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Generic drugs: boon or a bane

Tandava Krishnan


I first heard about generic drugs 20 years ago when Cipla an Indian company came up with generic versions of antiretroviral drugs (drugs used to manage cases of HIV/AIDS). Management of HIV/AIDS, hitherto expensive and beyond the reach of many patients finally became affordable.  Health organisations like WHO which were grappling with high burden of the disease especially in African and Asian countries finally found an economical way of reducing the disease morbidity. It was a matter of pride for every Indian, especially those in the medical fraternity.  Despite such a spectacular impact, why are significant sections of doctors wary about prescribing generic drugs?

What does it take to make a drug?
A company intending to make a new drug needs to invest in a good research and development (R&D) unit. This includes good manpower (researchers, technicians etc), expensive equipment and facilities like animal laboratories. Even after investing liberally in all the above mentioned areas, there is no guarantee that some new molecule will be discovered. Taking the argument further, even if a new molecule were to be discovered, there is a less than 10% chance that it would actually reach a stage where it could end up being both safe and effective and therefore suitable to be used as a medicine. The drug may have to be withdrawn because of limited efficacy. Likewise, it might not see the light of the day because of unwanted side effects or harmful adverse effects. The drug needs to pass through a set of expensive clinical trials. So when a drug is indeed found to be suitable to be marketed and sold in a medical store, it not only needs to recover the price incurred to manufacture it but also the amount of money spent in financing all the other possible chemicals which never made it to the market. And the company would also add in a certain amount to make profits out of it.
While considering the pricing aspect, two counter arguments can be made. On one hand, it may be claimed by keeping the prices high, the drugs end up being out of reach of the needy. On the other hand, the company would argue that to attract high quality talent and sustain a cutting edge R&D department to develop newer drugs, the company needs to make profits.

Why is a generic drug cheaper?
The general understanding is that generic drugs are cheaper. But why exactly are generic drugs cheaper? Manufacturers of generic drugs which are a replica of the original molecule just need to pick up a successful drug and replicate it. They do not need to go through the uncertain phase of research . They do not need to conduct costly clinical trials. At the most they may need to conduct bio equivalence trials which are much more economical. It is like purchasing the terrestrial rights of a movie 6 months after the movie has become a hit. The cost of the deal would be less but a profit would still be made by packaging the movie well.

But are generic drugs really cheap?
I once purchased some generic drugs from a medical store and paid an amount of rupees 220 for the same. A month later when I had to buy the same set of drugs, I bought them from an NGO based medical shop known for selling generic drugs and needed to pay only 53 rupees. I was pleasantly surprised and on enquiries was informed that there was a huge difference between the cost and maximum retail price of even generic drugs and the final selling price was at the discretion of the dealer. The drug manufacturer might sell it to the distributor for a higher price. Likewise, the distributor or the chemist might sell it at a higher price for the sake of profit. What we can deduce from this is that while generic drugs are definitely cheaper, there Is no guarantee that the benefit of the reduced price is automatically passed on to the customer.  The government’s move to bring some drugs under price control regime and simultaneously open up generic drug stores might rectify this anomaly to a certain extent but a lot more needs to be done.
During my MBBS a surgery professor conducted a midterm appraisal in a unique fashion. After writing the questions on the board, he announced that he would be reading the latest edition of “The Week” magazine with his back facing us. “You are free to make the best of this situation!”he added candidly. What followed was along the expected lines. The students who were best prepared to face the examination were asked to sit at one end of the row and the guy/girl next to him copied from him/her and was expected to share the notes with the immediate neighbour. Everybody seemed to be happy with this arrangement. However the results were a real surprise. The students who sincerely wrote the exams got the best possible marks while those who copied had 5 marks deducted from their final tally. The professor later clarified that errors crept in when people copied from his/her immediate neighbour’s paper and these increased in number as they got passed on to the fellow students making it very easy to identify who had prepared well for the exam and who had copied. This showed that people committed errors even while copying. Generic drugs are merely a replica of the original molecule and a health care professional is genuinely justified in being cautious about their efficacy especially in life threatening diseases. Studies such as this (https://www.ncbi.nlm.nih.gov/pubmed/17322603) have found the efficacy of generic drugs to be inferior to that of the original molecule.

A copy as good as the original?
So, is there a way to find out if the efficacy of generic drugs is equivalent to that of the original molecule?  Generic drugs in the USA and the European Union are mandatorily tested to ensure that they are biologically equivalent to the original molecule. The aim here is to ensure that quality of the drug is not compromised. Even international organisations like World health organisation (WHO) and Medecins Sans Frontieres (MSF) use drugs which are certified as biologically equivalent. However, in India as stated in this article (http://www.thehindu.com/opinion/op-ed/generic-medicines-in-a-digital-age/article18279695.ece) bioequivalence tests are needed only if a generic drug is introduced into the market within 4 years of the original molecule being marketed. So a drug company introducing the generic version of a drug  after 4 years easily circumvents this regulation. The aim here seems to protect the commercial interest of the company introducing the original molecule rather than to ensure that the generic drug is of a suitable quality.  So a doctor can hardly vouch for the efficacy of a generic drug in India as it has not been tested.

Generic switching
A doctor might with experience get some trends about which generic versions yield better results and which might not. This may lead to him/her prescribing particular brand. However, this move can be negated if the dealer switches the prescribed brand with a similar generic drug manufactured by another company. This is called generic switching. Cynics might say that the doctor is prescribing the said drug as he receives favours from the company while the truth might be that the doctor trusts the brand to benefit his/ her patients.
A global survey of physicians’ and pharmacists (https://www.ncbi.nlm.nih.gov/pubmed/25963230) has shown that while they are aware of the role of generic drugs to improve people’s access to medicines, there is a difference in how health care professionals see them in different health care systems. Countries with more mature health care systems have health care professionals acknowledging the role of generic drugs more readily as they are assured of the quality of the drugs in general as well as the bioequivalence of the generic drugs  in particular.
At this point, it seems that generic drugs in India have untested and therefore doubtful efficacy and though cheap their benefit may not always be passed on to the patient. Moreover the drug which is sold to a patient may not always be the one which the doctor had prescribed.
So every time someone complains about the exorbitant costs of medicine and how they could have been reduced if generic drugs were used as in this case (http://www.thehindu.com/news/cities/Delhi/dengue-death-fortis-found-guilty-of-grave-negligence/article21285758.ece ) we must stop and think about two issues. Firstly, in a life threatening disease, would a doctor use a drug of proven efficacy or a drug of untested efficacy? Secondly, would usage of generic drugs really reduce the cost of treatment significantly? There are no clear cut answers for such questions. Rather than give a clarion call for unbridled usage of generic drugs, our society must demand better regulation of generic drugs in order to ensure quality medical care which is in a true sense economical.

Tnadava KrishnanDr. Tandava Krishnan has done his basic medical education at Kasturba medical college, Mangalore from 1998-2004 followed by post graduate training in ophthalmology at Sarojini Devi Eye Hospital and Regional institute of ophthalmology (Osmania medical college,Hyderabad) from 2005-2008. He did his Research cum Clinical fellowship in Vitreo-retinal services at Sankara Nethralaya from 2008-2011. He also cleared his ICO advanced course exam in the year 2014. Some of the awards received by him include “Best post graduate competitive paper award at the Andhra Pradesh Ophthalmological society meet at Tirupati 2007”, “Archives of Ophthalmology Online Quiz award for November 2008”, “Swarnalata Punshi Award for the best research fellow for the year 2008-2009 awarded by Vision research foundation (Sankara Nethralaya) and Dr K vengal Rao best paper award at the Andhra Pradesh Ophthalmological society meet at Warangal in the year 2013. He has 19 published papers in PUBMED indexed journals. He also has many articles in non PUBMED indexed journals and has co-authored a book titled “The Sankara Nethralaya Atlas of Ophthalmic Ultrasound and Ultrasound Biomicroscopy” second edition and has written a chapter in the book titled "Principles and Practice of Vitreo-retinal surgery". He is currently working at Maxivision Super speciality Eye Hospitals, Madhapur, Hyderabad as a senior consultant Vitreo-retinal services. He is a member of editorial team of TOS today, the official magazine of the Telangana ophthalmological society. His areas of interest include Diabetic retinopathy, Retinopathy of prematurity and Posterior segment diagnostics.