With handbags and shoes you might not care whether you’ve got the real thing, as long as it looks good. But your health is a whole different story. Nobody wants to risk their health by taking cheap medicine.

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In fact, the availability of generic medicines is one of the few truly good-news-stories in a world of constantly rising medical costs.

Are they really as good?
Maybe because they are cheaper, or because the brand-name (or innovator) drug has been on the market for longer, people often mistakenly doubt the quality of generic medicines. Furthermore, some brand-name manufacturers have actively questioned the quality of some of their generic competitors. In a number of cases, the Advertising Standards Authority of South Africa has ruled against advertisements by major pharmaceutical companies that misleadingly created doubt in the minds of consumers regarding the quality and efficacy of generic medicines.

And in a high-profile case from the US, researchers linked to the pharmaceutical company Novartis questioned the bioequivalence of a major generic competitor to one of Novartis's brand-name antipsychotic drugs, Clozaril. Eventually, the US Food a Drug Administration ruled that there was no evidence that the generic drug is any different to the brand-name drug.

Some docs concerned?
Still, some doctors and psychiatrists have expressed doubts over the quality and effectiveness of generic alternatives. We have, for example, learned that the South African Society of Psychiatrists (SASOP) recently convened a task team to look at the use of generic medications in the treatment of psychiatric disorders.

A preliminary statement from SASOP says that a perception has arisen amongst treating psychiatrists that in some cases the generic products are not as efficacious and cost-effective as the innovator products. "This is due to observations of relapses or lack of response to treatment when some patients are ‘switched’ to generic medicines, or even when they are used as the first option in treatment.

“There also seem to be similar perceptions in the minds of the consumers (patients) who choose to use generic drugs as first line treatment, or switch to them at the insistence of their medical aids, or due to financial constraints, and experience them as being less effective or not effective at all," the statement said.

SASOP is, however, still investigating the matter and a position statement is expected toward the end of the year.

Apart from anecdotal evidence, SASOP did not offer any published research to back up their concerns. And it should be noted that SASOP and their activities are in part funded by the pharmaceutical industry.

Why generics are safe
The reality is that generic medicines are by law subject to the same strict regulations and approval processes as brand-name drugs and must meet the same standards of good manufacturing practice (GMP). The mere fact that the Medicines Control Council (MCC) has allowed the generic medication onto the market should offer you all the reassurance you need to know that you are not getting an inferior product.

It is, for example, worth pointing out that Aspen Pharmacare (South Africa's biggest producer of generic drugs) has manufacturing facilities accredited by the US Food and Drug Administration.

Tough criteria
"A drug is only registered in South Africa if it meets MCC criteria," says Professor Peter Eagles, chairman of the MCC. "Our aim is to ensure that each generic drug mirrors the patented drug."

According to Eagles, particular attention is paid to the bio-equivalency of drugs with a narrow therapeutic index, where small differences in the amount of active ingredient absorbed into the body can result in dramatic reactions to the drug.

"If a product isn’t absorbed in a completely predictable fashion, we’ll look at it very carefully," he says.

He adds that the public should be informed about the generic equivalent to patent drugs at their pharmacy and other dispensing points, and that the use of generics should be vigorously encouraged.

Why are generic medicines cheaper?
Generics become possible when patents expire. The research and development of a new drug may total billions, and they are patented to give their developing company a period of exclusivity in which to recoup some of those costs. Brand-name drugs are generally given patent protection for as long as 20 years from the date of submission of the patent. When that protection expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the MCC.

As soon as generics are introduced, the brand-name drug looses its monopoly and normal market forces tend to drive down prices significantly.

Less defensible (though a market reality), though, is the fact that brand-name drugs can sell for more due to brand loyalty and a distrust of generic alternatives.

How are generic medicines different?
In terms of the active ingredient, generic drugs are no different to brand-name drugs. Whether 7-chloro-1-methyl-5-phenyl-1, 3-dihydro-2H-1, 4-benzodiazepin-2-one is called Valium (the brand-name) or diazepam (the generic name), it is still 7-chloro-1-methyl-5-phenyl-1, 3-dihydro-2H-1, 4-benzodiazepin-2-one.

The MCC requires that a generic drug deliver the same amount of the same active ingredients into the bloodstream at the same rate – and they’re very strict about this requirement.

The only differences between a brand-name and a generic drug are the inactive ingredients (preservatives, colourants and compounds to hold the medicine together), which is why the colour and flavour of generic drugs and their brand-name counterparts may differ.

- (Marcus Low, Health24. September 2008)

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	Funny thing 2008/09/08 01:23:06 PM The funny thing is that there is absolutely no diference between an originator drug and a generic once the patent expires. The branding may look diferent, but that is all. Still, it is amazing how well originator drugs are selling given the cost of health care. - Zac   Good pharmacists 2008/09/08 03:18:23 PM I' m lucky - I have such a great pharmacy - they will always tell me the generic options on all meds and they' ve saved me a lot over the years. - aNNa   Moral 2008/09/08 03:48:34 PM I think doctors or pharmacists who do not tell their patients about the generic alternatives are morally corrupt. - Peter   Really??? 2008/09/08 05:01:02 PM If all generics are equal to the originator product, why are there a number of original products that our own Medicines Control Council have put out a list telling pharmacists that these drugs may not be replaced by a generic. I can only assume that the generic is not as good as the original. Secondly, the excipiennts such as binders, colurants preservatives, lubricants, etc added to a medicine can affect the effectiveness of the product. Cheap and nasty can still be cheap and nasty!!!! - Pharmacist   RE: Good pharmacists 2008/09/08 05:05:57 PM It is not that you have such a good pharmacist, they are required by law to offer you a generic if this is available. If not, they are not complying with the law. - GE   look... 2008/09/08 05:29:33 PM Generics might be the pharmacological equivalent of the original medicine, but the way some manufacturers design the tablet might differ.Lets take Tylenol,the original paracetamol and compare that with a generic.Some generic paracetamols might release the full 500mg while another tablet from a different batch made by the same supplier might only release 300mg.It all comes down to the design even though the ingredients are the same - Pop Idol   mostly good, but not always 2008/09/08 05:33:27 PM My husband was put on his medication and the doc wrote ' no substitutes'  on the script. The pharmacist then convinced him that since they don' t stock the original the generic is just as good. Unfortunately, with his set of illnesses the generic caused him to become suicidally depressed, which is why the doctor said no subs. So just remember to ask your doctor first. - Melanie   blind trust 2008/09/08 07:56:54 PM Standards of generic manufacturing can differ widely, and many of the generics sold in SA are manufactured in countries such as India. There have already been numerous documented incidents, where different batches of the same generic have been found to have different doses of active agent, as well as different exipients. I spend a little more, for the peace of mind an original drug provides - KP   Not always the truth 2008/09/08 10:43:10 PM The above article sounds nice, but reality is in many cases different. My wife, for example, changed to a generic for her high blood pressure problem. After a few days the generics were thrown into the dustbin because the side effects were much more severe. We will not just take a generic - first maybe take them for a few days and test them. Only after that we " may"  take it. I don' t trust some of the overseas manufacturers. - Wolfgang   Not 100% same always 2008/09/09 07:45:00 AM A popular stomach ailment medication had a generic. Due to certain manufacturing differences the generic actually became ' cement'  on the bottom of the bottel. This actually caused the death of some infants as all the shaking in the world could not dislodge the actual medication on the bottom. Do you think it is the same as the original? As most of us is not in health professions we do not know which generics is safe or not? Yes - original is more expensive but what is the price of life? - Annie Dreyer   Originals 2008/09/09 09:24:13 AM Of course we should keep in mind that original drugs also often causes side-effects and that there is also quite often bad batches of original medicines. The thing is just that when there is a problem with a generic we say, ah it is a generic. When there is a problem with an original we just accept it. Bottom line though, both generics and originals face the same tough regulations etc. I challenge anyone who claims that a certain generic is sub-standard to report it to the MCC, - John D   NO WAY!! 2008/09/09 09:49:16 AM After 25 years of being severely clinically depressed, I was prescribed the anti-depressent Effexor (225mg) which has given me the gift of a normal life. I have to pay in a ludicrous amount each month since my medical aid only covers the generic in full, but rather that than end up in hospital like one of my psychiatrist' s other patients who opted for the generic. I do not care what any " standards"  say - the proof is in the pudding. - Sufferer   wNnonaNk 2008/09/22 12:46:57 PM arvpIr - LePZtDmAHzpUxYA   not the same 2008/10/10 11:44:10 AM in the treatment of my children i realize the difference between the two, the healing time seem to be faster and more effective. i cannot explain it and yet i cannot afford the real mccoy i have to buy generic.i know goverment mean well.so i give them the generic form and pray for the best - gambit
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