INTRODUCTION:

Generic drugs:

The term "generic drug" refers to a medication that shares the same chemical composition as a drug that was first covered by a chemical patent. Following the expiration of the patents on the original medications, generic medications may be sold. The medical profile of generic medications performs similarly to that of their proprietary counterparts since the active chemical ingredient is the same. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, colour, taste, and packaging.¹

Branded drugs:

A drug that is patent-protected and sold by a pharmaceutical business under a particular brand name or trademark. Brand-name medications may be bought over the counter or with a prescription. Any pharmaceutical product that is covered by the Plan's pharmacy benefit and is prescribed, including over-the-counter medications supplied in accordance with a prescription, medicine, agent, substance, device, supply, or other therapeutic product that is not a generic drug, is referred to as a "Brand Drug" or "Brand"²

Brand Drug		Generic Drug
No diffrences	Active ingredient		No diffrences
Higher in cost	Price		Lower in cost
Covered if no Generic Form Exists	Insurance coverage		Normally Alwayes covered
Tested and approved by the FDA	Inactive ingredients		May differ –But proven to be acceptable by the FDA
No diffrences	Strength / dosage		No diffrences
Drugs are standered in Size, Color, Packaging etc.	Appearance/ Look		Packaging and the Drug itself may look different

Figure 1: Difference between generic and branded drugs

Antibiotics:

The antibiotics into clinical use was arguably the greatest medical breakthrough of the 20th century³ In addition to treating infectious diseases, antibiotics made many modern medical procedures possible, including cancer treatment, organ transplants and open-heart surgery. However, misuse of these valuable compounds has resulted in the rapid rise of antimicrobial resistance (AMR) with some infections now effectively untreatable.⁴ Patients in India pay for about 80% of all medical expenses. The National Pharmaceutical Pricing Authority (NPPA) was founded in 1997 to guarantee that medications would be accessible and reasonably priced. One such initiative under the NPPA is the Drug Price Control Order (DPCO) of 2013. The government launched DPCO with the intention of lowering the price of necessary medications.⁵Every year,the NPPA releases a pricing list of critical medications to help pharmaceutical firms manage drug prices in India. It establishes the maximum price for a planned formulation of any brand-name or generic medication produced by a pharmaceutical company with a market share more than or equal to 1%.

Any new medication released by a pharmaceutical business, whether it be branded or generic, should cost less than or equal to the maximum amount set by the government for that Ceiling price is calculated as:

Ceiling price = average price to retailer × (1 + percentage of margin to retailer)

The manufacturer must change the price of a medicine within 45 days after being contacted by the government if it is being sold at a higher fixed price. In addition to paying a fine, the manufacturer must also deposit the overcharged sum, together with interest, to the government⁵

Figure 2: Classification of Antibiotics

Side effects of Antibiotics:

Antibiotics can have side effects whenever they are used. From mild to extremely serious health issues, common side effects can include:

· Rash

· Nausea

· Diarrhea

· Yeast infections

Why is it important to take antibiotics only when they’re needed?

Antibiotics are essential for treating infections and have prevented many fatalities. However, using antibiotics at any time increases the risk of side effects and the development of antibiotic resistance, one of the biggest threats to public health.

The advantages of using antibiotics typically outweigh the dangers of side effects and antibiotic resistance. But an excessive number of antibiotic prescriptions are overprescribed and abused, endangering the effectiveness of these vital medications.⁶

Price variability among the antibiotics:

A comparison and variance analysis was conducted on the prices of 34 oral antibiotic medications that were offered by the hospital pharmacy of a tertiary care hospital. Of these 34 medications, there were 117 brands available that doctors had prescribed. [Figure 3] shows the number of brands that are offered in different categories according to the percentage price variation. When compared to other price variation categories, the group of thirty brands that were available fell into the 0–25% price variation category⁷

Figure 3: Top 5 Antibiotics Active Pharmaceutical Ingredients

Azithromycin (25%) ciprofloxacin (21%), amoxicillin (33%), cefixime (39%), and amoxicillin potassium clavulanate (52% of IP clinics) were the five most often used active components (across all formulations). The top five, however, differed according on the formulation: amikacin was most frequently used for injections, amoxicillin potassium clavulanate was most frequently used for syrups, suspensions, and drops, and amoxicillin was most commonly used for tablets.

The anatomical therapeutic chemical (ATC) categorization system, which groups medications according to their pharmacological and therapeutic qualities, is used to categorize all of the available antibiotics. The ATC class that was most frequently supplied was "other beta-lactam antibacterials," which included cephalosporins such cefalexin, cefuroxime, and cefixime, and "beta-lactam antibacterials, penicillin’s," which included amoxicillin, ampicillin, and their combinations (78% of IPs). Three-quarters of the IPs were supplied with quinolones, 29% with macrolides, lincosamides, and stretogramins, 8% with tetracyclines, and 7% with aminoglycoside antibacterials. Antibiotic combinations were supplied in 21% of the IPs overall⁷

When all brands were taken into consideration, the median percentage mark-ups ((sales price—purchase price)/sales price)) × 100) for the IPs for the top five antibiotics varied from 15 to 22% for tablets and from 10 to 20% for syrups. For a given antibiotic, there was significant variation in markups between the most and least expensive brands, particularly for tablets: the lowest priced brands had markups ranging from 12% to 57%, while the highest priced brands had markups ranging from 8% to 44%. The most stocked brands, however, had markups that were more consistent, ranging from 15% to 24%. Overall, the markups for the various brands of syrup, suspension, and drops were more consistent than those for tablets, with the exception of azithromycin, the most expensive brand, which had an outlier with a 100% markup.

When the number of drug brands was examined, it was discovered that while the range of prices increased along with the number of brands, the mean price variation stayed the same⁸ [Table 1].

Table 1: Percentage Price variation with number of brands available for drug

Number of brands available for a drug	Percentage price variability (%)
Number of brands available for a drug	Mean	Standard deviation	Range
<3	100.71	28.53	34.93-165.07
3-5	103.63	23.9	36.69-177.94
>5	99.49	82.93	23.35-530.17

The situation has led to greater price variation among drugs marketed. Antibiotics class of drugs is very commonly prescribed for prophylaxis and also for the treatment of infectious disease. The prices of the oral antibiotics prescribed and available in hospital pharmacy were compared. More than 50% price variation was noted in 35% of the brands. Only 30 brands were in the group of 0-25% price variation. Remaining 53 brands had price variation above 25% and, in some cases, more than 100% price variation which is not an acceptable situation to patients. The average price variation for this study was 93%. In a study conducted by P.R. Shankar et al. in Nepal, they found out that mean percentage price variation for antibiotics was around 38.1%.⁹

In a study conducted by Rataboli P.V et al where a database of drugs marketed in India was used to find the percentage price variation from average of marketed antibiotics, 3 drugs fell in 0 - 25% and 25.1 - 50% variation group, 5 drugs fell each in 50.1 - 75% and 75.1 - 100% while 11 drugs were having more than 100% price variability.¹⁰

Why branded drugs costs more than generic drugs:

Branded drugs are substances that have been developed and distributed by the pharmaceutical industry following a series of clinical trials conducted under different regulatory bodies to demonstrate the product's safety and effectiveness. The following factors are to blame for the sharp increase in branded drug prices:

· Clinical trial costs

· Production costs

· Invention costs

· Pharmaceutical patenting

· Manufacturing, and advertising¹¹

Figure 5: Dosage forms of Antibiotics¹²

Figure 6: Distribution of branded and generic medicines difference in their mean cost.¹³

Figure 7: Stability of antibiotic resistance in bacteria. Antibiotic resistant bacteria (AbR) may be as fit (i) or less fit (ii) than their sensitive variants. Fitness may be restored (iii) by true reversion of the resistance conferring mutation or (iv) by acquisition of compensatory mutations that restore fitness to different extent without causing loss of resistance (AbR*).¹⁴

Comparative cost analysis of generic and branded antibiotics in India:¹⁵

Sr. No.	Name of drug formulation	Dosage	No. of brands	Unit price (INR)
Sr. No.	Name of drug formulation	Dosage	No. of brands	Median brand price	Max brand price	Min brand price	Generic price as per JAS
1.	Inj. Ceftriaxone	2 gm	15	135	171	100.7	NA
2.	Tab. Cefixime	200mg	643	6	49	0.78	4.15
3.	Tab. Azithromycin	1 gm	15	36	70	30	NA
4.	Tab. Azithromycin	500mg	609	22	80	1.98	8.06
5.	Tab. Cotrimoxazole	960 mg	61	1.39	2	1	NA
6.	Capsule Doxycycline	100mg	79	2.9	7.8	0.6	1.16
7.	Tab. Ciprofloxacin	500 mg	546	5.94	13.75	0.6	1.7
8.	Inj. Piperacillin-Tazobactam	4.5gm	229	450	984	14.87	164.21
9.	Inj. Imipenem	500 mg	9	1310	1700	538	385
10.	Inj. Meropenem	1 gm	20	1499.5	2889	592	214.6
11.	Tab. Metronidazole	400 mg	28	0.63	1.9	0.45	0.385
12.	Tab. Amoxycillin-Clavulanate	625mg	346	27	54	1.63	8.7
13.	Inj. Amoxicillin-Clavulanate	1.2gm	125	170	250	90	55
14.	Inj. Vancomycin	1 gm	15	700	778	450	NA
15.	Inj. Cefotaxime	1 gm	126	38.57	110	22.3	15.93
16.	Inj. Ampicillin	1gm	10	21.67	25.5	14	7.2
17.	Inj. Clindamycin	600mg	14	149.5	245	120	NA
18.	Tab. Amoxycillin	500mg	264	6.3	10.38	2.4	2.62
19.	Tab. Moxifloxacin	400 mg	17	45	75	5.5	12.6
20.	Tab. Nitrofurantoin	100 mg	8	6.03	10.75	1	1.52
21.	Tab. Cefuroxime	250 mg	349	26	50	2.6	5.6
22.	Inj. Amikacin	500mg	20	62.45	84.7	38.55	25.2
23.	Inj. Gentamycin	80mg	63	7.6	12	4	2.25

Table 2: Cost of drugs available in pharmacy during survey

Branded Name	Generic Name	Pack Quantity/ Tablet	Cost MRP	Retail Cost	Customer Cost
Amoxyclav cv-625	Amoxycillin trihydrate 500mg and potassium calvunate dil.125mg	10 tabs	182/-	80/-	110/-
Moxispin 500mg	Amoxycillin 500mg	10 tabs	72/-	30/-	50/-
Zatura 500mg	Azithromycin 500mg	10 tabs	71/-	35/-	50/-
Zim 200mg	Cefixime 200mg	10 tabs	96/-	60/-	80/-
Sentum 500mg	Cefuroxime acetyl 500mg	10 tabs	491/-	200/-	250/-
Cekoda 100dt	Cefpodoxime proxetil	10 tab	100/-	60/-	82/-
Sentum cv 500mg	Cefuroxime 500mg and potassium calvunate 125mg	6 tabs	530/-	200/-	250/-
Cefoder 325mg	Cefodoxime 200 mg and potassium calvunate 125mg	10 tabs	325/-	180/-	210/-

Visit to the generic and branded drug store

Interview with Pharmacist and consumer:

I started by asking some inquiries about the project "Comparative Study of Generic and Branded Antibiotics" at the drugstore in Swapnil and Harsh. The interview began as soon as they were responsible and engaged in discourse about my subject. The chemist explained to me the price of Antibiotics and said that because the area is rural, a certain quantity of generic medications should be made available to patients based on their financial situation, as branded medications are expensive and cannot be afforded by underprivileged patients. However, branded medications provide more accurate results even though they cost more than generics. Although generics may not provide the same level of effectiveness or length of action, they can provide temporary relief and are still reasonably priced for those in need. When I asked the chemist why he had to sell generics instead of branded products so he could make more money, he said that pharmacists have a responsibility to the community as well as to themselves. He also gave me information on the price, efficacy, and comparison of branded and generic medications.

CONCLUSION:

Generic drugs are more cost-effective and highly reliable drugs. They are easily available and have a high consumption rate due to their minimum cost price. According to consumer opinion, the safety and efficacy of these drugs are similar to that of branded drugs. Numerous studies have demonstrated that by switching from more expensive branded medications to less expensive generic versions, consumers can save between 10% and 90%. According to research, the average cost of generic medications is Rs 148.2, whereas the average cost of branded medications is Rs 1426.8 On average there is a difference of 75-80% in the cost of generic and branded medicine.

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

ACKNOWLEDGEMENT:

Authors are thankful to Management, Principal and Research guide of Kamla Nehru College of Pharmacy Butibori Nagpur for providing necessary facility for review work

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Received on 07.03.2024 Revised on 22.08.2024

Accepted on 29.11.2024 Published on 03.03.2025

Available online from March 07, 2025

Asian J. Res. Pharm. Sci. 2025; 15(1):99-104.

DOI: 10.52711/2231-5659.2025.00015

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