survey on opinion of public on generics

1. EVALUATION OF PUBLIC PERCEPTION
TOWARDS SAFETY AND EFFICACY OF
GENERIC DRUGS
Presented by
k.Sravya
B.Pharmacy
RBVRR WOMENS
COLLEGE OF
PHARMACY

2. CONTENTS
1. INTRODUCTION
2. MYTHS AND FACTS OF GENERIC DRUG
3. LITERATURE REVIEW
4. SURVEY CONDUCTED
5. METHODOLOGY
6. RESULT AND DISCUSSION
7. CONCLUSION

3. • GENERIC DRUG –
• A generic drug is a medication created to be the same as an existing approved brand-
name drug in dosage form, safety, strength, route of administration, quality, and
performance characteristics.
• A generic drug can only be marketed after the brand name drug's patent has expired, which
may take up to 20 years after the patent holder’s drug is first filed with the U.S. Food and
Drug Administration (FDA).
• Branded drugs - A branded drug is a medication that is originally designed and
developed by pharmaceutical company.
• Branded generics- A branded generic is a generic drug that has gone through
the ANDA process, and is assigned a name other than the chemical name. These branded
generic drugs may be developed by a generic drug company, or by the original
manufacturer after patent expiration. The branded generic name is owned by the company.

4. BRAND NAME DRUG GENERIC DRUG
1.Protected by patent 1.Lowest cost version of
branded drugs
2.Supplied by single companies
.
2.Produced by generic
companies.
3.Sold under manufacturer
name
3.Not sold under
manufacturer name
4.price-examples
Linemett-500mg -23.00 Rs Per
10 tablets
Tetracycline -8.94 Rs Per 10
tabs

5. Advantages -
• Accessible to poor.
• Bioequivalent to expensive drugs in market.
• Easy to manufacture.
• Cost effective for healthcare system.
Disadvantage -
• Misconceptions and doubts
• Cost Raises Suspicion Among Many Patients.
• Generic appear different from branded drugs.

6. CURRENT SCENARIO OF GENERIC DRUGS IN
INDIA
• As India is one of the highest per capita out-of-pocket expenditures’ Country, such
generics will save a lot of money which can be used for other health issues.
• In 2008, the Government of India, through the Department of Pharmaceuticals,
started a new initiative “Jan Aushadhi” (a Hindi word literally translated as “Medicine
for People”).
• Until March 15, 2018, 3200 Jan Aushadhi stores were operating in more than 33
states/union territories across India. There are not enough Jan Aushadhi stores,
possibly 3200 against more than 8 lakh retail pharmacies in existence, with many
rural areas still underserved.
• 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.

7. MYTHS AND FACTS OF GENERIC DRUGS
ingredient
•Generic and brand name drugs have same active ingredients
•Not all brand drugs available as generics.
prescription
•Need prescription like brand ones.
•Generics -not cheaper because they are inferior versions of branded drugs
cost
•Ph companies invest on branding, advertising, research, and development- influence the cost
•difference in price has nothing to do with the main active ingredients.

8. Safety and efficacy-
Generic drugs are equivalent to the brand formulation they have the same active
substance (with a difference of ±5%), the same pharmaceutical form, the same
therapeutic indications and a similar bioequivalence (±20%) relatively to the reference
medicinal product.
 At a physiological level, generic medicines behave very similarly to their originator
counterparts; therefore, theoretically, they may show a similar efficacy.
Although use of generic medications has increased rapidly in the past 2 decades, in
recent national surveys about one-third of patients, physicians, and pharmacists were
still classified as sceptics about the safety, effectiveness, and quality of generic
medications.
 Negative perceptions may lead patients to switch back to the brand-name product after
generic substitution.

9. o In 2011 G.L.Singal et al., conducted a
comparative evaluation of price and
quality of some branded versus
branded–generic medicines of the
same manufacturer in India
o n 2013, Luca Gallelli et al., discussed
about the Safety and Efficacy of generic
drugs with respect to brand
formulation
• - Both versions were within their
permissible range for all the
quantitative and qualitative parameters
as prescribed in Indian Pharmacopoeia.
• -the use of generic drugs could be
related with an increased days of
disease (time to relapse) or might lead
to a therapeutic failure; on the other
hand, a higher drug concentration
might expose patients to an increased
risk of dose-dependent side-effects.

10. • In 2014, Alrasheedy A, et al., Performed
a study on patient knowledge,
perceptions, and acceptance of generic
medicines.
• In 2018, Ruta Joshi et al., conducted a
study to determine if consumer
perception of generic drugs is
equivalent to their perception of
branded drugs
• - there is a need for educational
interventions and activities to educate
patients about generic medicines.
Hence health care professionals need
to play a more active role by educating
patients and recommending generic
medicines to their patients.
• -aside the constructional reasons for
the lack of acceptance of generic drugs,
it has come across that the beliefs and
attitude of people towards the use of
generic drugs is a giant barrier.

11. SURVEY CONDUCTED
• AIM - Evaluation of Public perception towards safety and Efficacy of
Generic Medicines and reviewing the quality aspects of generic drugs.
• OBJECTIVES:
• Review the consumer’s knowledge, attitudes and opinions on the use of
Generic Medicines.
• Review the consumers opinion towards the safety and efficacy of Generic
Drugs
• To assess the generic drug usage pattern
• To Bring Awareness among public on Generic Drugs consumption.
• To find out Role of Doctors and Pharmacists in Generic Drug usage
• To compare and contrast the public perception of generic drugs’ quality
aspects with published literature.

12. METHODOLOGY
• Study design-An Investigative and unacknowledged e-survey was conducted
among individuals of 18 years above
• Study timing-The data collection was performed between May 1 2021 to May 16
2021.
• Questionnaire content-The questionnaire was combined form of Open ended and
Multiple-choice questions with Predefined answers offering respondents the
possibility to choose the correct options by rank among several Options to know
the public awareness, their knowledge and their perceptions about generic drugs.
• Data collection and Analysis -The questionnaire was designed and incorporated
into the Google survey tool (Google Forms) and a shareable link was generated
and shared on What's app to various people and groups.
Results obtained from the questionnaire were assessed and discussed
accordingly.

13. • Several aspects related to generic drugs were asked in
questionnaire to understand whether consumers
preferred to use these drugs as compared to the
branded ones and also to know their opinion about the
generic drugs. Total 311 responses were received.
• Responses were collected from Telangana and AP
States.
• RESULT-Age-30-45{55%}
• 18-{25%} >50-{20%}
• Gender of participants-59.5% Females and 40.5% Males
• Among responders 50.2% were students.
• . Responses were collected from rural and urban areas
of Telugu states with 74.28% in Telangana and 25.7 %
percentages in AP respectively

14.  KNOWLEDGE ABOUT GENERIC DRUGS
• Here the Students have more
good knowledge -(41.8%
among 50%),
• Private employees (21.5%
among 27.3%)
• Government employees (6.1%)
• others (12.8% among 16.6%
which include house wife's,
business man, self-employed
1
Do you know that A generic drug is a medication
created to be the same as an already marketed
brand-name drug in dosage form, safety, strength,
route of administration, quality, performance
characteristics, and intended use?
Yes%
82.9
No%
17.1
Good
2
Do you know that A branded medicine is the original
product that has been developed by a pharmaceutical
company?
84.8
15.2 Good
3
Do you know that A branded medicine is the original
product that has been developed by a pharmaceutical
company?
67.7 32.3 Above Average
4
Do you know what is a generic and branded drug?
77.8 22.2 Good
5 Do you know what is a branded drug? 68.8 31.2 Above average
6
Do you know that Generic medicines are available at
cheaper rate?
69.8 69.8 Above average

15. • Accessed on 27 January 2019) The knowledge about the generic drugs India was
increased compared to past. Jan Aushadhi Campaign facilitated by Pharmacists and
Sthyamevajyate like programs in mass and social media might be contributing to
this improvement of awareness.
• Most of them got awareness from Pharmacist as shown in Figure and rest of them
got from other sources I.e., doctors and TV and relatives and friends .
•

16.  FREQUENCY OF GENERIC DRUG USE AND STORE VISITS
28.30%
4.20%
52.10%
15.40%
Sales
NEVER ALWAYS RARELY FREQENTLY
• Only 43.5 % consumers visited generic drugs
and 43.4% never visited a generic store.
• most of the consumers -(52.1%) rarely use
generic medicines.
• Frequently use (15.4%)
• Very few -Always use generic drug(4.2%)
• Almost never used generics (28.3%)

17.  PRACTICE OF GENERIC DRUG PRESCRIPTION
• As per survey responses the practice of generic
drug prescription by doctors was only 33.2% .
• 45.8% people have come across getting a
substitute of the brands prescribed by the
pharmacist from the Pharmacy.
• Although the doctors had good knowledge and the
attitude regarding generics this was not reflected in
prescription rates-- gap b/w knowledge with
attitude and practice.
 FREQUENCY OF DRUG SUBSTITUTION-
substitution took place –
many times for 8%
frequently for 12.8% people
sometimes for 25% people
substitution never took place to 54.2%.
8%
12.80%
25%
54.20%
0%
10%
20%
30%
40%
50%
60%
many times frequently sometimes never
Frequency of subsitution

18. ASPECTS OF CONSUMERS ON GENERIC DRUGS REGARDING
QUALITY SAFETY, AND EFFICACY
• Most of the consumers - 41.2% don’t
use generic drugs because doctors do
not prescribe them.
• 27% are concerned about the quality
and efficacy
• 3.2% of people think that both brands
and generics are similar in price
• only 28.6% of people use them
41.20%
27%
3.20%
28.60%
0.00% 10.00%20.00%30.00%40.00%50.00%
don’t use-doctors don’t prescribe
concerned -safety,efficacy
price of both similar
use generic drugs
ASPECTS

19. PERCEPTIONS OF CONSUMERS ON GENERIC DRUGS
REGARDING QUALITY SAFETY, AND EFFICACY
• With questions about quality the percentage of
participants that said that about the generic
medicines –
• consumers who said quality is different were up
to 11.3%.
• consumers who felt safety is less -up to 12.5%,
• who said both quality and safety is different -
40.5%.
• of consumers stated that both quality and safety
of generics are same as brand -15.8%
- 12.2% stated that quality is same
- 7.7% stated that safety is also same • Though the consumers had a good knowledge on
the generic drugs the results reflected negative
about their perception on generics. This showed
that most of them are concerned about quality
and safety.

20. Most of the people don’t use generics I.e., 52.7%
the below graph is for people who are using the
generics
2%
8.60%
6%
9.60%
20.10%
0% 5% 10% 15% 20% 25%
GI disorders
hypertension
diabetics
cough,cold,fever
vit deficiencies
DISEASES FOR WHICH PEOPLE
USE GENERICS
Series 1
categories of medicines- negative response
of 59 % that they do not use generic
medicines.
41% of consumers gave positive responses
.among this most of category drugs used
are shown in below fig ( %)
CATEGORIES OF MEDICINES
USED BY CONSUMERS

21. • generic medicines they are using, we came to know that most of them are using Multivitamins,
Vit-c, Calcium, Paracetamol, the use of these medicines was increased due to the covid –19
pandemic, since vit-c,vitd3, and multivitamins act as the immunity boosters also since the
generics are cheaply available .
• It was also observed that the consumers are not using the generic medicines for Serious or
moderate diseases.
• It was also observed that only 41.2% consumers predicted that they will intend to use the generic
medicines in future and 11.6% said No and 47.3%people said that they may choose to use the
generic medicines in future.
• QUALITY ASPECTS OF GENERIC DRUGS
• Generic drugs are held to the same standards of quality as those required for brand name
drugs. As part of our generic drug review and approval process, FDA scientific experts assess each
drug product application to verify the active ingredients and drug product have adequate quality
controls and are going to be manufactured to meet quality standards.
• Hence, the critical issues that affect the quality of generic drugs are purity, potency, stability, and
drug release, and these should be controlled within an appropriate limit, range, or distribution to
ensure the desired drug quality.
• Generic drugs are typically 30-80% cheaper than the original versions.

22. PERCEPTIONS OF QUALITY OF GENERIC
MEDICINES
although perceptions about the quality of generic medicines have improved, mistrust
remains, often reflected by assertions such as “(the)more you pay, better the quality".
medicines are a crucial building block of the health system and contribute to health and well-
being of individuals and populations and negative perceptions that are unfounded in empirical
evidence, if unaddressed, can negatively influence utilization of health services, particularly in the
public sector.
Awareness
• more people have a better awareness of branded drugs in both urban and rural areas, even if they are more expensive
Commission receive
• because doctors often receive a ‘commission’ from drug-makers for prescribing particular branded drugs.
• Medical shop owners also receive kickbacks and have been known to push branded drugs for this reason.

23. Suggestions to improve generic drug usage in
India
The government should ensure uniform quality across all the generics, and experts in the
field of medicine say only then will doctors prescribe them willingly and with confidence.
. To ensure that the quality of generic drugs is equivalent to its branded version and that this
equivalence is scrupulously maintained.
the government should also bring legislation to ensure compliance in generic drug
manufacturing and testing.
Confidence and habit of generic prescribing need to be inculcated into our medical field.
On the other hand, ensuring quality with strict regulatory mandate and providing updated
information regarding the generic drugs will eventually enhance prescription of generic
drugs.

24. o Although the consumers had a good
knowledge on generic drugs there is a
huge difference between their knowledge
and attitude, perceptions.
o Most of the consumers were not sure about
the Safety and efficacy of generic drugs.
Most of them are worried about their
quality aspects.
o In spite of having knowledge of generics
they have negative perceptions on
equivalence, effectiveness and quality of
generics.
o The availability of Exclusive generic stores
are still very less in number even after
initiation of Janaoushadhi stores from
Government.
o Physicians practice in prescribing the
generics to the patients was poor.
There is a need of multidimensional
approach in escalating the use of generics
A stringent Quality control vigilance from
Government sector can enhance the trust in
Generics among consumers
access to medicines programmes must
invest systematically in information on
Generic drug quality
and establish ways to increase trust in
government-provided healthcare.
Pharmacists could play a critical role in not
just promoting generic usage but also
enhancing patient knowledge of generics.
Hence, we would conclude that this
research highlights the need of a bigger
effort in the country on generics
information and usage.