1.Patients have poor or no knowledge of the price variations among branded and generic medicines, and leave the choice of the medicine to the doctor. 2.The government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers.

1. Generic Drugs Versus Branded Drugs :
As People View
Presented By:
Mr.Tushar D. Morankar*
Guided By:
Dr. S.S. Patil Mrs. Nishita Wani
Ashokrao Mane Institute Of Diploma In Pharmacy
(Inst code 0244)

2. Contents...
• Introduction
• Evolution of Generics
• Branded Drug struggle
• Branded-generic Indian market
• Research survey
• Role of Government
• Generic substitution
• Conclusion
2

3. Introduction... 3
•Generic drugs have secured place in the
market due to the “cost factor” and
Branded drugs due to the “trust-factor”
• Each drug has been given a proprietary
(brand name/trade name) name given by
the company and an international non
proprietory name(INN) (generic name)
• A generic medicine is the same as a
brand-name medicine in dosage, safety,
effectiveness, strength, stability, and
quality.
• But most people are confused about the
difference between the two.

4. 4Evolution of Generics...
 FDA requires the bioequivalence studies of the generic
product and the innovator product.
 Generic manufacturers are not required to submit to
the stringent clinical testing for safety and efficacy
These aspects leads to the reduced effort in terms of man,
material and money required by the generic drug
manufacturers
 Generic drug formulation is copy of brand drug
usually prepared using different inactive ingredients
or combination.

5. 5Branded Drugs struggle...
During the first few years a new medicine becomes available, it
is usually marketed as a brand under a name given by the
pharmaceutical company that developed it.
Companies take out patents (exclusive rights) on each new
drug they discover to ensure they regain the money they spent
on its development
Having a patent means only that company can produce the
medicine for a certain length of time.
Hence the brand name manufacturers expect the returns of
their effort causing the rise in the cost of medicine

6. 6Branded-generic Indian market...
Currently, almost all medicines in India are sold under a brand
(trade) name and medicines are called as branded medicines or
branded-generic
Many pharmaceutical companies manufacture two types of
products for the same molecule, i.e. the branded product
which they advertise and push through doctors and branded-
generic which they expect retailers to push in the market.
This category closely resembles formulations referred to as
‘generics’ worldwide.
Patients’ and doctors’ perception for all branded-generics is
the same irrespective of company.

7. 7Research survey...
The generic medicines are bio-equivalents of their innovator
But these are widely believed as inferior in their therapeutic
efficacy and quality to branded products.
A study from a nationwide survey conducted among 5000
individuals from Brazil reported that 30.4% of the respondents
considered generic drugs to be less effective than branded
medicines.[6]
Contrarily, in Finnish patients, it was observed that 81% of the
participants opined that cheaper generics were effective.[7]

8. 8
A research was done to compare and evaluate the price and
quality of “branded” and branded-generic equivalents of some
commonly used medicines manufactured by the same
pharmaceutical company.
Research survey...
The study highlighted the need to modify the drug price policy,
regulate in generic supply chain, conduct and widely publicize
the quality testing of generics for awareness.

9. 9Role of Government...
Most national governments have been encouraging the use of
generic medicines worldwide and many healthcare systems have
policies of substituting expensive branded original medications with
generic medicines.
In most developed countries, generic medicines are promoted by
competition-enhancing policies operating through health-care
systems to balance expenditure and encourage efficient use of
resources.
To make generic medicines available
to the population, the Department of
Pharmaceuticals, Government of
India launched the Jan Aushadhi
Scheme (JAS) (medicine for the
masses) in 2008.

10. 10Generic substitution...
Generic substitution is a pharmacist-initiated act by which
a different brand or unbranded drug product is dispensed
instead of the drug brand that was prescribed by the
medical practitioner or physician.
Very often, generic prescribing is misinterpreted as
prescribing by a drug's generic name or non-proprietary
name.
In the USA substitution is allowed and patients accept
generic substitution if physician approves of the same.
But such things is not widely promoted in India
Generic subsitution is avoided in case of
Drugs with narrow therapeutic window:
Cardiovascular drugs
Biological medicines

11. 11Conclusion...
Patients have poor or no knowledge of the price variations among
branded and generic medicines, and leave the choice of the
medicine to the doctor.
The general notion and doubt regarding the quality of the generic
version of medicines needs to be erased conducting more studies
and publishing them widely.
The government must take up generic promotional schemes,
general awareness programs on quality of generics to build
confidence among prescribers, pharmacists, and consumers.

12. 12References….
[1] WHO guidance on INN
[2]Understanding the generic drugs https://www .fda.org/drug/development
process approval small business assistance /ucm127615.pdf
[3] Hassali MA, Alrasheedy AA, McLachlan A, Nguyen TA, Al-Tamimi SK, Ibrahim
MI, et al. The experiences of implementing generic medicine policy in eight
countries: A review and
recommendations for a successful promotion of generic medicine use. Saudi
Pharm. 2014;22:491–503
[4]http://www.nhs.uk/Conditions/Medicinesinfo/Pages/Brandnamesandgeneric
s.aspx
[5]G.L. Singal, Nanda. A, and Kotwani. A, A comparative evaluation of price and
quality of some branded versus branded–generic medicines of the same
manufacturer in India, Indian J Pharmacol. 2011 Apr; 43(2): 131–136.doi:
10.4103/0253-7613.77344
[6] Nardi EP, Ferraz MB, Pinheiro GR, Kowalski SC, Sato EI. Perceptions of the
population regarding generic drugs in Brazil: A nationwide survey. BMC Public
Health. 2015;15:117.

13. 13
[7] Heikkilä R, Mäntyselkä P, Ahonen R. Do people regard cheaper
medicines effective? Population survey on public opinion of generic
substitution in Finland. Pharmacoepidemiol Drug Saf.2011;20:185–91
[8] https://www.peoplespharmacy.com/2016/02/15/how-reliable-are-
your-generic-drugs-from-india
[9] Wagner AK, Graves AJ, Reiss SK, LeCates R, Zhang F, Degnan DR.
Access to care and medicines, burden of health care expenditures, and
risk protection: Results from the World Health Survey. Health Policy.
2011;100(2-3):151-158. doi:10.1016/j. healthpol.2010.08.004
[10] Mukherjee K, A Cost Analysis of the Jan Aushadhi Scheme in India
Int J Health Policy 2017, 6(5), 253–256
[11] Karan B. Thakkar and Gauri Billa, The concept of: Generic drugs
and patented drugs vs. brand name
drugs and non-proprietary (generic) name drugs Journal Frontiers in
Pharmacology doi: 10.3389/fphar.2013.00113
References….

14. 14