A thread on the generic vs patented medicines debate for those not from a medical background. Hence I am simplifying some concepts. Experts please excuse.
Here we go!
Medicines are generally discovered/invented by Pharma companies. The company which first discovers/invents the drug gets a patent (monopoly) to sell the drug for a fixed period of time (usually 15-20 yrs). This is referred to as the patented drug.
Once this period lapses, the patent expires & other companies can now make and sell this drug. These are called as generics For obvious reasons, the generics are cheaper than the patented drug, although the company making the patented drug does usually bring down the price of their brand when the patent expires, for obvious reasons (to compete with the generics).
Now it gets complicated Any company wanting to market a generic drug does not have to do trials to show the drug is effective (which the original company with the patented drug had to do to get a licence). However the generic companies do have to provide evidence that their drug is similar to the patented drug in all characteristics eg. Chemical content, it's bioavailability (meaning how the drug gets absorbed & is available in blood stream to act like the original patented drug).
Once they do this (called bioequivalence in technical terms), the generic drug gets a licence to be marketed. This licence is issued by the regulators eg FDA in US or EU in Europe etc. All these regulators insist on bioequivalence studies so that the generic drug will work as well as the patented drug.
Now the generic company has two options
They can sell their generic drug with a brand name or just sell it with the approved chemical name.
The former are called branded generics and the latter are called just generics (I know, this is extremely confusing).
So what's the problem..?
The problem is the Indian regulators (unlike regulators in rest of the world) do not require bioequivalence studies to be done b4 companies get a licence to sell the drug.
So essentially we have no way of knowing whether the drug being marketed in India has the same quantity, quality, impurities etc when compared to the patented drug.
We have to just rely on the Indian Pharma company's word (with no data) that the generic drug they are selling is as good as the original patented drug.
Almost all the drugs sold in Indian market are generics bcoz very few global Pharma companies sell their patented meds here. Even when they do sell their patented medicines in India (once they go off patent) they sell them with a different brand name to their patented brand.
Now some Indian companies sell their generics with a brand name eg. Rozat (Rosurvastatin) sold by Dr Reddy's. Many of these companies also sell these same medicines abroad, so one is relying on the fact that if their drug is acceptable to global regulators, it must be of good quality. (It's an assumption but too complex to explain why here).
Anyways, you have some hope that companies like Cipla, Dr Reddy's, Sun etc have too much to lose by selling poor quality drugs in Indian market.
Then there are the generics. These are small companies (& there are thousands of them, it's a cottage industry) who sell the drug without a brand name & just the approved chemical name. They usually only sell in the local market. In most if not all instances their quality control is poor or non-existent. So a frequent problem with these drugs is NSQ (not sufficient quantity) meaning if a tablet says 200 mg it does not contain 200 mg. This is a real big problem bcoz you may take the medicine in the prescribed dose, but it does not work bcoz it does not have same quantity of drug.
Drs tend to write branded generics based on (a) trusting a reputed company (b) past experience with the brand quality etc. Detractors say that Drs prescribe a particular brand bcoz they get benefits from the Pharma company.
In response to this, the National Medical Commission says that Drs must only prescribe the approved generic name and not the branded generics.
You are still with me or have I lost you?You do see what the problem is here. It's the Indian regulators. They do not guarantee that the drugs they have licensed to be sold in Indian market are of good quality. Bcoz they do not require bioequivalence (remember that earlier in this thread?)
Basically you are taking a chance that the drug sold in India is of good quality.
When Drs are forced to write only the approved chemical name of the drug (not brand name), it is up to the chemist to give you medicine which may have been made by anyone -including a company based out of someone's garage or kitchen. You see it has not solved the problem - instead of pharma companies chasing Drs, they will now chase chemists to dispense their drugs. Drs are atleast regulated by the NMC, chemists are not regulated by anyone. The chemist is likely to give you the drug made by a company which gives him the best commission & not necessarily the one that has any quality. That would be a business decision. In most instances, it will be a unbranded drug made by the cottage industry company.
Even when your Dr writes a branded drug, there is a certain amount of guesswork about the quality of the drug bcoz the Indian regulators do not require bioequivalence to be proven.
The elephant in the room is actually the Indian regulators doing their job poorly. Why do they not insist on bioequivalence studies which is the best measure of quality for generic medicines is the Q we should be asking.
Of course we all want medicines to be cheap, but not at the cost of quality. After all your life is at stake.
If the Indian regulators only licensed medicines with bioequivalence data and studies, all Drs will have no problem prescribing medicines only by the generic approved name.
But until then, your best hope is to trust your Dr's judgement despite everything.
Thanks for reading.
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