Unease grows among U.S. doctors over Indian drug quality
WASHINGTON/NEW YORK Some U.S. doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration.
India supplies about 40 percent of generic and over-the-counter drugs used in the United States, making it the second-biggest supplier after Canada.
In recent months, the FDA, citing quality control problems ranging from data manipulation to sanitation, has banned the importation of products from Ranbaxy Laboratories Ltd, Wockhardt Ltd and, most recently, Sun Pharmaceutical Industries Ltd.
"I'm just beginning to realize the gravity of the problem," said Dr. Steven Nissen, head of cardiology at the Cleveland Clinic. "It's terrible and it is starting to get a lot of traction among physicians."
Indian drugmakers are by no means the only companies to recall products or be warned by the FDA about manufacturing problems. For instance, quality control failures at Johnson & Johnson forced the company to recall dozens of products over the past five years, ranging from artificial hips to children's Tylenol.
And last year, Germany's Boehringer Ingelheim said it would shut down its U.S. contract manufacturing unit, Ben Venue Laboratories, after it was cited for repeated manufacturing violations that led to shortages of the cancer drug Doxil.
India's drugmakers, a $14 billion industry, reject any criticism that their products are inferior to drugs made in other countries.
"We have heard doctors making generalized statements, without being specific on any product or company," said D.G. Shah, Secretary General of the Indian Pharmaceutical Alliance, a trade group representing large Indian drugmakers. "This is a deliberate and serious campaign to malign the Indian generic industry."
If U.S. doctors come across a medicine that does not meet quality standards, they should report it to regulators, he said. "Doctors are not in a position to judge whether manufacturing processes are correct or not. That is the U.S. FDA's job."
Generic drugs account for nearly 85 percent of medicines prescribed in the United States and the government is relying on them to help rein in healthcare costs.
"We are losing control over what people are swallowing," said Dr. Harry Lever, a cardiologist at the Cleveland Clinic who is trying raise awareness of the matter among U.S. lawmakers. "Now, when a patient comes in who is not doing well, the first thing I do is look at their drugs and find out who makes it."
Increasingly, Lever said, he is recommending patients seek out generic drugs from specific manufacturers outside India.
"I'm tending to stay away from India," he said. "There's something wrong. Too many things are happening."
INDIA DOCTORS HIT BACK
Indian physicians do not share the concerns.
"Our drugs are being sold in many countries and being accepted, so we have no issues," said Narendra Saini, Secretary General of the Indian Medical Association, a voluntary body of 215,000 doctors. "How do I know that Western drugs are better than our drugs?"
A 2012 report by India's parliament alleged collusion between pharmaceutical firms and officials at the Central Drugs Standard Control Organization (CDSCO), the country's drugs regulator, and described an agency that was both understaffed and underqualified.
Saini said physicians trust that the CDSCO is taking care of the quality and the standard of the drugs made in India.
"We very much trust those medicines," he added.
Representatives of Ranbaxy, Sun and Wockhardt were not immediately available to comment.
Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in New York, said he is concerned about the quality of generic drugs in general, not just those from India. He cited, as an example, his experience with the diabetes drug metformin.
"When patients open the bottle of medication it smells like dead fish," he said. Zonszein did not know which company made the foul-smelling drug.
Physicians do not have a say in which generic drug a patient receives, as that depends on which products are stocked by individual pharmacies. If a patient wants to avoid a certain manufacturer, he or she may have to change pharmacies.
Doctors may specify that the branded version of a drug be dispensed, but insurance companies frequently refuse to pay for them.
Dr. Richard Kovacs, who heads a number of American College of Cardiology committees and sits on its board of trustees, said doctors may need to play a greater role monitoring the medications prescribed by their practices.
"The average U.S. cardiologist has been able to assume that the drugs were safe and effective. It now appears we need to be more vigilant as a profession, and assist the FDA by reporting cases where we are concerned about irregularities in the drugs supplied to our patients," he said.
HARD TO KEEP UP
FDA Commissioner Margaret Hamburg, who recently returned from her first official visit to India, is urging greater collaboration between the two countries. During her 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.
Shortly afterwards, India's drug controller general, G.N. Singh, said in an interview that the country will follow its own quality standards.
"The FDA may regulate its country, but it can't regulate India on how India has to behave or how to deliver," he said.
Some companies seem to be responding to the FDA's actions.
Piyush Nahar, an analyst with Jefferies India Private Ltd who recently met with a number of Indian drugmakers, said in a recent report that most companies "have increased their investment" in compliance and some are considering investing in U.S. or European facilities "to overcome challenges relating to both regulations and perceptions."
The array of recalls and warning letters can be dizzying.
Ranbaxy recently recalled more than 64,000 bottles of a generic cholesterol-lowering drug after doses were mixed up in a bottle, and Sun began recalling 2,528 bottles of a diabetes drug after a bottle was found to contain an epilepsy treatment.
Those mix-ups follow a recall in January by Dr. Reddy's Laboratories Ltd of more than 58,000 bottles of its heartburn drug lansoprazole due to a microbial contamination.
"It's hard to be sure on a day-to-day basis with the array of medications that you have to be potentially aware of that there's a specific problem with a specific medication from a specific generic manufacturer," said Dr. Elliott Antman, a cardiologist at Brigham and Women's Hospital in Boston.
The medical community is dependent on agencies such as the FDA, he added. "The bottom line for me is we have to make sure they have sufficient resources to do their job correctly."
To Dr. Jason Gaglia, a diabetes expert at the Joslin Diabetes Center in Boston, the warning letters and import bans indicate the FDA is doing its job.
"Is it scary? Yes. But to me it means the system is working," he said.
(Reporting by Toni Clarke in Washington and Bill Berkrot in New York; Additional reporting by Zeba Siddiqui in Mumbai; Editing by Michele Gershberg, Frank McGurty and Eric Walsh)
WASHINGTON/NEW YORK Some U.S. doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration. India supplies about 40 percent of gen
NEW DELHI/MUMBAI Indian drug retailers shut up shop for the day on Wednesday to protest against the country's growing online pharmacy industry, and threatened to close indefinitely if the federal government did not shut down e-pharmacies. The nationw
MUMBAI The U.S. Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action. The FDA's "import alert"
MUMBAI Indian drugmaker Wockhardt hid the results of failed tests and deleted data from its systems at a plant in western India, according to a report by the U.S. Food and Drug Administration sent to the company earlier this month and seen by Reuters
LOS ANGELES U.S. oncologists, aware that patients are paying more of the costs of expensive cancer drugs, are increasingly declining to prescribe medicines that have scant or no effect, even as a last resort. At least half a dozen drugs, including co
ZURICH Swiss drugmaker Novartis said on Thursday it would investigate alleged drug approval irregularities in India after a parliamentary report found the country's regulator colluded with pharmaceutical firms to speed up approval procedures. "We wil
MUMBAI U.S. inspectors visiting a factory in India owned by drugmaker Wockhardt Ltd in March found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six meters from the entrance to a sterile manufacturing are
NEW DELHI (Thomson Reuters Foundation) - Indian Prime Minister Narendra Modi must not give in to U.S. pressure to change intellectual property laws which allow India to produce generic medicines poor people can afford, the medical charity Doctors Wit
HONG KONG Acupuncture may be helpful in alleviating menstrual cramps, which affects up to half of all young women, an extensive review of past studies has found. In a review of 27 studies that involved nearly 3,000 women, researchers from the Orienta
CHICAGO The skyrocketing cost of new cancer treatments is putting advances in fighting the deadly disease out of reach for a growing number of Americans. Cancer patients are abandoning medical care because the costs are simply too high and medical bi
LONDON Europe set out plans to boost research into the neglected area of antibiotics on Thursday by promising to accelerate approval of new drugs, while ensuring adequate prices for their makers and promoting industry-wide R&D. Multi-drug resistant b
NEW YORK (Reuters Health) - For cancer patients, a good death may have more to do with simple human values than with the latest medical treatments, a new study suggests. People who got treatment at intensive care units (ICU) or died in the hospital,
n">A spate of regulatory warnings for India's generic drug manufacturers will add a new emphasis on the quality of such medicines in an industry long dominated by the ability to deliver treatments as cheaply as possible, analysts say. In the short
NEW YORK Spending on prescription drugs is projected to have risen to $457 billion in 2015 and will likely continue to grow as a percentage of overall healthcare spending, a U.S. government health agency said on Tuesday. The agency also proposed a te
LONDON GlaxoSmithKline moved to consolidate its lead in a new class of three-in-one inhaled lung drugs on Thursday with plans to file its product for U.S. approval by the end of 2016, rather than the first half of 2018 as previously expected. Britain
CHICAGO To improve the quality of colon cancer screening for employees of Caterpillar Inc, Dr. Mike Taylor decided to make doctors compete for its business. The Peoria, Illinois-based, company, which is the world's biggest maker of construction and m
n">Medical providers have begun to think more about cost, as well as safety and effectiveness, when they decide on cancer treatments. In the past, pharmaceutical companies could launch a high-priced drug with little push back. But now, there is mo
LONDON GlaxoSmithKline's drug sales in China slumped 61 percent in the third quarter, hit by a bribery scandal that damaged its ability to market products in the country and pushed some sales into the hands of rivals. Chief Executive Andrew Witty sai
ZURICH Pharmaceutical group Roche said it secured an injunction from an Indian court banning generic drug makers Biocon and Mylan from comparing their copycat versions of Roche's Herceptin breast cancer treatment to the original. Mylan and Biocon, wh
MUMBAI Indian drugmaker Wockhardt's steps to have the United States lift bans on products from two of its plants are unlikely to approved until next year, its chairman said on Monday after the company posted a heavy fall in quarterly profit. Last yea
- 03-301Depression - Ich habe Lexapro seit Ende Januar nehmen. Ich begann auf 20 mg. und mein PDOC?
- 01-162Sollen Sie Ihre Zeit, während auf Camila zu bekommen?
- 03-113Low-Fat Milchprodukte
- 03-164Können Sie Antazida, während auf Nexium?
- 04-305Actelion's macitentan meets goal in study
- 03-266Hat Calcium mit synthroid stören?
- 04-257Hilfe / Identifizieren blaue Flüssigkeit aus 1950 med?
- 10-088Die Trübe Wahrheit über Leaching-Plastikflaschen
- 11-019Bibelverse über Laufen
- 12-221Ich trinke regelmäßig, was einige große Mengen von Alkohol in Betracht ziehen würden, 6 Bier pro Tag und mehr auf das?
- 11-022Toxic chemicals found deep at BP oil spill site
- 08-113Bipolare Störung - Gibt es helfen, Medikamente zu erhalten, wenn Sie keine Versicherung haben und der Staat wird nicht helfen?
- 02-184Technologie: Gefangen in der "Net
- 05-075Behandlungsprogramm Aussteiger
- 07-206Was ist das Äquivalent 10mg zu Lorcet 10/650 von oxycondin?
- 08-097Das Hormon Surges Das Halten Gewinner Gewinnen
- 02-068Juliana Survivor Geschichte
- 03-309Die leistungssteigernden Wirkungen von Tongkat Ali
- Vergleiche zwischen dem Depo Provera Schuss und mirean?
- Kalziumkanalblockern - Nebenwirkungen?
- Die Combo Meal Mindset
- Ich halte eine kleine Flasche Nitroglyzerintabletten, und haben bisher keine Schmerzen in der Brust hatte. Wann?
- Duke, County Durham Land $ 6M Zuschuss für Diabetes Gesundheits-IT-Initiative
- Science Center zu $ ​​15.000.000 Stiftung für Proof-of-Concept-Programm erhöhen
- Morgen lesen: Kid-Size-Regeln für die CT-Scans, wachsenden Milliarden-Dollar-Geldstrafe Club
- Schwangerschaft und Rückenschmerzen
- Was sind die möglichen Gefahren oder Nebenwirkungen der Langzeitanwendung von Restful Beine Hyland?
- Kann ich Benzonatate, wenn es im Jahr 2004 vorgeschrieben war?
- Promethazin Reaktion?
- Ich habe da auf Spireva verschwommenes Sehen entwickelt, ist es sicher Einnahme zu halten?
- Wie viel Neurontin ist in der Regel für Schlaflosigkeit benötigt?
- Wer ist das höchste Risiko einer HIV-Übertragung?
- Die glücklichsten (und anstrengendsten) Days of 2011 Revealed
- Longform Best Wissenschaft Geschichten des Jahres 2012
- Baby-Stuhl, Blut: Wenn Eltern sollten sich Sorgen machen?
- Essen Schlaganfall zu verhindern
- CHICAGO Hard economic times are hitting the United States' youngest citizens, threatening to roll back decades worth of gains in health, safety and education, according to a report released on Monday. It suggests the country's most severe recession i
- WASHINGTON More than 40 percent of U.S. adults who have depression are also smokers, meaning people need help with both if they want to quit, according to a U.S. government survey published on Wednesday. The survey found more than half of middle-aged
Prednisone - Hat jemand jemals hatte ein Arzt ihnen sagen, dass Prednison Leukozytenzahl erhöhen kann?meine Frau hat eine Wicht boold Zahl von 29.000 und der Doc sie nach Hause geschickt, weil er sagte, dass es auf Grund war ihr vor für 3 Wochen Einnahme Prednison wurde; und dass diese Zahl nicht zählen ----schneiden---- In Antwort auf 2011-03-06 19:
- Gestartet Lyrica heute für Nerven damge von Ovarialzyste wieder ein paar Monate Bersten. Würde gerne für mich die Leute ihre Bewertungen zu geben, auf diese med. Sowohl gute als auch schlechte. Zwei Fragen an der Spitze von meinem Kopf, sind Gewichts
Eisenmangelanämie - Ist Eisenmangel Ursache Beinzuckungen? Wie sich in Restless-Legs-Syndrom?In der Nacht meine Beine zucken und es hält mich wach die ganze Zeit. Ich war dumm und didnt meine Eisenpille für eine Woche dauern, bekam dann meine Zeit so alle meine Symptome kam zurück. Ich habe bemerkt, dass, wenn ich dont meine Pille meine Bein
- Ich habe nie irgendwelche Probleme zu erwarten, aber am nächsten Tag nach dem Eingriff immer ich mit geschwollenen Hals aufwachte, Brust, Arme, Hände und anderen Orten. Dann Horner-Syndrom, aber das war normal. DANN ... eine sehr seltsame Ausschlag a
Wir werden nie wissen, ob Statine sicher sind Während kommerzielle Interessen kommen zuerst (Op-Ed)Credit: David Watkins | Shutterstock Dieser Artikel wurde ursprünglich am veröffentlicht . Das Gespräch Die Veröffentlichung dazu beigetragen , den Artikel zu Live - Science Expert Stimmen: Op-Ed & Insights. Was wissen wir über Statine kommt fast aus
- SimonDoggett / Flickr PROBLEM: Skipping Frühstück ist stark mit Gewichtszunahme korreliert. "Beginnen Sie Ihren Tag ab", nicht wahr? Jugendliche essen fast die Hälfte ihrer täglichen Kalorien zwischen 16.00 und Mitternacht Trotzdem. Also, essen
- 1 Sie können diese herrlichen Papier Dahlien in ein paar einfachen Schritten. Suchen Sie eine einfache Handwerk mit Kindern zu tun? Diese hübschen Papier Dahlien sind so einfach zu machen, werden Sie wollen ein Bündel erstellen und verwenden sie das
- 1 3D Ultraschall - Lächeln bei 15 Wochen Sie sind 15 Wochen schwanger. Wie geht es Ihnen? Eingewöhnung, um den zweiten Trimester zu genießen? Das Baby hat seine wilden Sprint im ersten Trimester und bekam viel zu tun. Während Sie denken, würde es ein
- Was Ruft Good Service in LA
- Ich begann vor Levora 2 Wochen. dies ist das erste Mal, dass ich auf Geburtenkontrolle waren. 2 Nächte vor i?
- Ich war auf Lyrica und obwohl es wirksam war ich hatte aufgrund der Schläfrigkeit zu stoppen?
- Dr. sendet eine 4 Jahre alte Haus mit einem Objekt im Ohr?
- Naprelan - Können Sie jemand verklagen für Geschwüre, indem Naproxin zu bekommen?
- Wie schlimm ist Verstopfung, wenn Vesicare verwenden?
- Ich habe die Nebenwirkungen von Metformin lesen, aber nicht finden können, wenn es eine kleine Nebenwirkung mit der ist?
- Welche Ratschläge und Anregungen könnten Sie bieten für jemanden, verstrickt mit Ausbuchtung diffuse Scheibe bemerkt an?
- Enbrel Ursache Muskelschmerzen und enge Achillessehne kann?
- Boston Scientific, genehmigt Medtronic für neue Produkte Vorhofflimmern