Monday, May 05, 2008

WHAT ABOUT GENERIC DRUGS?

Over the weekend, on Sunday, I was invited to chair a CME meeting, organised by PMPASKL, and sponsored by a company called, Glenmark. In preparation, I went into the Google search engine and found that Glenmarks, is an Indian company that manufactures generic drugs. They have factories in India ( HQ ), Czech republic and also Brazil. They seem to have done some clinical testing work, doing bio-equivalence study. Being a " generic " company, they are copying other "patented" company products to market, and also " borrowing " the patented company's clinical trial results as their own. For this particular sunday night dinner meeting, the product from Glenmarks being highlighted was perigard, a generic drug for treatment of hypertension, mimicking the effect of one of Servier's product called Coversyl or Peridopril. Of course the speaker highlighted the usefulness, and safety of Perindopril as evidence in the many trials that Servier had conducted. Coversyl ( the product from Servier ) is actually, perindopril ester which is broken down in the liver to the active metabolite of Perindoprilat. Perigard ( the product from Glenmark ) is actually perindopril erbumine. Is perindopril erbumine equivalent to perindopril ester? will it have the same safety and efficacy, as evidence in the many trials done by Servier? I am just using Glenmarks ( perigard ) and Servier ( Coversyl ) as examples. With the rising cost of healthcare, MCOs are cutting down cost by resorting to the use of generics. Besides the issue of bio-equivalence between the patented product and the " look alike ", what about the issue of quality control? It would appear that Glenmark, together with many of the larger generic companies, are beginning to market and brand themselves, by sponsoring clinical research and even CMEs on their product. Soon, we may all be force to use some generics, and soon the generics will be so well branded that we cannot easily tell the difference. I struggle with this possibility for a weekend, and resolved that perhaps there are generics and there are generics. Perhaps we should learn to differentiate generics from first world countries as oppose to generics fro 3rd world countries. The former, with some semblance of quality control and clinical research and the latter with poor quality control standards and no clinical research. If 1st world generic companies have good quality control and conduct large scale clinical trials, then their cost will no longer be low, and they will have little cost advantage over the patented products. In fact, I am told that many large MNC with patented drugs are resorting to generic drug production to fight generic drug companies at their own game of cost. Well things are getting more confusing and complicated. Should we tell the patients, what we are prescribing to them?

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