Research Article - (2022) Volume 14, Issue 7
Received: 19-Jul-2022, Manuscript No. IJDDR-22-12865 ; Editor assigned: 22-Jul-2022, Pre QC No. IJDDR-22-12865 ; Reviewed: 13-Aug-2022, QC No. IJDDR-22-12865 ; Revised: 18-Aug-2022, Manuscript No. IJDDR-22-12865 ; Published: 26-Aug-2022, DOI: 10.36648/1791-809X-16.07-965
To compare and evaluate the price and quality of “branded” and branded-generic equivalents of some commonly used medicines manufactured by the different pharmaceutical company in India. Materials and Methods: Two commonly used medicines: TELMISARTAN and ONDANSETRON manufactured in branded and branded-generic versions by the different company were selected. Price-to-patient and price-to-retailers were found for two “pair” of medicines. Both quantitative and qualitative analysis were performed following the methods prescribed in the Indian Pharmacopoeia on two “pair” of medicines. The tests performed were identification test, dissolution studies. Result & Conclusion Price-to-patient (MRP) for two branded medicines were in the range of 58-23% but for their branded-generics version manufactured by the same companies (PTR) was in the range of 160-16%. Retailer mark-ups for two “pair” of medicines for branded versus branded-generic: telmisartan and ondansetron were 38% versus 160%, 44% versus 16% respectively. Both versions of two medicines were within their permissible range for all the quantitative and qualitative parameters as prescribed in Indian Pharmacopoeia.
Branded Medicines; Branded-Generic; Generics; Mark-ups; Medicine price; India; Quality Testing; In-Vitro; Telmisartan; Ondasetron
Branded and Generic Medicines
Generic drugs
According to FDA “a drug product that is comparable to branded product is dosage form strength route of administration, quality and performance, characteristics, and intended use. It is a copy of branded drug whose patent has expired which has no longer exclusive rights to produce and distribute medicines [1].
Branded drugs
It is the original product that has been developed by pharmaceutical company. It has sole right to manufacture and distribution for a period of time (patent). A brand name drug is a small medicine that’s discovered developed and marketed, by pharmaceutical company. One’s a new drug is discovered, the company files for a patent to protect against other companies making copies and selling the drugs [2-5]. At this point the drug has two names - a generic name and a brand name to make it stand out in the market place.
Brand name medicine is originally discovered and developed by a pharmaceutical company. Brand name medicine is approved by FDA by submitting a New Drug Application along with data regarding proof of characteristics of dosage form, manufacturing, chemistry, stability, efficacy, safety, labelling and packaging. After approval by FDA only, the innovatory company can exclusively market this brand name medicine for a period of patent protection (about 20years or as specified). Brand name medicine is generally sold at high cost to cover expense in research and development of drug [6-9].
View of Professionals Doctors
Doctors generally not prescribed the generic because they are not completely satisfied about safe and effectiveness as compared to branded medicines. They have no any commission from manufacturer for prescribing generics like commission on branded. Doctors are also differ in their belief towards and experience with different medications, medical history, preference may also influence doctor’s decision. When the doctor prescribed generic medicines they do not give patient health result as compared to branded medicines [10-15].
Pharmacist
They get minimum profits on sale of generics drugs as compared to branded medicines. There is also an availability issue of generic drug in Indian market. Less demand of generics by consumers due to less quality and result. Patient strictly follow the prescription which mostly contain branded medicines. The pharmacist can dispense any brand of the drugs when the prescriber writes the generic name on a prescription.
When patents or other periods of exclusivity on brand-name drugs are near expiration, manufacturers can apply to the FDA to sell generic versions by separate name called branded generic. If drug is manufacture and sold by its original name is called pure generics [16-19]. For both, submission of Abbreviated New Drug Application with data regarding bioequivalence study as a proof that the generic version deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. All other data require are same as innovator drug product except preclinical and clinical data regarding safety and efficacy of medicine. Generic and branded drugs may be identical in formulations but differ in certain other characteristics such as shape, release mechanisms, packaging, excipients, expiration date/time and minor aspects of labelling and storage conditions. Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act allowed for the approval of generic copies of many approved drug after the patent had expired.
In India, 90% of branded generics share in the ~1-lakh-crore market.4 India is the largest provider of generic drugs by exporting in more than 200 countries with the 20 per cent of global exports of generics in terms of volume. With flourish of generic market, now battle for better drugs is going on in India [20-22].
Materials
Telmisartan and Ondansetron were purchased from the Lincorn Pharmaceuticals was received as a gift sample. All other chemicals were of analytical grade were issued from Shankersinh Vaghela Bapu Institute of Pharmacy.
Methods
Selection of Drug
The drug Telmisartan and ondasetron were randomly picked for market research.
Market Cost Evaluation
Comparative evaluation of cost between branded and branded. Price-to-patient (MRP) for two branded medicines their brandedgenerics version manufactured by the same companies (PTR) was in the range. Retailer mark-ups for two “pair” of medicines for branded versus branded-generic: telmisartan and ondansetron.
Melting point determination [23-25]
The capillary method used as the standard technique for melting point determination. This method used by placing the drug into a capillary tube and bind them with the end of a thermometer for measuring degree of the melting point. Then fix them with a stand in such a way that the end tip of thermometer and capillary tube should be dipped into 100 ml liquid paraffin oil and heat it until drug start to melt.
Uniformity of weight
10 tablets of each branded and generic were weighed individually using a digital electronic balance and the average weight was calculated from the total weight.
Friability test
Friability test is performed to check the % of weight loss during transportation.
Friability of the tablets was determined using Roche friabilator at 25rpm/min for 4min.
10 tablets were weighed and loss in weight(%) was calculated by the following equation,
Friability=( w1-w2)/w1*100%
Where,W1= weight of 10 tablets
W2= weight after friability
Wetting time / Swelling index
The wetting time of the tablets was measured using a simple procedure (Figure 1). Two circular tissue paper were placed in petridish. Six milliliters of water containing Eosin Y ,a water soluble dye, was added to the petri-dish. A tablet was carefully placed on the surface of tissue paper. The time required for water to reach the upper surface of the tablets was noted as the wetting time (Table 5).
Figure 1: Wetting Time
Disintegration time
It was performed by using USP DT apparatus. This apparatus contain a basket rack having six-open ended glass tubes held in a vertical position. A number ten-mesh stainless steel wire screen is attached to the bottom. To check for disintegration time, one tablet from each formulation was individually added into the basket of disintegration apparatus and temperature was set at 37°C. Finally the time required for complete disintegration was recorded (Table 6).
Dissolution test
Dissolution testing (Figure 2) measures the extent and rate of solution formation from a dosage form. It is important for its bioavailability and therapeutic effectiveness. In vitro dissolution studies were carried out by using the tablet dissolution tester. After reaching the bath temperature and basket temperature at 37.5 degree celcius, a tablet was placed in the basket and the paddle made to rotate at 50rpm.Aliquots of 5ml were collected at different temperature and the drug concentration was analysed by UV spectrophotometer (Figure 3).
Figure 2: Comparison of Branded and Generic Medicine of Telisartan
Figure 3: Comparison of Branded and Generic Medicine of Ondansetron
%Purity
%Purity of a substance can be calculated by dividing the mass of the pure chemical by total mass of the sample and then multiplying this number by 100 (Table 7).
Market Cost Evaluation
Price-to-patient (MRP) for two branded medicines was in the range of 58-23% but for their branded-generics version manufactured by the same companies (PTR) was in the range of 160-16% (Table 1). Retailer mark-ups for two “pair” of medicines for branded versus branded-generic: telmisartan and ondansetron were 38% versus 160%, 44% versus 16% respectively.
Melting point determination
Data of Uniformity of weight (Table 2)
Tablets were passed the weight variation test, according to official guidelines since the percentage deviation was under±7.5%. The uniformity of the weight implies proper tooling of the tablet punching machine (Table 3).
Data of friability test
Tablets of each batch were evaluated for percentage friability and the data’s were shown below (Table 4).
The average friability of all the formulations lies in the range of 0.19% - 0.29% which was less than 1% as per official requirement of IP indicating a good mechanical resistance of tablets.
Data of friability test
Tablets of each batch were evaluated for percentage friability and the data’s were shown below (Table 4).
The average friability of all the formulations lies in the range of 0.19% - 0.29% which was less than 1% as per official requirement of IP indicating a good mechanical resistance of tablets.
Wetting time
For Oldasetron as it is mouth dissolving.
The idea and evaluate the price and quality of “branded” and brandedgeneric equivalents of some commonly used medicines manufactured by the different pharmaceutical company in India is to provide an acceptable and practical approach for the objectives of finding.
After performing a comparative evaluation of cost and in vitro study between branded and branded. Price-to-patient (MRP) for two branded medicines were in the range of 58-23% but for their branded-generics version manufactured by the same companies (PTR) was in the range of 160-16%. Retailer mark-ups for two “pair” of medicines for branded versus branded-generic: telmisartan and ondansetron were 38% versus 160%, 44% versus 16% respectively. Both versions of two medicines were within their permissible range for all the quantitative and qualitative parameters as prescribed in IndianPharmacopoeia.
Pre-compression parameters.
Friability of tablets was less than 1%.
Weight variation test result showed that the weight of tablets tested was within the range ±7.5%.
Disintegration time of the tablets of optimized formulation BRANDED AND GENERIC was
Wetting time for ondasetron of optimized formulation is done 11 (b)-18 (g) sec.
Drug content uniformity study results showed that the drug Febuxostat was uniformly distributed throughout the formulation.
Finally, we conclude that, among prepared formulations, the prepared BRANDED AND GENERIC SHOW immense difference in market price and in testing of both.
The authors would like to thank Shankersinh Vaghela Bapu Institute of Pharmacy to help me to carry out this research.
The authors have no conflicts of interest regarding this investigation.
Branded Medicines; Branded-Generic; Generics; Mark-ups; Medicine price; India; Quality Testing; In-Vitro; Telmisartan; Ondasetron
Branded and Generic Medicines
Generic drugs
According to FDA “a drug product that is comparable to branded product is dosage form strength route of administration, quality and performance, characteristics, and intended use. It is a copy of branded drug whose patent has expired which has no longer exclusive rights to produce and distribute medicines [1].
Branded drugs
It is the original product that has been developed by pharmaceutical company. It has sole right to manufacture and distribution for a period of time (patent). A brand name drug is a small medicine that’s discovered developed and marketed, by pharmaceutical company. One’s a new drug is discovered, the company files for a patent to protect against other companies making copies and selling the drugs [2-5]. At this point the drug has two names - a generic name and a brand name to make it stand out in the market place.
Brand name medicine is originally discovered and developed by a pharmaceutical company. Brand name medicine is approved by FDA by submitting a New Drug Application along with data regarding proof of characteristics of dosage form, manufacturing, chemistry, stability, efficacy, safety, labelling and packaging. After approval by FDA only, the innovatory company can exclusively market this brand name medicine for a period of patent protection (about 20years or as specified). Brand name medicine is generally sold at high cost to cover expense in research and development of drug [6-9].
View of Professionals Doctors
Doctors generally not prescribed the generic because they are not completely satisfied about safe and effectiveness as compared to branded medicines. They have no any commission from manufacturer for prescribing generics like commission on branded. Doctors are also differ in their belief towards and experience with different medications, medical history, preference may also influence doctor’s decision. When the doctor prescribed generic medicines they do not give patient health result as compared to branded medicines [10-15].
Pharmacist
They get minimum profits on sale of generics drugs as compared to branded medicines. There is also an availability issue of generic drug in Indian market. Less demand of generics by consumers due to less quality and result. Patient strictly follow the prescription which mostly contain branded medicines. The pharmacist can dispense any brand of the drugs when the prescriber writes the generic name on a prescription.
When patents or other periods of exclusivity on brand-name drugs are near expiration, manufacturers can apply to the FDA to sell generic versions by separate name called branded generic. If drug is manufacture and sold by its original name is called pure generics [16-19]. For both, submission of Abbreviated New Drug Application with data regarding bioequivalence study as a proof that the generic version deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. All other data require are same as innovator drug product except preclinical and clinical data regarding safety and efficacy of medicine. Generic and branded drugs may be identical in formulations but differ in certain other characteristics such as shape, release mechanisms, packaging, excipients, expiration date/time and minor aspects of labelling and storage conditions. Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act allowed for the approval of generic copies of many approved drug after the patent had expired.
In India, 90% of branded generics share in the ~1-lakh-crore market.4 India is the largest provider of generic drugs by exporting in more than 200 countries with the 20 per cent of global exports of generics in terms of volume. With flourish of generic market, now battle for better drugs is going on in India [20-22].
Materials
Telmisartan and Ondansetron were purchased from the Lincorn Pharmaceuticals was received as a gift sample. All other chemicals were of analytical grade were issued from Shankersinh Vaghela Bapu Institute of Pharmacy.
Methods
Selection of Drug
The drug Telmisartan and ondasetron were randomly picked for market research.
Market Cost Evaluation
Comparative evaluation of cost between branded and branded. Price-to-patient (MRP) for two branded medicines their brandedgenerics version manufactured by the same companies (PTR) was in the range. Retailer mark-ups for two “pair” of medicines for branded versus branded-generic: telmisartan and ondansetron.
Melting point determination [23-25]
The capillary method used as the standard technique for melting point determination. This method used by placing the drug into a capillary tube and bind them with the end of a thermometer for measuring degree of the melting point. Then fix them with a stand in such a way that the end tip of thermometer and capillary tube should be dipped into 100 ml liquid paraffin oil and heat it until drug start to melt.
Uniformity of weight
10 tablets of each branded and generic were weighed individually using a digital electronic balance and the average weight was calculated from the total weight.
Friability test
Friability test is performed to check the % of weight loss during transportation.
Friability of the tablets was determined using Roche friabilator at 25rpm/min for 4min.
10 tablets were weighed and loss in weight(%) was calculated by the following equation,
Friability=( w1-w2)/w1*100%
Where,W1= weight of 10 tablets
W2= weight after friability
Wetting time / Swelling index
The wetting time of the tablets was measured using a simple procedure (Figure 1). Two circular tissue paper were placed in petridish. Six milliliters of water containing Eosin Y ,a water soluble dye, was added to the petri-dish. A tablet was carefully placed on the surface of tissue paper. The time required for water to reach the upper surface of the tablets was noted as the wetting time (Table 5).
Figure 1: Wetting Time
Disintegration time
It was performed by using USP DT apparatus. This apparatus contain a basket rack having six-open ended glass tubes held in a vertical position. A number ten-mesh stainless steel wire screen is attached to the bottom. To check for disintegration time, one tablet from each formulation was individually added into the basket of disintegration apparatus and temperature was set at 37°C. Finally the time required for complete disintegration was recorded (Table 6).
Dissolution test
Dissolution testing (Figure 2) measures the extent and rate of solution formation from a dosage form. It is important for its bioavailability and therapeutic effectiveness. In vitro dissolution studies were carried out by using the tablet dissolution tester. After reaching the bath temperature and basket temperature at 37.5 degree celcius, a tablet was placed in the basket and the paddle made to rotate at 50rpm.Aliquots of 5ml were collected at different temperature and the drug concentration was analysed by UV spectrophotometer (Figure 3).
Figure 2: Comparison of Branded and Generic Medicine of Telisartan
Figure 3: Comparison of Branded and Generic Medicine of Ondansetron
%Purity
%Purity of a substance can be calculated by dividing the mass of the pure chemical by total mass of the sample and then multiplying this number by 100 (Table 7).
Market Cost Evaluation
Price-to-patient (MRP) for two branded medicines was in the range of 58-23% but for their branded-generics version manufactured by the same companies (PTR) was in the range of 160-16% (Table 1). Retailer mark-ups for two “pair” of medicines for branded versus branded-generic: telmisartan and ondansetron were 38% versus 160%, 44% versus 16% respectively.
Melting point determination
Data of Uniformity of weight (Table 2)
Tablets were passed the weight variation test, according to official guidelines since the percentage deviation was under±7.5%. The uniformity of the weight implies proper tooling of the tablet punching machine (Table 3).
Data of friability test
Tablets of each batch were evaluated for percentage friability and the data’s were shown below (Table 4).
The average friability of all the formulations lies in the range of 0.19% - 0.29% which was less than 1% as per official requirement of IP indicating a good mechanical resistance of tablets.
Data of friability test
Tablets of each batch were evaluated for percentage friability and the data’s were shown below (Table 4).
The average friability of all the formulations lies in the range of 0.19% - 0.29% which was less than 1% as per official requirement of IP indicating a good mechanical resistance of tablets.
Wetting time
For Oldasetron as it is mouth dissolving.
The idea and evaluate the price and quality of “branded” and brandedgeneric equivalents of some commonly used medicines manufactured by the different pharmaceutical company in India is to provide an acceptable and practical approach for the objectives of finding.
After performing a comparative evaluation of cost and in vitro study between branded and branded. Price-to-patient (MRP) for two branded medicines were in the range of 58-23% but for their branded-generics version manufactured by the same companies (PTR) was in the range of 160-16%. Retailer mark-ups for two “pair” of medicines for branded versus branded-generic: telmisartan and ondansetron were 38% versus 160%, 44% versus 16% respectively. Both versions of two medicines were within their permissible range for all the quantitative and qualitative parameters as prescribed in IndianPharmacopoeia.
Pre-compression parameters.
Friability of tablets was less than 1%.
Weight variation test result showed that the weight of tablets tested was within the range ±7.5%.
Disintegration time of the tablets of optimized formulation BRANDED AND GENERIC was
Wetting time for ondasetron of optimized formulation is done 11 (b)-18 (g) sec.
Drug content uniformity study results showed that the drug Febuxostat was uniformly distributed throughout the formulation.
Finally, we conclude that, among prepared formulations, the prepared BRANDED AND GENERIC SHOW immense difference in market price and in testing of both.
The authors would like to thank Shankersinh Vaghela Bapu Institute of Pharmacy to help me to carry out this research.
The authors have no conflicts of interest regarding this investigation.
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Citation: Pillai A (2021) A Comparative Evaluation of Cost and In-Vitro Study between Branded and Generic Medicine. Int J Drug Dev Res J, Vol.14 No. 7: 965.
