Tuesday, August 7, 2012

I love generic drugs too...But…

Generic drug name: any drug which is called by its chemical/pharmaceutical name. like Paracetamol or Chlorpherniramine Maleate or diphenhydramine.

Specific drug name: the names people buy medicine in pharmacies like – Crocin or Calpol or Avil or Benadryl…or whatever name you remember from the prescription your doctor wrote last time for you.

Now lets start with a little story. Lets imagine that you are a top level recruiter for a big MNC and tasked with hiring people for your company. You schedule interviews with two colleges as part of their campus placement programs. On further investigation you learn that college A had during its examinations allowed its students mass copying with absolutely no supervision, while college B had strict standards in-house and there were roving squads which debarred anyone found copying. So you cancel that interview at college A and recruit exclusively from college B- noted for its fairness and strict vigilance. Meanwhile, College A calls you up, insists that you recruit from their students too- as a Degree is just a degree- no matter how acquired and their students have equivalent degrees to the other college too- regardless of how they got it.

Will you accept this explanation? That a degree is just a degree from wherever got? Even if the invigilators were fast asleep during the exam? The degree has still got value? 

And this is the question which arises on my mind whenever there is talk in the media about the value of generic drugs, courtesy a new found interest on healthcare by our esteemed parliamentarians focused by a shall-be-unnamed actor’s TV show.  Madam Sushma Swaraj has made a statement in Parliament (of all places) that if generic drugs can be prescribed successfully in America, why not in India?

And hence the above example - although I don’t expect Sushma Swaraj to ever visit my blog to read this.

The recruiter in the above example is you and me- the general public. The college A where rules are disregarded and no supervision takes place is India and the college B where the college authorities are vigilant is, you guessed it, America. And telling us that if  generic drug sytem works in America, so it should work in india, is like telling us all that only the degree printed on paper matters and not the fact of “how” it was obtained. And that is the sad, but real fact of the pharmaceutical industry in India and especially the regulators- the drug control bureaucracy system which is comatose when compared to the Amercian FDA- food and drugs agency. 

The FDA kicks ass- no second thoughts on it. They take their job seriously. They investigate, analyse, and even hound the pharmaceutical companies sometimes, till they are satisfied absolutely satisfied that a given drug on the market is safe. When pharmaceuticals complain that it takes around 10 years to launch a new drug on the market, even after passing all the safety standards for laboratory products, it’s the role of the FDA they are talking about. The pharma companies say that it drives the prices of the drugs up- for adding to the development costs (and the salaries of the scientists involved), they end up paying for the long periods of testing involved to get the approval with no chance of any profit yet- which sounds a reasonable gripe. But. The FDA always errs on the side of caution- doing its due diligence- and protecting the American consumer. And banning drugs when necessary. 

We in India follow the FDA guidelines too- secretly- when the FDA red flags a medicine- most doctors in India stop prescribing it – even though it may still be available freely on the market. Two examples- think Nimesulide- a pain killer/antifever drug (what we call an analgesic/antipyretic)- banned for causing liver failure in the USA- but still prescribed by some doctors in India- because its still available in the market, freely for prescribing to anyone- including children. (courtesy a high court judgement for not giving prior notice to the manufacturing drug companies before banning - a minor loophole exploited by the company).

 And think Cisapride-an flatulent/motility agent- used for bowel cleaning- and linked to heart disease. Would you rather have a little gas or an heart-attack?
Or Baralgin? Taken by many women for easing their menstrual cramps? But banned since the 1970’s in America for causing dangerous skin eruptions which can be life threatening?

I can go on and on, giving examples of lax regulatory control in India compared to the USA. So saying that works in America should work in India is like comparing apples to oranges, Madam.Sushma Swaraj. Democracy works very well in America does it work even half as well in India? Does public probity?

Anyway to get back to the premise of the article, the reason we can’t trust the quality of the generic brands available in your neighbourhood medical shop is because you can’t trust most medicines in your neighbourhood medical shops. Adulterated drugs are rampant. And when you take away the power of doctors to prescribe a particular drug from a particular company and pass the power to the man handling the sales department at the pharma shop, you are taking a great risk with the lives of the people. 

The way generic prescribing works is like this. If a doctor wants to prescribe a vitamin tablet for you- say B12...he writes his prescription for Vit.B12 and hands it over to you (under the generic drugs scheme) to take it to your local medical shop and get it. The medical shop is supposed to stock the vitamin in its generic or unbranded form, mass manufactured according to the cheapest quotation available and supplied to the government by tender. The medical shop salesman who suddenly becomes the authority to decide what medicine you buy is under no obligation to sell you the cheap generic drug. What profit is there for him in that? The medical shop salesman will naturally sell you the same medicine in its branded form- depending on whichever drug company offers him a better margin of profit (say 20% compared to 8%). 

This already happens- I don’t deny- as the medical shop people sometimes for example, substitute becousles tablet when a doctor writes the cheaper nutrolin-b tablet (even though the same VitB12), but at least now when the patient returns with the medicine to the doctor to cross check it, the doctor can find out and blast the medical shop personnel for changing his prescription without authority. When it’s a generic prescription the doctor loses his hold on the drug name prescribed and the medical shop man takes over. He is under absolutely no compulsion to sell the generic medicine- who is to bell the cat?

My Next Point is that sometimes certain drugs are available in certain specific combinations from certain manufacturers only. After all, they know about generic drugs too don’t they? And so if they need to stand apart from the crowd of companies all making the same medicine-like the popular painkiller Diclofenac  (Voveran?) they have to innovate to differentiate. This actually works out well for the general public too. For instance the same diclofenac – which is used as a pain killer- is produced as a sodium salt by most companies. But it has a side effect of causing acidity in the stomach. So a few companies have produced the potassium salt version of diclofenac- enteric coated tabs- which means it doesn’t get digested in the stomach and cause acidity there, but it travels in a un-dissolved form into your intestines where it gets dissolved and then gets absorbed into the blood and acts on the pain elsewhere. Now wouldn’t you say this is a useful thing to have? For someone who has great muscular pain due to a sprain or an injury, but also unable to take painkillers due to acidity problems this would help. 

Unfortunately, you won’t get his kind of specialized drugs in the generic market, which focus on manufacturing only the basic form of the drug for the mass market.

And one further point is when you use branded medicines you can be reasonably sure of the quality that you are getting, because the company which has its own reputation at stake does a far better job than the govt drug control people in finding out and destroying any fake products carrying its brand name. 

So, finally it all boils down to this, can the government improve its monitoring mechanism? Can it guarantee the safety of the medicine being sold in the medical shops?  If it can, then I am all for generic drugs too, but till we get that infallible belief, it would be better to let both generic and branded medicines co-exist.

After all when you have a sick child crying with fever, you wouldn’t want your doctor to hesitate which medicine to write, would you? Or whether it will work at all? That kind of dilemma shoud’nt be there in medicine- not for doctors and not for patients.

(P.S. I am not in any way Anti-pharma industry. I do believe they support medical research far more than the govt does. Name any new drug which came out of any govt sponsored laboratory? But because of the long periods of time involved in drug development – some pharma companies try to get back their profits in a very short term and have steep prices rather than pricing it moderately and getting benefits over the long term. And that’s where they end up getting all this bad press and also patent violations by govt’s citing public interest. Short term greed.)

(P.P.S. at one point in my life/career all I wanted to do was research and to find out novel medicines for life threatening diseases- but I have been cured off that illusion now. The only way I will get back to research now is- maybe if I get to marry a rich heiress, who will sponsor me financially, I can establish my own lab and invent new medicines)


  1. Ganesh, I really really enjoyed reading this post. I wish the certain actor who shall remain unnamed had not oversimplified issues so much on his popular rabble-rousing TV show. Generic drugs are not some magical thing that doctors or the government has been with-holding from the public so big pharmas can profit.

    I mean, in our municipal system, we purchase both generic drugs - like paracetamol, amoxycillin etc. to stock in the pharmacy but as you said, sometimes certain combinations or a particular salt can only be prescribed as a branded drug because of the particular pharma that produces it.

    I think this system comes closest to the ideal as far as our country goes - so yes, you're perfectly correct when you say both must co-exist.

    I wish that TV show had not painted doctors out to be some money-mongering monsters who care two hoots for a patient's health and are just after earning profits. That's so far from the truth that it's laughable. We really think things through before we prescribe something. But, in all honesty, I really don't want to wonder if the drug I prescribe will actually work on my patient before I get down to writing its name.

    That would really suck!

    As for nimesulide still being freely available in the market, now that's the kind of thing that a genuine TV show could have highlighted - things that stay under the radar but can be much more dangerous than shelling out eighty or so bucks extra for a strip of meds. But well, that's a rant for another day.

    1. thanks Tangled....and yes..i felt its better to leave the actor out of it altogether rather than dignify his assault on doctors...just for a few TRP's. and i was not really surprised to see the politicians jumping on his bandwagon tryin to get their two minutes of soundbytes/limelight. Doctors are part of society too? is it fair to hold us to a different standard? rather than say lawyers? are there any discussions you have heard of anywhere in the media about how much lawyers make and why they should reduce their fees? don't doctors have families and school going kids and financial needs too? and not all doctors mint money - as portrayed in the show....by the time we finish out PG/Post-PG - most of us are in our thirties and then we are newbies to practice..most doctors start seeing real money only in their fifties...so to pick on them, just because they seem successful is a real shortsighted thing to do...as it is, so many medical seats are going free..because kids nowadays are smart and opt for engineering/IT jobs...and with all this negative publicity, who could blame them?

      p.s. and i would love to read your "rant" on banned drugs...soo looking forward to it..do get to it soon?

  2. On the flip side, the US FDA is not only terribly slow in approving certain drugs, it is also notoriously corrupt. In the 1980s, a researcher at my former university warned about the possibility of sugar substitute Aspartame causing brain aneurysms, a warning that was not only ignored, the FDA under Bill Clinton actually hired a "scientist" who had worked on the development of Aspartame and certified it safe. For more than ten years people were subject to what was possibly a dangerous chemical because of this corruption.

    There was also the brouhaha over the plastic additive BPA (Bisphenol-A) which the FDA certified as safe for use in microwavable plastic containers. When the Canadian regulatory authorities found that BPA caused some dangerous endocrine conditions, DOW Chemicals, manufacturers of BPA in the USA, used the FDA approval for their product as an excuse to sue the Canadian government. They had to retreat tail between their legs when the EU confirmed the Canadians' research.

    More recently, we have the approval that the FDA has granted to the sugar substitute Stevia - Canada and the EU warn that it might cause testicular cancer in some men. It is still legal in the USA. The farce continues . . .

    If India wants to be careful about its drug approval policy, it should look at Canada and Europe instead of the USA. In both Canada and in the EU bureaucracy, the regulatory and testing processes for food and pharmaceutical formulations are much more proactive and stringent. The USA is not an ideal example to look at as far as pharmaceutical regulation is concerned - anymore.

    1. after your heads-up...i have been reading up on the artificial sweetener thing Mehul...and i find too much claims/counter-claims...contradictory opinions masquerading as unbiased scientific opinions..so it would be better to err on the side of caution and avoid aspartame i guess...anyhow, what i was trying to get off my chest was..blindly aping the americans without putting in place an effective safeguard like they take for granted is a sure shot recipe for disaster when it comes to Indian conditions. i wish they would follow the more stringent European guidelines, but its not going to happen anytime soon, is it? we have too much pride in doing things the "indian" way..even if we doing it wrong...

  3. Have you considered sending this one for the Hindu open page? please do!

    1. hmm!! letters to the editor? not exactly my idea of fun....maybe afet i retire sindu and have nothing else to do...

  4. Excellent blog very nice and unique information related to generic drugs. Thanks for sharing this information.