INDIAN DOCTOR, INDIAN PATIENTS & GENERICS: A TRIO OR OPPONENTS

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ABOUT AUTHORS
S.P.Sethy*, Tahseen Sameena, Prathima Patil
Department Of Pharmaceutical Chemistry,
Sushrut Institute of Pharmacy,
Medak, Andhra Pradesh, India
*sarada9439504350@gmail.com

ABSTRACT
This is a review aimed towards the current scenario of health care system in India with respect to the approach of Indian doctors towards the use of generics for a convenient and cost effective healthcare which is a major concern for all Indian citizens and this scenario should get clear for the betterment of Indian patient and the overall healthcare scenario in India. We can say the health care system is four tare system consisting doctors, patients, pharmacist and medicines, so there is a need to establish a significant relation between these four systems for a better health care facility in the country. In this review we have analyzed the Indian doctor’s perception status towards generic medicines, a patient’s feedback status towards generic medicines and from the side of pharmacist in dispensing generics medicines in India. We found that a major part of this system is running out of track and if it remains unsolved an Indian patient can’t expect a cost effective and efficient health services in future

INTRODUCTION:
India is a developing country with approximate population strength of 1.25 billion with a GDP of 1.842 trillion (2012). We are now spending 2.45% of GDP for public health care and we know that as far as the population and economic status of the Indian people is concerned this much GDP towards health care is not sufficient to provide a better health care for Indian people. If we compare the % OF GDP invested by other developing countries like Thailand, Malaysia Srilaanka with India, we will find that we are providing an insufficient GDP towards healthcare services. In a country like India where we find people with wide economic variation one cannot expect a uniform health care service to all peoples. But if we see the health care services of other developing and developed countries we will find a uniform healthcare services to all people as the and the government of  these countries is taking strong steps to maintain a sound healthcare services to all. But it is not correct to say that Indian government is doing nothing towards improving the public healthcare service. But still the health care services in India are not up to the mark that what it should be. If we try to find out reasons behind this issue we will get many set back in our system. But honestly speaking, what the initiatives are taken by the government of India health and family welfare are not implemented correctly throughout the country. So many non government organization and health care professionals are currently working in this field to provide a cost effective healthcare to the Indian patients but they are still struggling for the complete success. If we completely scan the health care system in India we will find many loose points in the systems which are interlinked to each other. The major setback of our healthcare systems are as follows

THE BLACK FACE OF GENERICS:
Doctors, the principal element of the healthcare system is like a sun and patients, pharmacist and medicines are like planets revolving around them. Healthcare system will be effective when there is a proper command of doctors over the pharmacists, patients and medicines. The nexus between the four systems should go in an ethical way i.e. the all the components of the system should think in favor of each other not against each other. Then only we will find a cost effective and efficient healthcare service in the country. But Let’s come to the actual scenario of healthcare service In India, we will find much evidence which is not only serious but also unethical.

Coming to the first point if an Indian doctor think in a way that he/she will always try to give such a service to the patient which will not only cost effective but also efficient, one best option in his/her hand is the intelligent use of generic and branded medicines in his/her prescriptions. Generic medicines not only have the capacity to reduce the cost of prescriptions but also have the strength to give a better therapeutic efficacy as compared to the branded drug. But a question arises here is, does Indian doctors have faith on generic medicines? During our research on this topic we found opinions of various Indian doctors and from there opinion one thing came to the front that Indian doctors are losing faith on generics medicines. This is not a good sign for patients and the generic pharmaceutical firms.

There are various reasons behind disbelieve towards the use of generics. One of the major reasons is the difference in the bioavailability between the generic drugs and the brand name drugs, generally the generic drugs shows improper bioavailability as compared to the branded drugs if bioavailability difference is there then the disease will not cure and a higher therapeutic dose and frequent medication is required, which is a poor therapeutic approach. Doctors always do experiments with different types of medicines (both on generics and branded) on patients during their practice period, when a doctor observes that after repeated use of generic medicines it is not showing a proper response in a patients in more than one trial in that case the doctor automatically switch to branded medicines and the doctors are getting good results out of it. So this is the reason why doctor now a day’s switching more to the branded drugs that the generics.

The prime idea behind the concept of generic medicines was to reduce the medicine cost and to avail the same therapeutic activity as shown by the branded medicines i.e. when the generic copy of a patented drug releases the bioequivalence study is generally carried out to ensure the therapeutic equivalence between the two forms of the same molecules. But the actual practice is not vivid. We will observe a wide range of price difference between same drugs manufactured by different manufactures. Some manufacturers are selling the generic drug at high prices where as some selling the same drug at a very low price. These price differences are putting a question mark in the mind of doctors that which one they will choose the high price or the low price version of the drug.  But as far as the concept of generic drug is concerned price should never set the quality of drugs, that means whenever a patient will purchase a high price or low price version of same drug he or she should get the same therapeutic efficacy. And if a patient will get the better therapeutic efficacy from a very low price version of a drug then why he/she will think about purchasing the high price version of the same drug. But the question arises here is can a doctor or patient keep his/her faith on low price generics and what is going to be the effect of low price generics on patients health

We think the most appropriate answer is neither the doctor nor the patient can keep their faith on low price generics when it the question about a patient’s life, nobody will think about taking a risk. Let’s think on a point that what is the main cause behind the wide price variation between the same forms of a drug from two different manufactures? Is it just a marketing strategy or there is any manipulation in the formulation is there? A general concept will come to our mind that how a pharmaceutical firm can give a drug at a very low price where as his competitors is manufacturing the same drug at relatively medium to high price. Some questions to be discussed over here are when a Pharmaceutical firm releases a low price generic drug, Does the firm is following the correct manufacturing process? Does the firm is using the correct exipients? Does the firm is putting the right amount of active ingredients? And what about the quality of the active ingredients? And what about the level of quality control quality assurance? If we analyze the question we will find many of these above of the systems  can be bi passed in the manufacturing of  generic drugs which can leads to the create bioavailability problem.

Some generic pharmaceutical firms are manipulating their product because they have to survive in the cut throat competition in the market and by bypassing one the above step can reduce the price easily and they can avail their product at a cheaper rate compared to other manufacturer. It a serious offence and this type of unethical drug manufacturing practice should be checked by the drug control authority to safeguard the trust of doctors and patients towards generics.

THE PHARMA- DOCTOR NEXUS:
If we see the pharmaceutical marketing strategies we will find that a pharmaceutical firm generally adopts many ways for their product promotion like electronic media, through medical representative etc. The only strong and effective way of interaction between the doctor and medicines is only possible by the medicine representative. But a problem arises here is that so many pharmaceutical companies are there and a doctor generally interacts with countless representatives per day. In this situation it is very difficult for a pharmaceutical firm to ensure that weather my product is in the mind of the doctor or not, so in this situation some firms are adopting unethical marketing strategies. Unethical in the sense there is a nexus between the doctors and the Pharma firms for their own benefits. The business development executive usually gives mouthwatering offers to the doctors to get their product on the prescription. Some doctors from their side also responding to this type of offers , and as a result of which patients suffers as he/ she has to buy the medicines of that particular company which is on the prescription. In this situation the doctor kept himself aside in thinking about the patient’s benefit. This type of unprofessionalism should be checked from doctor’s side and from the side of pharmaceutical firms also. Both should maintain standard in their respective fields to make the healthcare scenario favorable towards patients.

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THE DUAL FACE: UNBRANDED GENERICS AND BRANDED GENERICS
India is the largest manufacturer of generic drugs. Around 20% of world’s generics manufactured in India by approx 1500+ pharmaceutical firms. A generic drug should always manufacture and marketed in its chemical name only. For example Paracetamol 500 mg, ibuprofen 400 mg. If the entire pharmaceutical firm follow this rule and send all the drugs in their generic name only there will be difficulty in product identification i.e. which drug belongs to which pharmaceutical firm. So to avoid this type of confusion pharmaceutical firms usually likes to give a brand name to their product for ease of identification and promotion of their product, for example calpol and crocine is the brand name for the generic drug “paracetamol” by two different pharmaceutical firms. In this case the generic drug paracetamol with a brand name is called as branded generics. Usually branded generics enjoys high price compared to its pure generic version as pharmaceutical firms usually go for their product advertisement in electronic media. Some firms are there they don’t want to put any brand names on their product and they simply send their product with the chemical name only.

Now here a price and quality conflict between the generics and branded generics. Here the pharmaceutical firm has modified the concept of generics for its benefits. Now what is going to be a doctor’s perception towards the pure generics and branded generics? And what about the patient’s perception towards these two form of generics? And what about the cost of the prescription? And again there will be a issue of therapeutic efficacy between generics and branded generics. Once again doctor and patients in a confusion that which way they have to go. 

THE DOCTOR’S REPUTATION: This is an interesting issue as every doctor likes be a good doctor. Good in the sense of cost effective and efficacious patient care. Always a patient likes to visit doctors which can cure his disease in minimum visit. Doctors from their side also try to give their best to their patients. So in order to make a good reputation in front of the patients doctors usually forgets one thing i.e. the cost effectiveness in patient care. The reason behind is doctors now a day prescribing more branded drugs than generic drugs as they don’t have trust on generics ,as a result of this the cost of the prescription increases. No doctors want to put their reputation unnecessarily at risk by prescribing the generics only. So a doctor’s reputation is putting a economic burden on the patients. Now the question is which way a doctor will think, for its own reputation or for a cost effective patient care?    

SHOULD THE DOCTOR  HAVE TO LISTENED A PATIENCE? : Few years back Ministry of health and family welfare Government of India Initiated a public awareness that “Patients should ask the doctors to prescribe drugs which are efficacious and that should be of low price”. This is a very good thinking by the health ministry but the question is can a patient has the right to ask to the doctor about cost- effective medicines? or can a patient dare to ask like that? Or the doctor should always think for prescribing the drugs which are efficacious at lower cost. We think the doctor should take the initiative first before the patient do. But this is not happening in practice. As many Indian patients don’t like to interact much with the doctor due to busy schedules and a doctor also usually never show any interest in the financial background of the patient. In this way there is always a communication gap remains b/w the Indian doctor and Indian patient.

ECONOMIC BACKGROUND OF INDIAN PATIENTS: When an Indian patient make a visit to the doctor during that time many thing come to his/her mind. One major thing is what is going to be the cost of prescription, this thing going to be more complicated when the patient belongs to an economically backward category. In India where many people are still struggling for their basic needs in this situation a health problem will definitely going to put additional economic burden to a patent. When A doctor prescribes a prescription to  patient, he/she never want to know about the financial background of the patient in this situation many question arises i.e. whatever the medicines are there in the prescription, does that patient is capable of purchasing the total medicines?. And what is going to happen the when the patient fails to by the total medicines. And what about the disease, is it going to cure?

During our research on this topic we took opinions of different patients from economically backward ground and the data we got was really disappointing. Generally when the total cost of the medicine goes out of budget for a patient he/she likes  to choose a alternative way  i.e. dose reduction  because he/she can’t purchase the complete dose due to lack of money. A question arise here is what will happen when a patient will take half medication? Definitely the disease will not cure. So the economic factor of the patient is going against him, and the prime reason is due to the use of branded medication in the prescription ultimately hike the prescription cost.

Till now we have discussed about various aspect of health care issue connected to doctors, patient and the use of generic medicines by Indian doctors. In India there are many health care programmers initiated by the health and family welfare department for the general public health, but the system is not working properly. Somewhere something is lagging behind, lack of a strong administration in all the department of our health care system, lack of sound FDA in India, and a lack of doctor’s interest in a cost-effective treatment, the third reason is partially true as we can’t blame all the doctors for the health care issue. We also collect opinions of doctors working in government and private organizations and from their opinion one thing is clear that majority of doctors are trying their best to give a cost effective and efficacious healthcare to their patients but some problems are there in the system which are going against and it is diverting their thinking for a cost effective health care. The setbacks are as follows.

1. Doctors in India are already prescribing generic drugs, but through their brand names. If the authorities want us to prescribe drugs through chemical names, why do they allow so many brand names and why are there such wide price variations.
2. According to a doctors view suggestion to prescribe drugs without their brand names leaves the decision of which drugs to sail at the hand of pharmacist. But this will definitely create potentially jeopardizing patient care.
3. Another disappointing news is the occurrence of counterfeit generic drugs. India’s health ministry told the Indian parliament that of 48,082 samples of drugs tested in 2011 by government drug regulators, 2186 (4.5%) had been found to be of substandard quality.
4. A vital problem with generics is the “quality”. This is the main reason why doctors are losing faith on it. The first step should be to ensure quality standards, quality monitoring, and quality assurance unless doctors become convinced. There is uniform quality, independent of the source of the compound; I don’t expect doctors in India will routinely write out prescriptions with chemical names of drugs

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The above issues show a way full of doubts towards the use of generics in the prescription.  Now a day’s Doctors need a clear cut scenario for generics so that they can prescribe the generics without any hesitation. In countries like USA and UK where the 70% of the prescription drugs belongs to generic class because the doctors over there have strong faith on generics. One prime reason behind their strong faith is thy have a strong food and drug administration which can ensure that whatever the indigenous and marketed generics available are of standard quality and it provides a hope for the doctors to blindly trust on generics in their countries and the patients are getting cost-effective healthcare services. Though we have our food and drug administration stills they failed to ensure the quality of generics. In India we have many examples where serious health hazards occur due to the use of drugs (specifically some sub standard generics) and as a result of which doctors get convicted. So this makes Indian doctor’s prescription out of generics in most of the cases.

So there is still to work more on the generics to get the faith back towards generics. The first and for most thing to work on generics is to ensure the “quality” of generics. This can be ensured by the strong actions of Indian drug control authority and the quality assurance department of the respected pharmaceutical firm. As we are always promoting the use of generic drugs so in this situation quality should be the prime factor to consider and this can again bring back the faith of doctors towards generics.

Another ambiguity related to generics is the wide range of price variation in generics version of a same drug manufactured by different pharmaceutical firms for example 10 tablets of unbranded cetirizine, a second-generation antihistamine, were available in 2012 for about 1.50 rupees (pound 0.017; euro 0.019; usd 0.025), while a branded generic product was sold at 27 rupees, and a branded version cost 39 rupees. So in this case a doctor will choose which one?. Another question is does the cetrizine having cost 1.50/10 tabs is therapeutically equivalent to the cetrizine having cost 27/tabs? If yes so why the doctors are not choosing the lower price version of cetrizine and if the answer is no then why the low price version is there in the market?  Can doctor trust for low price version of a drug at the same time the high price version is available in the market? Many things to be clear over here to get generics back to track.

MCI In its directive dated January 21 to the principals of medical colleges, director of hospitals and presidents of all state medical councils, the MCI has said that every physician should, as far as possible, prescribe drugs with generic names and ensure that there is a rational prescription and use of drugs. All doctors registered under the MCI act have been asked to comply with the directive. If doctors will prescribe the medicines in their generic names only then it will definitely open a new option for the patient to choose the medicines of its own choice which was not possible in case of branded prescribing where a patient has to purchase medicines of doctor’s interest. Generic prescribing helps the doctors to keep themselves aside and they let the patent to interact with the pharmacist for their medication. Here can we say that the interaction between the patient and pharmacist will give a better result or the problem will go worse? Here generic prescribing can create two consequences, one is generic prescribing opens up a new option for the patients to choose the drug of its own choice i.e. he/she can choose the medicines of any pharmaceutical firm. Here another advantage is the prescription cost can be reduced to a larger extent as with generic prescribing as a patient can demand the drugs belongs to low price version.

The negative side of generic prescribing is as generic prescribing will leave all the things on pharmacist regarding choice of medicines, in this case Pharma companies representative would like to interact with the pharmacist rather than doctors. Here a possibility of nexus between the pharmacist and the drug firm. This will lead to unethical dispensing practice. Unethical in the sense pharmacist will dominate over the patient regarding the choice of medicine as Indian patients rarely have ideas about the medicines.

Another negative effect is with generic prescribing doctors are leaving the decision of dispensing medicine on pharmacist; Pharma firms are diverting their reps towards pharmacist more than docs. Ultimately this will reduce interaction between the med reps and docs which will create a negative effect on doctor’s knowledge on current invention in health care. Now MCI has to rethink on this issue of prescribing the drugs in their generic name. No doubt about that generics prescribing not only reduces the cost of prescription but also stop the unethical marketing practice between the doctors and Pharma firms but as far as health care system is concerned doctors should be on the driver seat and a patient should seat next to him and then comes the pharmacist. This type of system will generate maximum interaction b/w doctor and patient which will be effective for patient in every respect. But generic prescribing will put chemist on the driver seat which may not be efficient as compared to the doctor- chemist interaction.

CONCLUSION: The present government has hinted at ushering in a new law that will coerce doctors to prescribe only generic medicine in lieu of branded one. This will help to break the nexus between pharmaceutical companies and doctors. Patients will be able to buy low-cost drug instead of costly branded drugs Both generic and branded drugs are tantamount to each other when it comes to their efficacy. The law initially appears flawless but there are some loopholes in it. First, I’m quite apprehensive about its implementation. Second, it doesn’t solve the problem but it shifts the nexus from drug producer – doctor to drug producer – distributor. Now, the companies will start approaching distributors by alluring them with high incentives. Due to the paucity of knowledge/awareness, most of the patients will remain unfamiliar with other available drugs. Once the doctor prescribes the drug, ball comes in distributer’s court. He’ll give such a drug that yields high profit and finally, a customer becomes the victim of high-cost medicine. To overcome this, the government should come up with price control policy to mitigate exorbitant prices. The government should also contemplate opening new Pradhan Mantri Jan Aushadhi Kendra through which patient can obtain the medicine at a reduced price.

REFERENCE ID: PHARMATUTOR-ART-2519

REFERENCE:
1.    http://www.patient.co.uk/doctor/generic-prescribing
2.    http://www.joppp.org/content/pdf/2052-3211-6-3.pdf
3.    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2219782/
4.    http://www.nofreelunch.org/patients.htm
5.    http://www.gphaonline.org/about/generic-medicines
6.    http://www.aafp.org/fpm/2002/0300/p45.html
7. http://www.gabionline.net/Reports/Patients-persuade-doctors-to-prescribe-brand-name-rather-than-generic-drugs
8. http://www.npr.org/blogs/health/2013/01/07/168810473/why-didnt-your-doctor-prescribe-a-generic-look-in-the-mirror
9.   http://gabi-journal.net/a-review-of-patient-perspectives-on-generics-substitution-what-are-the-challenges-for-optimal-drug-use.html
10.http://articles.timesofindia.indiatimes.com/2013-01-27/india/36576717_1_generic-drugs-generic-medicines-generic-versions
11. http://social.eyeforpharma.com/market-access/doctors-india-unlikely-follow-guidelines-generic-drugs

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