious commitments during Commissioner Hamburg’s visit, Indian officials instead asked FDA to provide advanced notice of manufacturing facility inspections and let them “shadow” FDA inspectors—presumably to learn from FDA how they can hold their own inspectors to the highest standards.
This would be a mistake. By opening its playbook to India’s FDA—the Central Drugs Standard Control Organization (CDSCO)—the U.S. FDA may inadvertently make it easier for Indian companies to cheat, and to pass inspections as and when they happen, while conducting business as usual when they don’t. After all for Indian drug companies, even the most generous bribe would be far less expensive than failing an FDA inspection.
CDSCO has been repeatedly cited by the country’s own Parliamentary Committee on Health for corruption and colluding with local companies. Endorsement letters from doctors have been faked to secure marketing authorizations, products approved without conducting proper clinical trials, and bribes paid by companies to speed approval of products. Just last month, India’s Central Bureau of Investigation caught a CDSCO Deputy Controller red-handed accepting bribes to renew the operating license of a blood bank.
Training to secure the safety of American patients is an investment that FDA can and should make. But it must first ensure that it has a trusted and honest partner that wants to be trained. Before any such policy is put in place, FDA must secure a commitment from the Indian government to take drug quality seriously.
For starters, CDSCO should be run by a qualified public-health trained individual—not a political appointee, as is currently the case. If India doesn’t have such people, it should hire from overseas like it did for the Governor of the Reserve Bank of India. Furthermore, the position should rest at the Ministerial level, so cabinet meetings on drug policy are not dominated by the Commerce Department, which narrowly promotes Indian businesses and its drug companies regardless of quality concerns.
Before FDA opens up its inspections dossiers, CDSCO should spend at least one year showing the FDA how it inspects Indian facilities today and enforces its own standards to ensure quality medicines for Indian patients. If India wants its drug companies to continue to tap its largest export market, then the Indian government should be prepared to demonstrate that it is financing and equipping its own inspectors properly—and enforcing penalties when companies fail.
If and when the FDA starts sharing its inspection plans, the outcome should be monitored closely for undue influence and to see if warnings were provided to Indian manufacturers. This data ought to be provided publicly in the FDA’s annual report.
A good example of an effective approach to international enforcement is what the U.S. Federal Aviation Authority did last month when it found safety lapses among India-based air-carriers. It downgraded Indian aviation to category two, limiting their ability to serve the US market. The onus to take corrective action is now solely on Indian authorities. This approach provides strong incentive to the Indian government and its airline industry to get its act together.
Congress should take a page from this book and strengthen the FDA Safety and Innovation Act by imposing severe penalties in the form of trade barriers on any country that repeatedly exports poor quality medicine to America. It should also sunset funding for most foreign operations of the FDA at a future date. That will both save money and give the Indian government an incentive to strengthen CDSCO to a point where it ensures ongoing market access to America. Ultimately, it will improve safety for U.S. patients.
Dinesh Thakur is the Executive Chairman of Medassure Global Compliance Corporation. Roger Bate is the author of Phake: The Deadly World of Falsified and Substandard Medicine. Amir Attaran is a Professor in the Faculties of Law and Medicine at the University of Ottawa.
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