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The reputation of India's massive $15 billion drug industry is being threatened at the federal and state level by a lack of properly trained personnel and a shortage of funding that points out possible changes may be needed in how the country finances inspections and quality control work…almost half of all regulatory positions in the country's central and state drug offices remain unfilled and that "existing staff (are) not trained to meet the regulatory requirements of the growing sector."…Officials…said the government's recommendations of having one inspector for 50 manufacturing plants and retail outlets means the country should have 3,200 inspectors, but in reality the country only has 846 currently working…This means key regulatory functions such as inspections are undertaken in an ad-hoc manner…There is a risk of large-scale corruption because inspectors perform sensitive functions, including launching of prosecution...

More than 100 women who became pregnant after allegedly taking mispackaged birthcontrol pills filed suit in Philadelphia last week against Qualitest Inc., a subsidiary of the Irish drug-maker Endo Pharmaceuticals Inc…The case seeks millions in damages, including in some cases the costs of delivering, raising, and educating the children borne of the unplanned pregnancies…The discovery of the mispackaged contraceptives prompted the FDA in 2011 to issue a recall notice for 3.2 million blister packs, according to court filings…. The FDA recall was triggered when a Kansas City woman returned a package to her pharmacist after noticing the blister pack had been rotated 180 degrees, reversing the weekly tablet orientation, according to the suit filed in Philadelphia Court of Common Pleas.

Report says small thefts may indicate syndicates are scoping out targets…Drugmakers have stepped up their game in recent years in protecting their supply chains against cargo theft. But thieves can be resourceful, and a big jump in losses in the third quarter indicates ways in which they have evolved their own techniques…In its Q3 report on U.S. cargo theft, FreightWatch International reported that while cargo thefts across all categories were down 18% and pharma thefts accounted for only 6% of total incidents, the numbers of cargo thefts in the drug industry increased a whopping 125% over the previous quarter and 350% over the same quarter a year ago…The industry continues to work with law enforcement to detect trends, and it has paid off with some arrests and convictions.

…Americans overdose and die after taking opioid painkillers...people abuse or misuse the drugs…addictions and deaths mount…authorities are struggling to cope…State lawmakers are introducing bills to restrict prescribing…Food and Drug Administration is pushing pharmaceutical companies to develop more tamper-resistant products…the most sweeping initiative comes from the Centers for Disease Control and Prevention, which has prepared preliminary prescribing guidelines for primary care physicians…call on doctors to prescribe opioids only after other therapies have failed…there is considerable opposition to the guidelines…critics…say the CDC guideline process was flawed and, as a result, some patients will be denied much-needed pain relief.

Irmat Pharmacy…looks like the neighborhood drugstore it has been since the 1970s…But two years ago it added a new business as a nationwide mail-order dispenser of expensive drugs for acne and other skin conditions…business has prospered…a large pharmacy benefit manager plans to stop doing business with it at the end of this month. Irmat is suing that company, OptumRx…It appears to be the latest skirmish in a budding war between pharmacy benefit managers, which seek to rein in spending on drugs, and mail-order pharmacies, which have been increasingly enlisted by drug manufacturers to help protect their products from being swapped for cheaper generic alternatives…a spokesman for Optum, said Irmat was being removed from Optum’s network because it violated its contract…Irmat receives most of its revenue from dispensing dermatology drugs made by two companies, Galderma and Aqua Pharmaceuticals…mail-order pharmacies say the real reason they are being targeted is that the pharmacy benefit managers own their own mail-order businesses and are trying to stifle competition…

How do dangerous narcotics cartels smuggle their goods into the U.S. and what is the human cost of their operations? The Onion explains the drug trade. (humor warning - may not be suitable for all audiences)

China has signaled a tougher stance on drug quality in the country’s sprawling pharmaceuticals industry by rejecting applications for 11 medicines with inadequate or suspect clinical data…China Food and Drug Administration said…that the move affected eight Chinese companies making generic drugs for heart problems, schizophrenia, pain, infections and other diseases…The crackdown follows a call in July for manufacturers to carry out their own internal investigations into trial data, which had already led to a number of voluntary recalls…The CFDA then carried out a series of on-site inspections…and discovered that clinical trial data in applications from eight companies for 11 drug products were incorrect or incomplete…“We have decided to withhold approval from these applications,”...

• Hainan Pharmaceutical
• Zhejiang Huahai Pharmaceutical
• Hebei Pharmaceutical
• Qingdao Bai Yang Pharmaceutical
• Zhejiang Angli Kang Pharmaceutical
• Hainan Kang Chi Pharmaceutical
• Guangdong Pharmaceutical
• Shandong Da Yinhai
  

Novartis's heart drug Entresto cuts the risk of re-hospitalization might have helped Chief Executive Joe Jimenez realize his ambition of getting insurers to pay more for treatments when they cut overall medical costs…Instead Jimenez and Severin Schwan, CEO of cross-town rival Roche, have been forced to concede that insurance companies…are not yet ready for such "outcome-based" pricing models…A key hurdle…is that electronic medical record systems aren't capable of accurately tracking a drug's role in reducing hospital stays or preventing further trips to the emergency room…This gap has largely stymied a push to change how drugs are priced and reimbursed by insurers and governments, even though both CEOs contend today's pay-per-pill approach can't be sustained…Drugs account for only around 10 percent of U.S. healthcare costs, Jimenez said, with hospital stays, medical personnel and other costs making up the rest. But existing records systems aren't up to the task of putting this data into perspective.

Avoiding pre-market verification is downright easy…Theranos isn’t alone in avoiding regulation using an easily exploited loophole — in fact, it’s just one among many…Pathway Genomics, Admera Health, and Strand Life Sciences are diagnostics companies that offer cancer tests that impact people’s health care decisions. None of these companies have published data about their tests in peer-reviewed journals. Nor were any of these companies required to show regulators that their tests worked before they started marketing them to patients and physicians. That’s because each of these companies has been making use of what's known as the "laboratory developed test" loophole — which makes avoiding pre-market verification downright easy...Under the LDT loophole, any company that develops and conducts a diagnostic test in their own lab…can avoid submitting that test to the FDA before using it on patients. This get-out-of-regulation-free card exists because research hospitals often modify commercial tests. In the case of these hospitals, the academic researchers tend to publish their results anyway…The FDA knows this — even they’ve been calling LDTs a loophole — and the agency wants to change the way these tests are regulated…until that loophole closes, we’ll keep seeing companies using the LDTs as a dodge, because it’s a simpler and cheaper way to get to market. The real expense, of course, is patients’ health.

U.S. prosecutors plan to ask the Canadian and British governments to extradite officials with an online pharmacy on charges of smuggling $78 million worth of mislabeled, unapproved and counterfeit cancer drugs into the country to sell to doctors…Fourteen companies and individuals from Canada, the United Kingdom, Barbados and the U.S. are accused of participating in the conspiracy that involved falsifying customs declarations for shipments from the U.K., according to the criminal indictment…Winnipeg-based Canadadrugs.com and its CEO, Kristjan Thorkelson, are accused of spearheading the conspiracy, aided by a subsidiary in the U.K., River East Supplies Ltd., and two subsidiaries in Barbados, Rockley Ventures Ltd. and Global Drug Supply Ltd.