Friday, 14 April 2017

Second class drugs.

Second class drugs

  The Ministry of Health and its administridiots are not  looking after Canadians the way they should.   They are subjecting us to unnecessary risks to save money, when they may be costing us more as a result of the harm  from ineffective medication.

  I recently had a letter from one of my blog followers complaining that a generic replacement of one of the medications that she had been on for a long time, that had always seemed to be effective was replaced by a generic that not only seemed ineffective, but that actually made her feel worse, due to side-effects that she had never experienced before.  Here is part of her letter:
   "Unfortunately since Teva and other big pharma (but mostly Teva in Canada) has acquired many of our Canadian pharmaceutical companies,many of our generics are no longer made in Canada.  Now they are manufactured in places like India and others. There have been a lot of generic recalls due to poor quality control.  Too much of a dose or too little being delivered and no regulation on what fillers or binding agents are used.  A few years ago in Canada MOST of our generics were made here, but now I believe the quality of some generics is in question and should be investigated further.  I personally have experienced this with two completely different types of medication.  Is this perhaps that they are being manufactured in one of these countries with poor controls.  Health Canada seems to have very lax regulatory standards, the bar is pretty low.  I believe most Canadians are not aware of these changes and assume their medications are still manufactured here..
   Of course the large amount of merger and acquisition activity among the big generic companies has caused this.  Are Big Generic Pharma sacrificing quality and safety  for profits these days?  I think there is a lot of material to cover here.  As an example, the beleaguered Teva is suffering under the weight of it's HUGE debt ,according to the financial experts, and they have had quite a few generic drugs recalled due to poor quality.  Also their CEO stepped down  a couple of weeks ago as he was pressured to resign  and I'm sure there is a lot more to this story."  
   Her allegations are correct; here are some of the facts.
The overwhelming majority of generic drugs are now manufactured abroad, many in India and China. Some Indian pharmacies such as Megafine have been banned from importing to the US, apparently for manipulating the results of required tests.  Forty-five other Indian pharmaceutical and API ( Active Pharmaceutical Ingredients ) manufacturers are currently included on import list alerts and are required to provide evidence of upgrading to meet the standards required by the FDA.  Apparently Health Canada has an even lower bar in screening and arel less restrictive in requiring imported drugs to meet the standard.  Some of these recalled drugs are vital  to  a patient's health and welfare.  Divalproex sodium is an anti-seizure drug (Depakote) the formulation of which was too strong, while a generic heart preparation was not strong enough.  Last year, Dr.Reddy's Laboratories (India) had a major recall of metoprolol, a cardiac drug that many patients are put on after a heart attack.  Their preparation failed to dissolve appropriately.  Other drugs have been recalled, as well as numerous warning letters to companies regarding concerns about their manufacturing process, without actual suspension.  This information is not readily available.
  There are literally hundreds of drug manufacturing companies in India, China, Europe and S.America.  The FDA has very few investigators so it is impossible to thoroughly check even a reasonable cross-section. There have been concerns regarding the Research  organizations testing the products, ranging from outright fraud to incompetence.  GVK Bio-sciences in India conducted many of the studies despite the fact that the World Health Organization discovered major problems with their operation.  Poor as the FDA screening is, Canada's is almost non existent.  Generic drugs are often just as good as the brand names, but before authorizing their use their production and performance must be scrupulously examined.
   Bottom line - the government of Canada is spending extravagantly on all sorts of non essential services.  That money could be directed towards providing safe health care and safe drugs for Canadians.  

Comment if you care! 
Forty-five other Indian pharmaceutical and API manufacturers are currently included on the import alert list, including Ranbaxy, Wockhardt and Ipca Laboratories. - See more at:

Forty-five other Indian pharmaceutical and API manufacturers are currently included on the import alert list, including Ranbaxy, Wockhardt and Ipca Laboratories. - See more at:


  1. Generic and original medications do contain the same active compounds but not the same inactive ingredients and these other ingredients can affect absorption and elimination and can themselves causer side effects. As well there is greater batch to batch variability in a given generic medication. Therefore even the same medication from the same generic company can sometimes be less effective if it is a poor quality batch.
    To be qualified as equivalent to the original medication a generic must be between 80-125% of the original on several parameters. What this means is that the variability between one generic and another can be even greater if one is near 80% and the other near 125%. Pharmacists can change between one generic to another without informing the patient or physician so this can be a real issue.
    For a further discussion of the issues especially as they relate to psychortropic medications please see my paper: Switching from Brand-Name to Generic Psychotropic Medications: A Literature Review. Julie Eve Desmarais, Linda Beauclair & Howard C. Margolese: CNS Neuroscience and Therapeutics 2011; 17:750-760.

    1. Thank you for your comments. When patients complain of the unsatisfactory nature of generic substitutions they are often not taken seriously. I will certainly re-read your article.