Drug Patent Rights India Wins First Round Novartis Full Text


The instances of Multinationals stealing indigenous medicines is well-known.

So are the capricious overpricing of life saving Drugs, like Cancer Drugs.

The Intellectual Property Appellate Board rejected the German drug maker’s appeal of the 2012 ruling on Monday. It also ruled that under the license Natco must pay 7 per cent in royalties on net sales to Bayer.

Bayer sells a one month supply of the drug for about $5,600. Natco’s version would cost Indian patients $175 a month, less than 1/30th as much.

Western pharmaceutical companies have been pushing for stronger patent protections in India to regulate the country’s $26 billion US generics industry, which they say frequently flouts intellectual property rights. However, health activists and aid groups counter that Indian generics are a lifesaver for patients in poor countries who cannot afford Western prices to treat diseases such as cancer, malaria and HIV.’


http://ramanan50.wordpress.com/2013/03/23/cancer-drugs-combinations-prices/

Big Court Ruling Favors Generic Drugs: The Times’s Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world.

Big Court Ruling Favors Generic Drugs: The Times’s Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world.

India drew first blood in a Patent case in The Supreme Court .

Supreme Court , India,Judgement, Novartis Case

Supreme Court , India,Judgement, Novartis Case

‘People in developing countries worldwide will continue to have access to low-cost copycat versions of drugs for diseases like H.I.V. and cancer, at least for a while…

Production of the generic drugs in India, the world’s biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court.

Cost of Glivec used for targeted therapy in CML patients: 1 lakh per month (approx)

Cost of its generic versions : 8,000 -10 ,000 per month

No. of cancer centres in India: 450 approx (half are in the private sector)

 

The debate over global drug pricing is one of the most contentious issues between developed countries and the developing world. While poorer nations maintain they have a moral obligation to make cheaper, generic drugs available to their populations — by limiting patents in some cases — the brand name pharmaceutical companies contend the profits they reap are essential to their ability to develop and manufacture innovative medicines.

Specifically, the decision allows Indian makers of generic drugs to continue making copycat versions of the drug Gleevec, which is made by Novartis. It is spelled Glivec in Europe and elsewhere. The drug provides such effective treatment for some forms of leukemia that the Food and Drug Administration approved the medicine in the United States in 2001 in record time. The ruling will also help India maintain its role as the world’s most important provider of inexpensive medicines, which is critical in the global fight against deadly diseases. Gleevec, for example, can cost as much as $70,000 a year, while Indian generic versions cost about $2,500 a year.

The ruling comes at a challenging time for the pharmaceutical industry, which is increasingly looking to emerging markets to compensate for lackluster drug sales in the United States and Europe. At the same time, it is facing other challenges to its patent protections in countries like Argentina, the Philippines, Thailand and Brazil.

“I think other countries will now be looking at India and saying, ‘Well, hold on a minute — India stuck to its guns,’ ” said Tahir Amin, a director of the Initiative for Medicines, Access and Knowledge, a group based in New York that works on patent cases to foster access to drugs.

In trade agreements — including one being negotiated between the United States and countries in the Pacific Rim — the drug industry has lobbied for stricter patent restrictions that would more closely resemble protections in the United States.


http://www.nytimes.com/2013/04/02/business/global/top-court-in-india-rejects-novartis-drug-patent.html?nl=todaysheadlines&emc=edit_ae_20130401&_r=0

Full Text of The Judgement.

Largest Criminal Fines Assessed on Companies In US.


BP has  agreed to pay $4.5 billion in a settlement with the federal government over the April 2010 explosion of the drilling rig Deepwater Horizon. The agreement includes nearly $1.3 billion in criminal fines, with the rest of the money going to several government-related entities. The criminal fine is the largest in U.S. history and eclipses a 2009 fine against drug-maker Pfizer Inc.

BP Logo_/bp-4.jpg

BP Logo.

 

1. Following is the List of Heavy Fines imposed by The Justice Department, US.

$1.256 billion in criminal fines, November 2012, against BP PLC for various charges related to the 2010 explosion of the Deepwater Horizon and the resulting oil spill. An estimated 172 million gallons of crude spilled into the Gulf, fouling marshes and beaches, killing wildlife and closing vast areas to fishing. Eleven workers died in the blast. The spill was the nation’s worst offshore oil disaster.

2. $1.195 billion, October 2009, against Pfizer Inc. as part of a settlement of criminal and civil allegations that it promoted the anti-inflammatory drug Bextra for uses and dosages the Food and Drug Administration had rejected because of safety concerns.

3. $956.8 million, plus $43.2 million in forfeitures, October 2010, as part of a GlaxoSmithKline PLC settlement for misbranding the drugs Paxil and Wellbutrin and for failing to report post-approval studies of the drug Avandia to the Food and Drug Administration.

4. $700 million, May 2012, against Abbott Laboratories Inc. as part of a settlement for unlawful promotion of the prescription drug Depakote.

5. $515 million fine and $100 million forfeiture, January 2009, against Eli Lilly and Co. as part of a settlement for off-label marketing of antipsychotics.
 http://www.seattlepi.com/news/science/article/Largest-criminal-fines-against-companies-in-the-US-4041813.php#ixzz2CMzAj6UV

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Full List Of Banned Drugs in India * November 2012 Update


hphotos-prn1/c0.0.403.403/p403x403/530859_540882482593352_530047578_n.jpg

Banned Drugs in India.

The Ministry and the Pharma Companies are smart.Brand names may differ.Check out the different Brand names in different countries.

Check the Composition of the Drug.

Verify with FDA and EU whether the constituents of the Drug is banned.

Drugs Prohibited from the date of Notification

  1. Amidopyrine.
  2. Fixed dose combinations of vitamins with anti–inflammatory agents and tranquilizers.
  3. Fixed dose combinations of Atropine in Analgesics and Antipyretics.
  4. Fixed dose combinations of Strychnine and Caffeine in tonics.
  5. Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins.
  6. Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.
  7. Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs.
  8. Phenacetin.
  9. Fixed dose combinations of antihistaminic with anti-diarrhoeals.
  10. Fixed dose combinations of Penicillin with Sulphonamides.
  11. Fixed dose combinations of Vitamins with Analgesics.
  12. Fixed dose combinations of any other Tetracycline with Vitamin C.
  13. Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use.
  14. Fixed dose combinations of Corticosteroids with any other drug for internal use.
  15. Fixed dose combinations of Chloramphenicol with any other drug for internal use.
  16. Fixed dose combinations of crude Ergot preparations except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headaches.
  17. Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6).
  18. Penicillin skin/eye Ointment.
  19. Tetracycline Liquid Oral preparations.
  20. Nialamide.
  21. Practolol.
  22. Methapyrilene, its salts.
  23. Methaqualone.
  24. Oxytetracycline Liquid Oral preparations.
  25. Demeclocycline Liquid Oral preparations.
  26. Combination of anabolic Steroids with other drugs.
  27. Fixed dose combination of Oestrogen and Progestin (other than oral contraceptive) containing per tablet estrogen content of more than 50 mcg (equivalent to Ethinyl Estradiol) and progestin content of more than 3 mg (equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic Oestrogen and Progesterone. (Subs. By Noti. No. 743 (E) dt 10-08-1989)
  28. Fixed dose combination of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics.
  29. Fixed dose combination of Rifanpicin, isoniazid and Pyrazinamide, except those which provide daily adult dose given below: 
    Drugs Minimum Maximum
    Rifampicin 450 mg 600 mg
    Isoniazid 300 mg 400 mg
    Pyrazinamide 1000mg 1500 mg
  30. Fixed dose combination of Histamine H-2 receptor antagonists with antacidsexcept for those combinations approved by Drugs Controller, India.
  31. The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia.
  32. All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate.
  33. Fixed dose combination of Ethambutol with INH other than the following: INH Ethambutol 200 mg. 600 mg. 300 mg. 800 mg.
  34. Fixed dose combination containing more than one antihistamine.
  35. Fixed dose combination of any anthelmintic with cathartic/purgative except for piperazine/Santonim.
  36. Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine.
  37. Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.
  38. Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamol
  39. Fixed dose combination of centrally acting, antitussive with antihistamine, having high atropine like activity in expectorants.
  40. Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine.
  41. Liquid oral tonic preparations containing glycerophosphates and/or otherphosphates and / or central nervous system stimulant and such preparations containing alcohol more than 20% proof.
  42. Fixed dose combination containing Pectin and/or Kaolin with any drug which is systemically absorbed from GI tract except for combinations of Pectin and/or Kaolin with drugs not systemically absorbed.
  43. Chloral Hydrate as a drug.
  44. Dovers Powder I.P.
  45. Dover’s Powder Tablets I.P.
  46. Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.
  47. Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.
  48. Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.
  49. Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate Lorloperamide or Atropine or Belladona including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.
  50. Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines.
  51. Fixed dose combination of antidiarrhoeals with electrolytes.
  52. Patent and Proprietary Oral Rehydration Salts other than those conforming to the
  53. Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.
  54. Fixed dose combination of Analgin with any other drug.
  55. Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steriodal anti-inflammatory drugs (NSAIDS).
  56. Fixed dose combination of a drug, standards of which are prescribed in the Second Schedule to the said Act with an Ayurvedic, Siddha or Unani drug.
  57. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.
  58. Fenfluramine and Dexfenfluramine.
  59. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride.
  60. Rimonabant.
  61. Rosiglitazone
  62. Nimesulide formulations for human use in children below 12 years of age.
  63. Cisapride and its formulations for human use.
  64. Phenylpropanolamine and its formulation for human use.
  65. Human Placental Extract and its formulations for human use.
  66. Sibutramine and its formulations for human use, and
  67. R-Sibutramine and its formulations for human use.
  68. Gatifloxacin formulation for systemic use in human by any route including oral and injectable
  69. Tegaserod and its formulation for human use.

Source Pharma Tutor.


http://www.pharmatutor.org/pharmapedia/banned-drugs-in-india-manufacture-sale

Check out the following site as well.


http://cdsco.nic.in/html/Drugsbanned.html
  This is  Central Drugs Standard Control Organisation, Dte.GHS, Ministry of Health and Family Welfare, Government of India.


http://bharat-swabhiman.com/en/world-banned-medicines-sold-in-india/

http://cdsco.nic.in/html/Drugsbanned.html

 

 

 

 

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Clinical Testing of Drugs and Pharma Companies, Patents.


English: Logo of the .

Image via Wikipedia

Recently I came across an article in The Scientist on the Clinical trials of drugs in the US by the Pharma Corporations.

baby.

MATT COLLINS (BABY); US GOVERNMENT ACCOUNTABILITY OFFICE REPORT, “PEDIATRIC RESEARCH,” MAY 2011

Drugs ,it is reported that , are not tested on children and are marketed.

The FDA is of the opinion that Clinical Trials of Drugs conducted on Children give off reliable results,especially the contra-indications.

I am reproducing a real instance quoted in The Scientist.

But the story of Paxil also illustrates the power of somewhat obscure laws that have saved children’s lives by changing the way drugmakers test their products.

Paxil—which increases extracellular levels of the neurotransmitter serotonin by inhibiting its reuptake into presynaptic cells—was approved by the US Food and Drug Administration in 1992, and by 2000 it was making the drug company GlaxoSmithKline (GSK) $2 billion per year. But around this time, problems with Paxil began to surface. Adult and adolescent patients were anecdotally reporting side effects, including sexual dysfunction, weight gain, high blood pressure, and increased suicidality—an uptick in thoughts of suicide or self-inflicted injury in some severely depressed patients. These reports of increased suicidality particularly worried pediatricians.

In 1999 the FDA sent GSK a letter requesting that the company conduct clinical trials of Paxil in children and adolescents. To sweeten the deal, the FDA offered GSK a 6-month marketing exclusivity extension for Paxil in return. This extension, which in effect would buy GSK 6 extra months of patent protection by delaying marketing of generic versions, was an incentive written into the FDA Modernization Act (FDAMA) of 1997.

GSK eventually agreed to conduct the requested studies and submitted the results to the FDA sometime in early 2002, after FDAMA had expired and been replaced by the Best Pharmaceuticals for Children Act (BPCA) of 2002. Though GSK’s own reports on preliminary studies of Paxil in adolescents indicated that it was safe and more effective than a placebo—a heavily disputed interpretation contained in the article reporting the results of the now infamous study 3291—the FDA’s analyses of Paxil studies found that suicidal thoughts, suicide attempts, and episodes of self-harm were almost twice as high in young patients with major depressive disorder taking the drug than among those taking a placebo. To boot, the agency found that the drug was no more effective than placebo in treating major depression in children and adolescents”

The point to be noted is that the Company doctored the report.

Imagine a Corporation earning Billions of Dollars, despite getting a undeserved

6 months  of patent protection, the company thought it fit to doctor the

report,with scant report for Human Life.

The Companies dodge testing on Children because of Legal implications and high cost of testing on children.

Another point I note is that is testing drugs on Children Safe for them?

I also read an interesting comment  on Patents.

Featured Comment

Legislators should remember who pays their salaries and to whom they are responsible. If taxpayers fund any part of a research activity then (a) no patents or copyrights should issue as a result, and (b) all results and unprocessed data should be available freely, similarly funded by the taxpayers. If the researchers and their sponsoring organizations don’t like the bargain, they should seek funding from non-public sources.tddial, Elsevier Abandons Anti-Open Access Bill

VERY THOUGHTFUL AND VALID.


http://the-scientist.com/2012/03/01/are-the-kids-alright/#fn-21915-1

Beware of Canned Soup.


:Original raster version: :Image:Food and Drug...

Image via Wikipedia

All canned items, packet-ed foods and instant foods are harmful in certain cases cause serious illness.

Please read my blogs under Health.

But a little canned soup for lunch can dramatically increase exposure to the chemical, according to a study in the Journal of the American Medical Association.

The study confirms that canned food is a source of BPA exposure. But it does nothing to clear up the question of whether this sort of exposure to BPA has health consequences.

BPA is found in some plastic bottles and in the epoxy resins used to coat the inside of many food and beverage cans. Previous studies have shown that some BPA from can linings does get into the foods they hold.

Some scientists are concerned about BPA exposure because the chemical can act like the hormone estrogen, and studies show that high levels can affect sexual development in animals.

But people are exposed to much lower levels. And agencies including the Food and Drug Administration and Environmental Protection Agency haven’t found evidence that this exposure is causing problems.

In the new study, researchers at the Harvard School of Public Health compared people who were given canned vegetable soup for lunch each day with people who got vegetable soup made without any canned ingredients.

And they found that a couple hours after eating, the people who had canned soup had BPA levels in their urine that were about 12 times higher than the people who didn’t.

The levels were still within the range that government agencies consider safe.

Even so, “We were surprised by the magnitude of the elevation,” says Karin Michels, senior author of the paper. Michels says previous studies have found much less dramatic increases after people drank from polycarbonate bottles.

It’s unlikely that soup caused BPA levels to remain high very long, Michels says, because the body tends to excrete most BPA within a few hours. But she says levels could stay high for people who regularly consume foods and beverages from cans.

Michels says she can’t comment on the health implications of the finding because that wasn’t part of the study. Even so, she says, food makers might want to consider eliminating BPA from can linings.


http://www.npr.org/blogs/thesalt/2011/11/22/142672252/eating-canned-soup-makes-bpa-levels-soar?ps=cprs