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Generic medicines: Spoilt for Choice

Generic medicines: Spoilt for Choice
A legal framework for use of generic drugs is in the offing.
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Prime Minister Modi’s push for these medicines over costlier ones can be successful only if pharmacies, drug controllers and doctors put aside their greed and patients are educated 

~By Kamal Kumar Mahawar in Newcastle-upon-Tyne

The Medical Council of India (MCI) in its ethical code says: “Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs.” Much like many other aspects of this code, the vast majority of doctors ignore this directive too and MCI has neither the resources nor the will to implement its own rules.

However, this particular issue of genetic prescribing has been brought to the forefront by Prime Minister Narendra Modi’s comment: “We will bring in a legal framework by which if a doctor writes a prescription, he has to write in it that it will be enough for patients to buy generic medicine and he need not buy any other medicine.”

So why is there a need to push for generic medicines? What are generic medicines? Every tablet or injection that a doctor prescribes has one or more active ingredient or drug(s) that are responsible for the therapeutic benefit. Each drug has a scientifically agreed name which is not owned by any company—the so-called generic or non-proprietary name.

Depending on how recent a drug it is, there may be a number of companies manufacturing it under different brand (proprietary) names. For some new drugs, still under patent rules, there may be only one brand name available in the market whereas, for some of the commonly used older ones, there might be hundreds!

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Most doctors today would prescribe a certain brand name for any medicine they want to prescribe. There are many reasons for this. The first and the foremost, in the minds of most doctors is the quality of the medicine and like most individuals in other walks of life, doctors trust the popular, visible and multinational brands more. One could argue that it is not strictly the responsibility of doctors to choose a particular brand for a patient as they have no real means of knowing the quality of one brand over another. The responsibility for medicines sold in the market lies with the drug regulator (Central Drugs Standard Control Organisation).

Generic prescribing can only be implemented in conjunction with a major change in the culture of pharmacies… we can transfer the ultimate decision-making to the patient who pays for it all

The second and perhaps more important issue in the Indian context is the mechanism for dispensing these drugs. Let us face it—we treat medicines like grocery items. It is sold by people who could easily be selling crackers and often do. If a doctor was to use the generic name of the drug, who would decide which of the hundreds of available brands should be dispensed and how would chemists (often much less qualified than doctors) know any better?

The biggest advantage of generic prescribing would be to break the doctor-pharma nexus. This would ensure that doctors would be able to prescribe medicines without any conflict of interest solely for the benefit of the patient. Eventually, this would mean that the pharmaceutical industry would be able to reduce its “marketing” and “educational” budget.

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One hopes this will lead to medicines becoming cheaper for patients. It may also reduce unnecessary prescribing and will probably save time that doctors currently spend entertaining medical representatives in their busy clinics. It may also help make the doctor-patient relationship more transparent as the medical practitioners will then not be able to prescribe the same drug under a different brand name.

Transferring decision-making from doctors to pharmacists is likely to make consumers more vulnerable. Photo: UNI
Transferring decision-making from doctors to pharmacists is likely to make consumers more vulnerable. Photo: UNI

More importantly, it may make it difficult for quacks and AYUSH practitioners to prescribe modern allopathic medicine as they might not even know the generic name. There are genuine instances where generic prescribing would be very difficult to implement. This would typically be when a doctor wants to prescribe fixed dose combinations or multiple drugs.

For example, a multivitamin tablet can contain a number of active ingredients and it is impractical to suggest that a doctor has to write all of them. It will only create more confusion. Though we should discourage the use of multiple-drug combinations as they do lead to overtreatment and have little scientific rationale, doctors need to be given some leeway in implementing this and genuine difficulties should be understood.

Let us say from tomorrow, all doctors in India started prescribing medicines using the generic name. Patients will then take this to the pharmacies. In other walks of life, the consumer decides what to buy on the basis of their past experience and marketing sound bytes. But, in this instance, the consumer (patient) would not know how to choose and the pharmacists would, of course, advise the brand name that gives them the maximum profit. Effectively, we would then transfer decision-making from doctors to pharmacists who might prove to be even more vulnerable than our doctors when it comes to self-interest.

It is hard to see how patients would benefit in such an environment. The situation could potentially be much worse off as unlike doctors, pharmacists are not directly responsible for the quality of the care and ultimate outcome. It could further erode the doctor-patient relationship as doctors would then, justifiably, refuse to take responsibility for clinical outcomes.

[vc_custom_heading text=”WAY FORWARD” font_container=”tag:p|font_size:20px|text_align:left” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:700%20bold%20regular%3A700%3Anormal”]

Generic prescribing can only be implemented in conjunction with a major change in the culture of pharmacies across the country. Though it will be difficult and will need a lot of patient education, we can transfer the ultimate decision-making to the person who pays for it all, the patient. The government can work with drug companies to make available ready price comparison sheets for each drug at pharmacies across the country. Patients can then choose which brand of a particular drug they want to buy.

The drug regulator must ensure by intermittent checks and punitive measures, if needed, that medicines on such price comparison sheets meet an adequate quality control standard. This would ensure that the choice of any brand by a patient would not have any bearing on the clinical outcomes.

The biggest advantage of generic prescribing would be to break the doctor-pharma nexus… doctors will prescribe medicines without any conflict of interest solely for the benefit of the patient

Brand manufacturers would provide prices for such a comparison sheet and pharmacies will not be able to charge more (or even less) than the stated price for any brand. This will ensure pharmacists are not able to push brands offering them the highest margins.

Pharmacies could also be asked to stock at least one option from different price brackets for drugs where there are a large number of brand names in the market.

It is also possible that each state will need to come up with its own lists to keep the overall size manageable. Sheets could be updated every third month to ensure prices are up to date.

Another major reform that we need to bring at the pharmacy level is to ensure medicines are only dispensed against the prescription of a registered medical practitioner.

Pharmacies should be asked to keep a record of a doctor’s prescription with his registration number on it. A prescription without a legitimate medical registration number on it should be refused. For long, our pharmacies have treated important medicinal drugs like fruits and vegetables; it is time we put a stop to it.

Overall, generic prescribing is a good move in the right direction and will have several positive ramifications for healthcare in India. However, like everything, successful implementation would require a series of enabling steps at different levels.

The announcement from Prime Minister Modi can hence only be taken as a noble first step.

The writer is Consultant general and bariatric surgeon,
Sunderland Royal Hospital and author of “The Ethical Doctor.”

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