Generic Drugs or Branded Generics, Which One You Prefer to Prescribe?

Health-care expenditure is very high in India due to the high cost of the drugs and most of it is out-of-pocket expenditure for the patients. The drug which is protected by a patent is called a branded drug and the company which has produced it can fix the price of the drug as it feels fit, for a particular number of years, which is usually 10 years, is usually very high. The drug which is a copy of the original drug, which happens after the expiry of the patent, is equal to the original drug in terms of efficacy, safety, and dosage and is termed as a generic drug.[1] In India, most of the drugs that are available as branded drugs are not actually original drugs, but are copies of the original drugs with a brand name and hence can be termed as branded generics. India is the fourth largest manufacturer of generic drugs and accounts for 22% of the world market but is 13th in its consumption.[1,2] Generics with only their chemical names are termed as pure generics and are much cheaper when compared to branded drugs and branded generic drugs. Branded generics share 90% of the 1 lakh crore market in India.[3] The quality of generic drugs is considered below par when compared to their branded counterparts, even though generic drugs are identical or bioequivalent to the original drugs in their dosage, safety, strength, route of administration, quality of performance, and intended use.[3-5] Doctors' perception about prescribing generic drugs is also very important as most of them consider that low-cost drugs cannot be of higher quality.[6] Some of the patients also do have the same perception. There are a number of studies comparing the generic drugs with their branded counterparts with respect to their pharmacokinetics, pharmacodynamics, and bioequivalence. Studies comparing the original and generic drugs against each other in clinical situations are very rare.[2] Since generic drugs are available at an affordable cost through the Jan Aushadhi outlets fom 2012 in India, patients have started asking whether they can substitute their branded medications with generic medications because of their lower cost. It becomes very difficult to answer the patients queries without data. Our own clinical study (unpublished data) on 39 patients of diabetes and hypertension threw some light in this regard. Diabetics and hypertensives, who were on branded generic drugs, were given equivalent generic drugs for 3 months to know whether the effects were comparable. Majority of the diabetics were in the age group of 51–70 years (69.3%). There were 22 males and 17 females with a mean age of 61.4 ± 9.31 years. Majority of the diabetics were suffering from <5 years to 10 years (71.75%) with a mean duration of 10.31 ± 6.31 years. Ten percent had the disease for more than 20 years. There was no significant difference in systolic (131.4 vs. 130.7) and diastolic (81.0 vs. 80.48) blood pressures (P = 0.841 and 0.632). HbA1C on branded medications was 6.73% ±0.52% and on generics 6.43% ±0.63%. P =0.08 was not significant. HbA1C was lower on generics by 0.3%. Fourteen out of 25 patients (56%) showed a reduction in HbA1C% on generic medications from 0.1% to 1.56% with an average reduction of 0.67%. 7 patients (28%) showed an increase in HbA1C from 0.1% to 0.8% with an average increase of 0.36%. Four (16%) patients did not show any changes and were the same on either medication. Seventy-two percent of the patients showed equal or better HbA1C% on generic medications when compared to their equivalent branded generics. It is stated that observational studies comparing brand name drugs and generic drugs are susceptible to bias in favor of branded drugs.[7] Hence, to avoid any such bias, the same patients who were on brand drugs were given generic drugs to know their efficiency. The data showed very clearly that the generic drugs were noninferior to brand drugs. The reason for the data of this study albeit a small one which is unpublished, finds a mention here is because it is a head to head comparison. If one has to show that either there is a difference or no difference in the action of two molecules, there has to be head on comparison studies. It is very scarce to find head on studies between generics and branded generics and it is very difficult to put forth one's own view without a semblance of evidence. Hence, the data of this small study, even though unpublished, have been utilized to put forth our view. It is very well known that generic drugs cost a fraction of branded or branded generics since the manufacturers of generics need not spend on the research and the development of the drug. The cost difference was anywhere from 38.8% for glipizide, which is a drug under price control to 655.38% for glimepiride.[8] The study mentioned here used glipizide, glimepiride, pioglitazone, voglibose, and teneligliptin as antidiabetics and telmisartan, enalapril, nebivolol, amlodipine, and chlorthalidone as AHDs, and the difference in the costs would be similar to the study cited above. Even the intrabrand variations in the prices of drugs under price control were from 100% to 500%.[9] Many studies have proved that generic drugs are similar in their efficacy to their branded counterparts pharmacologically.[1,5,7,10,11] Generic drugs are supposed to undergo the same procedures for quality assurance as with branded drugs. When it is so, why is it that they are not used extensively? This would have helped reduce the health-care expenditure substantially. A study revealed that there were substantial differences in the cost of the drugs that were available in Jan Aushadhi stores when compared to the cheapest branded medicine available in the market. It also showed that prices of all the drugs available in Jan Aushadhi stores were not lower than branded medicines.[12] Another study revealed that the quality assurance of generic drugs was questionable as effective bioequivalence studies were not required for generics at the time of registration of the molecule.[6] Suboptimal quality of the generics which would affect their efficacy, safety, or both was also shown in some studies.[2,13] There are other reasons for doctors to avoid prescribing generic drugs. If a doctor prescribes a generic drug, it will be left to the pharmacist to decide to push a particular branded generic. Lack of community pharmacy where awareness of the price difference would be not good for the patients and poor awareness about generics among doctors is another factor.[3] Negative perceptions about the generic drugs among the doctors regarding their quality and efficacy and the thinking that "cheaper drugs were not effective" was another principal factor.[6,13] Commission on the branded drugs to the retailers being higher was also an important factor.[3] India needs quality generic drugs as it would cut the health-care expenditure by half and reduce the misery of patients as 70% of expenditure is out of pocket.[7] If India could supply quality generics to the USA and other countries, why not to our own people? Quality assurance with adequate supervision by the regulatory authorities to ensure the bioequivalence of the generic drugs to that of branded generic drugs and to improve the awareness and attitude of the prescribers, is the need of the day in India.[13-15] It has been the personal experience of the authors and perhaps many colleagues in the profession that all the generics they prescribe may not be effective, which is also true with branded generics also, as the manufactures of these are the same. Doctors have to be assured about the quality of generics and they should start prescribing more and more generics because of their cost-effectiveness. Financial support and sponsorship Nil. Conflicts of interest The author, MP, is the emeritus editor of the journal and PK is an advisory board member of the journal. Views expressed are personal.