Recently, our PM mooted bringing in a law making it mandatory to prescribe generic drugs. Subsequently, a widely followed Twitter handle expressed apprehension about the return of the Congress/UPA era Control Raj. I’m sure that there are many who share this discomfort with excessive Govt control in various spheres of a citizen’s life.
As a doctor, I would like to make a case, albeit with a heavy heart, for such an advisory or even a regulation. Let’s start with some basic facts. Generic drugs are medicines which contain exactly the same active ingredient as branded drugs, and has the same therapeutic effects. It is exactly the same in dosing, safety, strength, quality, the way it works, the way it is taken, and the way it should be used.
Why, then, are they so much cheaper than branded drugs? Pharma companies spend a lot on R&D to develop new drugs. To protect their investment, they are allowed to market with their new drug under a brand name with patent protection. Once the patent expires, other companies can market their version of the drug. It’s cheaper because the manufacturer doesn’t have to duplicate the original trials for efficacy, safety etc.
With inexpensive yet effective versions of many drugs available why hasn’t their use become widespread? Both, doctors and pharma companies would have to shoulder the blame for that. Doctors, being busy professionals, seldom have time to read about the newer drugs or keep up with the latest research. They are almost entirely dependent on Medical Representatives for their information.
Medical Representatives push their products aggressively and even offer considerable incentives to doctors. Sponsoring medical conferences, doctors’ travel & stay at star hotels, lavish gifts on birthdays/festivals/New Year go a long way in influencing prescriptions. Doctors might refuse actual bribes but who can deny that a company which has sponsored a physician’s trip to Paris for a conference, is counting on maximum brand recall of its products?
There are other, less well known ways of influencing treatment. Pharma companies fund a lot of Medical research without full disclosure. There is an inherent conflict of interest here which goes unnoticed and unquestioned by doctors.
When I graduated 30 years ago, 110mg% was the upper limit of a fasting blood sugar. Now, it’s down to 90 mg%. In one stroke, there are millions of new diabetic patients all on anti-diabetic drugs! So is the case with cholesterol. The upper limit of normal, which used to be 250 mg%, is now 150 mg%. Anyone & everyone above 40 yrs, and cholesterol levels above 150 mg% was put on statins.
The trend is only now being questioned after the side effects of statins have come to light. Similarly, the previous decade saw HRT being used aggressively to treat changes at menopause. Our grandmothers took this change in their stride but thanks to pharma companies, HRT was made the Holy Grail until the possible risk of breast cancer and of developing blood clots caused a rethink.
There are many more such examples where ‘independent’ research, actually funded by pharmaceutical companies from behind the scenes, helps create a huge market for their products. I might add that there is a lot of peer pressure at work here. I might want to tell a patient with high cholesterol to eat sensibly and exercise regularly instead of popping pills. Or a menopausal lady to add milk/curds/cheese to her diet and take a brisk 2-3 km walk everyday. But I run the risk of appearing ignorant/outdated and losing my patient to a colleague who quotes the latest studies in the US and prescribes a long list of new, expensive drugs!
However, failure of generic drugs to take off is not only about a nexus between venal doctors and unscrupulous pharma companies, as the Govt appears to think. There are serious practical issues to grapple with. There have been doubts raised about the quality and efficacy of generic drugs as very few of them undergo quality control tests. This is a genuine concern for doctors wanting to prescribe generic drugs.
Availability is also a major stumbling block. Even if a doctor were to prescribe a generic drug where would a patient get it? Most patients walk into the chemist next to the doctor’s clinic. If the chemist gets a better margin from selling a branded drug, it’s unlikely that he would stock the generic drug.
The Govt has indeed opened Jan Aushadhi stores but they are too few in number and mostly located in Govt hospital premises. Certainly, the numbers are not adequate to cater to the demand. A lack of awareness is another big hurdle. Both, doctors and patients are woefully uninformed about generic drugs and their availability.
The positive point is that a discussion has now begun. If the Govt is serious about bringing in a regulation, it must iron out these problems first. It must standardize generic drugs by subjecting them to stringent quality control. It should make them easily and widely available so that patients are not inconvenienced.
Massive awareness programmes to inform patients about the availability of generic drugs will help to create a demand for them. The IMA (Indian Medical Association), on its part must encourage all practicing doctors to prescribe generic drugs where ever possible. The old MCI (it has been replaced by the National Medical Commission) had notified last year that doctors should prescribe generic drugs and that the prescription should be legible and in capital letters. We must take that up as a mission.
It’s heartbreaking that we might have to be coerced into doing something for the patient’s benefit, which we should have been doing as a matter of course. But I am optimistic that if quality generic drugs are made easily available, we will embrace the change.