Buy Prescriptions From India
Bigsby first made contact with the "buyers club" through a blog written by Greg Jefferys, an Australian who also suffered from Hepatitis C. The posts recounted Jefferys' 2015 trip to Chennai, an Indian city on the Bay of Bengal, to buy sofosbuvir.
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Jefferys says he gets up to 100 emails per day from people seeking advice -- half of them from America. Some travel to India to purchase the drugs themselves; others ask Jefferys to arrange for the drugs to be mailed to their homes.
Drug pricing has come under intense public scrutiny in the U.S. after Martin Shkreli, as CEO of Turing Pharmaceuticals, hiked the price of a medication used by HIV/AIDS patients from $13.50 to $750 per pill, earning him broad condemnation.
The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place in January.
During Operation Broadsword, investigators from both governments examined more than 800 shipments, which identified approximately 50 different FDA-regulated products, including medications intended to treat and or mitigate serious diseases, such as various forms of cancer and HIV. Many of the shipments, which included opioid drugs products, had been transshipped through third-party countries to conceal their point of origin and avoid detection. Health risks are further compounded when products are sent through such third-party countries, which undermines protections afforded via regulated pharmaceutical supply chains.
Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being passed off as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe. In addition to health risks posed by these products, illegal online pharmacies can pose other risks to consumers. These include the risk of credit card fraud, identity theft and computer viruses.
The high cost of prescription drugs continues to be a top health priority for the public. Policymakers at the federal and state level are pursuing a range of options to lower drug prices for Americans, one of which would allow for the safe importation of prescription drugs from Canada and other countries, based on evidence showing that people often pay more for medications in the U.S. than elsewhere. In an executive order issued July 2021, President Joe Biden directed the Food and Drug Administration (FDA) to work with states to import prescription drugs from Canada, an approach that was put into place by the previous Administration and has bipartisan support among the general public (Figure 1).
Current law allows for the importation of certain drugs from Canada under defined, limited circumstances, and only if the Secretary of the United States Department of Health and Human Services (HHS) certifies that importation poses no threat to the health and safety of the American public and will result in significant cost savings to the American consumer. In September 2020, the Trump Administration issued a final rule and final FDA guidance, creating two new pathways for the safe importation of drugs from Canada and other countries, and then-HHS Secretary Alex Azar certified that importation of prescription drugs poses no risk to public health and safety and would result in significant cost savings.
The Medicare Modernization Act of 2003 (MMA) amended the Section 804 importation language that was added by the MEDS Act. The MMA specifies that wholesalers and pharmacists can only import prescription drugs from Canada, not other industrialized countries. The MMA also authorizes the Secretary to terminate such importation programs if they do not meet safety standards or result in a significant reduction in costs for consumers. The MMA also requires the HHS Secretary to issue regulations that would grant waivers to individuals to import drugs for personal use under certain circumstances.
Importation of prescription drugs under conditions set forth first by the MEDS Act, and then by the MMA, could allow wholesalers and pharmacists to obtain FDA-approved drugs at lower prices than are available in the U.S. by purchasing them from foreign sellers, and pass these savings on to U.S. consumers.
In September 2020, the Trump Administration issued a final rule and final FDA guidance for the importation of prescription drugs. The final rule would authorize states, territories and Indian tribes, and in certain future circumstances wholesalers and pharmacists, to implement time-limited importation programs, known as Section 804 Implementation Programs or SIPs, for importation of prescription drugs from Canada only. States, territories, and Indian tribes could submit proposals to the HHS Secretary to manage these SIPs and act as SIP sponsors.
In order for a proposal to be approved by HHS, a SIP sponsor would need to specify: the drugs it seeks to import; the foreign seller in Canada that would purchase the drug directly from its manufacturer; the importer in the U.S. that would buy the drug directly from the foreign seller in Canada; the re-labeler or re-packager of the drug itself that would ensure the drug meets all labeling requirements in the U.S.; the qualifying lab that would conduct testing of the drug for authenticity and degradation; and steps that would be taken by the SIP to ensure the supply chain is secure. SIPs would initially be authorized for 2-year periods with the possibility of 2-year extensions.
Under the final rule, which allows states and other entities to facilitate importation of drugs from Canada, only drugs that are currently marketed in the U.S. would be eligible for importation. As under current law, certain types of drugs are excluded from the definition of a prescription drug eligible for importation including: controlled substances, biological products (including insulin), infused drugs, intravenously injected drugs, and inhaled drugs during surgery. Furthermore, drugs that are subject to risk evaluation and mitigation strategies (REMS), which are high-risk products with serious safety concerns, such as opioids, are not eligible for importation.
In most circumstances, it is illegal for individuals to import FDA-approved drugs from other countries for personal use. However, based on changes enacted by the MMA, personal importation of prescription drugs that have not been approved by the FDA for use in the U.S. is permitted on a case-by-case basis. Under this statutory authority, FDA has put out guidance that lays out certain circumstances where importation of non-FDA approved drugs for personal use might be allowed. For example, personal importation is generally allowed if the treatment is for a serious condition, there is no effective treatment available in the U.S., and there is no commercialization of the drug for U.S. residents. Typically, only a three-month supply is allowed, and individuals most confirm in writing that the drug is for personal use and provide information about the physician responsible for their treatment.
In 2015 (the most recent year with full data), 12.5 million people in the United States abused opioids, and it is estimated that 24,861 people died from overdoses of prescription and synthetic opioids. Some expect these numbers to have tripled for 2016, and six U.S. states have now declared public health emergencies to combat the opioid crisis. In October, President Trump declared the opioid crisis a public health emergency.
Fentanyl is at the center of the opioid crisis in the United States. It is used as a direct substitute for heroin, but it is 50 times more powerful than heroin. Fentanyl is a synthetic opioid, meaning it requires precursor chemicals to manufacture, and it is prescribed as a pain medication. In the past two years, however, illicit manufacturing and importing of fentanyl has skyrocketed. The death rate from synthetic drug use reflects this trend.
Fentanyl exported from China to the United States comes in several different forms: fentanyl, its precursor chemicals, fentanyl variants, and fentanyl-laced counterfeit prescription opioids. India exports many controlled and prescription drugs to the United States, including fentanyl. Indian fentanyl exports to the United States are a fraction of those from China, but India does export tramadol, which is a growing issue for the United States. However, unlike China, which has now designated over 100 fentanyl variants and precursors on its list of controlled substances, India has not placed fentanyl, or most other opioids, on its controlled substances list, easing production and export. India only regulates 17 of the 24 basic precursor chemicals for fentanyl (as listed by the UN 1988 Convention against Drugs).
Indian tramadol networks have even been linked to ISIS and Boko Haram, raising security concerns. There have been several instances of seizures of tramadol from India destined for Islamic State territory. In May, $75 million worth of tramadol, about 37 million pills, was seized in Italy en route to Misrata and Tobruk, Libya; ISIS had purchased them for resale to ever-growing markets. The group has been involved in both the trafficking and consumption of tramadol, and the quantity of drugs being purchased by ISIS is so great that it can be assumed the group is selling a significant portion for profit.
The 37 million tramadol tablets purchased by ISIS had taken a familiar route from India through Southeast Asia. Neither India nor many Southeast Asian countries regulate tramadol, and since tramadol is not on the international drug schedule, it is only regulated if individual countries decide to classify it. But, if only one country classifies the drug and places it under regulation, it will not necessarily affect the supply. This was a problem for Egypt, which scheduled tramadol in hope of curbing abuse. Despite this, Indian tramadol exports to Egypt continued to rise and tramadol is the most abused drug in Egypt today. 041b061a72