ASSESSMENT OF THE PRICE ,DISTRIBUTION PATTERN AND QUALITY OF

SEVERAL PARALLEL IMPORTED PRODUCTS IN KAPSABET AND ELDORET

CHEMISTS.

BY

VELMA SHARON

BPHARM/2021/87070.

RESEARCH PROJECT SUBMITTED IN PARTIAL FULFILMENT OF

REQUIREMENT FOR THE AWARD IN BACHELOR OF PHARMACY SUBMITTED

TO THE SCHOOL OF PHARMACY OF MOUNT KENYA UNIVERSITY.

SCHOOL OF PHARMACY.

DEPARTMENT OF PHARMACEUTICAL SCIENCES.

MOUNT KENYA UNIVERSITY.

JANUARY 2024.

i
 DECLARATION.
I hereby certify that my project is entirely unique with no submissions for credit toward a degree

from another university.

VELMA SHARON

BPHARM/2021/87070.

Signature………………………………… Date ……………………

Supervisor’s approval

This project has been submitted for university examination with my approval as university

supervisor (s).

DR EPA TWAHIRWA.

Signature………………………………… Date ……………………

Department of Pharmaceutical Chemistry

Mount Kenya University.

ii
 DEDICATION.
I dedicate this research project to my beloved parents, Fred and Jenifer Owuor and my siblings for

their love and continued mental and financial support towards accomplishment of this project.

iii
 ACKNOWLEDGMENT.
First, my heartfelt gratitude goes to God for the gift of life and good health, His guidance

throughout my life at school and even during the start of this study. I also express my gratitude

for giving me wisdom and understanding throughout the course of my 5-year degree in

Pharmacy program and research project.

I would like to sincerely thank my supervisor Dr. Epaphrodite Twahirwa for his input, guidance

and support throughout this study .I particularly acknowledge my laboratory technician Mr.

Clement Wangui for the practical support time ,confidence and dedication throughout the entire

process. His insight was very beneficial in my completion of this project . I am truly humbled.

A special appreciation to my classmates and colleagues, we’ve been there for each other through

this journey .

My appreciation also goes to the school of Pharmacy and the Department of Pharmaceutics for

the support in the laboratory analysis and interpretation of the results.

iv
 ABSTRACT.
The study delved into the pharmaceutical industry's parallel importation practices, particularly in
Kapsabet and Eldoret. Five sample drugs, atorvastatin, lopreamide, diamicron MR,Natrilix SR and
Duphaston were chosen for analysis. Data collection involved a combination of market surveys and
observations, with the researcher disguising themselves as a shopper during visits to the 27
outlets.The observed prices for parallel imported drugs were detailed during the study.Despite the
seemingly comparable prices to their original counterparts, the parallel imported samples raised
concerns. Notably, they did not meet the guidelines set by the Pharmacy and Poisons Board (PPB),
with issues such as drug instructions not being in English or Kiswahili and issues with labelling
requirements and weight variations of the drugs.A significant finding was the unsuitability of the
parallel imported drugs for Kenya's climatic conditions, posing potential health risks to patients with
chronic conditions. The study called for government intervention through the PPB and Ministry of
Health to address ambiguities in parallel importation, eliminate unauthorized importers flooding the
market with fake brands, and ensure fair competition among importers.Futhermore,laboratory assay
of atorvastatin calcium was carried out using HPLC method to determine the drug content ,that will
greatly affect its quality and overall safety.The concentration of the sample of parallel imports at
various peak areas of the chromatogram was also determined during the laboratory analysis.The
recommendation extended to regulating drug prices and scrutinizing officials at ports and Kenya
Revenue Authority (KRA) to ensure the importation of quality drugs into the country. Overall, the
study emphasized the importance of government involvement to safeguard public health and
maintain a fair pharmaceutical market.

v
 TABLE OF CONTENTS

DECLARATION............................................................................................................................ii

DEDICATION............................................................................................................................... iii

ACKNOWLEDGMENT................................................................................................................iv

ABSTRACT.................................................................................................................................... v

LIST FIGURES..............................................................................................................................ix

LIST OF TABLES.......................................................................................................................... x

ABBREVIATIONS AND ACRONYMS......................................................................................xi

CHAPTER ONE :INTRODUCTION............................................................................................. 1

1.1Background information.............................................................................................................1

1.2Problem statement and Justification of the study....................................................................... 3

1.3 Research objectives................................................................................................................... 4

1.3.1 General objectives.................................................................................................................. 4

1.3.2 Specific objectives..................................................................................................................4

1.4 Research questions.................................................................................................................... 4

1.5 Significance of the study........................................................................................................... 5

1.6 Scope of the study......................................................................................................................5

CHAPTER TWO:LITERATURE REVIEW...................................................................................6

2.1 The concept of parallel importation...........................................................................................6

vi
2.2 Parallel importation of medicine in Kenya. .............................................................................. 7
2.3Effects of parallel importation of medicines and pharmaceutical products in Kenya. .............. 8

2.4 Intellectual Property Act. .......................................................................................................... 9

2.5Safety , Quality and stability of drugs parallel imported. ........................................................ 10

.......................................................................................................................................................

12

CHAPTER THREE :RESEARCH DESIGN AND METHODOLOGY. .................................... 13

3.1 Introduction. ............................................................................................................................ 13

3.2Study design ............................................................................................................................. 13

3.3 Study area................................................................................................................................ 14

3.4 Inclusion and exclusion criteria .............................................................................................. 15

3.4.1 Inclusion Criteria ................................................................................................................. 15

3.4.2 Exclusion Criteria ................................................................................................................ 16

3.5 Data collection ........................................................................................................................ 16

3.5.1 Research Instruments. .......................................................................................................... 16

3.5.2 Sampling Procedure ............................................................................................................. 16

3.6Ethical considerations .............................................................................................................. 16

3.7 Laboratory analysis of atorvastatin. ........................................................................................ 16

3.7.1 HPLC Method development. ............................................................................................... 16

3.7.2Reagents and chemicals. ....................................................................................................... 17

3.7.3Procedure .............................................................................................................................. 18

vii
3.7.4 Weight variation................................................................................................................... 18

CHAPTER FOUR:RESULTS AND DISCUSSION.....................................................................19

4.1 The determination of the proportion of chemists selling parallel imported non-complaint drugs.

19

4.2 Pricing of the parallel imported and original drugs in Eldoret................................................20

4.3Results of assay of atorvastatin using HPLC............................................................................22

4.3.1 Weight variation for atorvastatin..........................................................................................22

4.4.2Assay of atorvastatin............................................................................................................. 24

4.4 Discussion................................................................................................................................26

4.5 Analysis of atorvastatin using HPLC method......................................................................... 32

CHAPTER FIVE:CONCLUSIONS AND RECOMMENDATION.............................................35

5.1 Conclusion...............................................................................................................................35

5.2 Recommendation.....................................................................................................................36

REFERENCES..............................................................................................................................41

viii
LIST FIGURES

Figure 1: Price differentials of the selected drugs in Eldoret........................................................ 21

Figure 2: ICH Climatic zones........................................................................................................27

Figure 3. Figure Showing parallel import of Duphaston...............................................................28

Figure 4 Showing imodium parallel import.................................................................................. 29

Figure 5 Showing Diamicron MR parallel import.........................................................................30

Figure 6 Showing Natrilix SR parallel import...............................................................................31

Figure 7: Graph of assay of atorvastatin using HPLC...................................................................32

Figure 8 Chromatogram of the diluent.......................................................................................... 38

Figure 9 .Chromstogram of the sample......................................................................................... 39

Figure 10 Chromatogram of the standard......................................................................................40

ix
LIST OF TABLES

Table 1: Pricing of the parallel imported and original drugs in Eldoret........................................20

Table 2: Weight variation for atorvastatin.....................................................................................22

Table 3: Assay of atorvastatin....................................................................................................... 24

Table 4: ICH Climatic zones......................................................................................................... 26

Table 5: Determination of the concentration of the samples.........................................................33

x
 ABBREVIATIONS AND ACRONYMS
PI: parallel import

Non PI: non parallel import.

WHO: World Health Organization

DRA: Drug Regulatory Authority

IDF: Import Declaration Form

KAPI: Kenya Association of Pharmaceutical Industries

KEMSA: Kenya Medical Supplies Agency

OTC: Over the Counter

PPB: Pharmacy and Poisons Board

UNICEF: United Nations Children Education Fund

ICH:International council of Harmonization.

USAID: United States Agency for International Development

MoH: Ministry of Health

HPLC: High performance liquid chromatography

Sp: Stationary phase

Mp: Mobile phase

xi
 CHAPTER ONE :INTRODUCTION.

1.1Background information.
Parallel importation refers to the practice of importing and selling genuine goods, typically

branded products, without the authorization of the intellectual property owner. These goods are

often obtained from a lower-priced market and then resold in a higher-priced market, taking

advantage of price differentials. Parallel imports are legal in some jurisdictions but may infringe

on intellectual property rights in others. The legal status and regulations surrounding parallel

importation vary globally, leading to debates about its impact on competition, consumer choice,

and intellectual property protection.

Parallel importation in the Kenyan market is influenced by factors such as the legal framework,

intellectual property considerations, and the balance between promoting competition and

protecting consumer interests.

The results of a random survey indicate that chemists in and Eldoret ,which stock these drugs,

exhibit a high degree of secrecy. Unauthorized importers often disregard the guidelines set by the

PPB and MoH, choosing to import medical substances with packaging that does not adhere to the

recommended standards. Many packs imported by these traders are in languages such as French,

Turkish,Parkistani, Arabic, Chinese, etc., posing challenges for consumers in reading and

understanding the provided instructions.

Some parallel importers sell medicinal products at prices lower than those of authorized

distributors, while others, motivated by corporate greed, sell these drugs at elevated prices, as

seen in Kapsabet and Eldoret.

1
In summary, the presence of parallel importation in the country leads to significant

consequences. Unauthorized importers have introduced counterfeit drugs into the national supply

chain through parallel importation, benefiting a select few at the expense of millions of innocent

users. Patients may not experience substantial benefits from lower prices, and also the

government incurs losses in revenue due to illegal importers evading import declaration fees

through collaboration with corrupt officers at the KRA and borders. Consequently, the Kenyan

government, in collaboration with relevant stakeholders, should diligently enforce parallel

importation rules established in September 2019 to ensure compliance and foster a fair playing

field.This project focuses on parallel imported of the following drugs;Diamicron MR is an

extended-release form of gliclazide, functioning as an oral antidiabetic agent by stimulating

insulin release from the pancreas. Natrilix SR, a sustained-release indapamide, acts as a thiazide-

like diuretic to treat hypertension and associated edema in heart failure. Atorvastatin, absorbed

rapidly in the gastrointestinal tract, is a statin medication widely used to lower cholesterol levels,

reducing the risk of cardiovascular events. Loperamide, well-absorbed in the gastrointestinal

tract, serves as an anti-diarrheal medication, alleviating symptoms of acute or chronic diarrhea.

Duphaston, containing dydrogesterone, is rapidly absorbed after oral administration and is

utilized in gynecological conditions, such as irregular menstrual cycles and hormone replacement

therapy. Understanding the pharmacokinetics, uses, and mechanisms of action for each

medication is crucial for their effective and safe application, and consultation with a healthcare

professional is recommended for personalized guidance.Top of Form

2
1.2Problem statement and Justification of the study.
The possibility of offering consumers reasonably priced pharmaceuticals through parallel importation

has been proposed. Critics then point out issues that come from reprocessing PI, citing the potential

for errors or ambiguity in the packaging and instructions as well as the degradation of some security

traceability features(Maskus, 2001). The question of stability is raised because most countries are in

different ICH stability zones than Kenya. Pharmaceuticals that are simultaneously imported from

different ICH stability zones carry a risk to public health because their quality in terms of long-term

stability is not guaranteed (González-González et al., 2022).

Furthermore, it allows pharmaceuticals of lower quality to get onto the market. This research

mostly attempts to evaluate the affordability and quality of parallel imported goods.

Price is a key factor to take into account while purchasing medication. Due to increased

competition among pharmaceutical companies and the availability of medications that are priced

above the means of most people, pharmaceutical companies have adopted access strategies to

lower the prices of their medications for specific market segments through parallel importation,

thereby competing with the patent holder's distribution channel and helping to bring down prices.

Because of this, it is crucial that the government shut down any openings that exploit to smuggle

in counterfeit medications, which have overtaken the market and are being offered for less

money. These inferior medications may cause unpleasant drug reactions or other negative effects

in patients who take them.

3
1.3 Research objectives.

1.3.1 General objectives.

I.To evaluate the pricing, quality and distribution pattern of atorvastatin,diamicron MR,Natrilix

SR,Duphaston and Imodium in Kapsabet and Eldoret Chemists.

II.To assay atorvastatin tablets in the laboratory using HPLC method.

1.3.2 Specific objectives.

I.To assess the retailing price differentials and price trends of the selected parallel imported

medicines.

II.To determine the proportion of outlets selling these selected parallel imported medicines.

III.To evaluate if the parallel importers observe the MOH and PPB guidelines while importing

these drugs

IV.To assay atorvastatin tablets in the laboratory using HPLC method.

1.4 Research questions.

I.Do pharmaceutical companies bring in sub-standard medicines through parallel importation?

II.Do selected parallel imported medicines comply with PPB and ICH guidelines?

III.What is the proportion of outlets selling and the detailing prices of these selected parallel

imported medicines?

IV.Does the assayed atorvastatin tablet comply with the set standards?

4
1.5 Significance of the study.
The study is important because it looks into the difficulties encountered in Kapsabet and Eldoret

during parallel importation. Furthermore, the study makes recommendations for how to address

the previously described issues with parallel imports.

Additionally, the study raises awareness among the drug-taking patients about the existence of

unlicensed drug importers who bring in less expensive but potentially dangerous items. Further

more, the report will help policymakers close the gaps that allow unauthorized importers to bring

illegal drugs into the country.

Pharmaceutical companies who are registered and suitable will gain from this study since it will

identify dishonest importers who bring in inferior items and sell them for less. This will help to

disband the toxic rivalries.

1.6 Scope of the study.

The research focused on the quality and affordability of selected parallel imported drugs in

Kapsabet and Eldoret. The drugs under study were atorvastatin,diamicron MR,Natrilix

SR,Duphaston and loperamide.

5
 CHAPTER TWO:LITERATURE REVIEW.

2.1 The concept of parallel importation.

Parallel import means that patented or marked goods are purchased in a foreign market and

resold in the domestic market. These are known as passive parallel imports.An active parallel

imports occur when foreign licensees enter the market in competition with the holder of the

patent or of the trade mark.

Parallel imports are allowed under section 58(2) of the Industrial Property Act. Parallel

importation regulations were approved in September 2006 as a result of multinational firms

using tiered pricing, or different prices, across national borders.

The aim of the plan is to enable lower-cost pharmaceutical goods into the country without

compromising their quality; parallel importation is by no means the same as allowing low-

quality medications into the country. Parallel importation allows Kenya to take advantage of

variances in medicine prices across several regional markets and acquire the pharmaceuticals at a

lower cost. It is an economic strategy, not a quality one. a reduced price on the market in Kenya.

PPB states that by putting this plan into practice, it hopes to lower the price of branded

pharmaceuticals by at least 65%, increasing accessibility to the drugs. Because the price

reductions result in lesser returns, it is also hoped that the parallel importation technique will

lessen the urge for counterfeit goods.

The challenge faced by parallel importations is to balance two types of economic efficiency:

dynamic efficiency, which deals with a system's ideal capacity to generate innovations, and static

6
efficiency, which results in a price reduction for customers. It is evident that these levels of

efficiency are not consistently comparable. Ensuring appropriate compensation for the owner of

intellectual property in the market where the product is first admitted for research and

development activities is the only way to achieve a healthy balance. However, there isn't an

undue chance that the patent holder will take advantage of the market.

2.2 Parallel importation of medicine in Kenya.

Section 58(2) of the Industry Property Bill, which was passed in 2001, made it legal to import

pharmaceuticals and other items used in the healthcare industry in parallel.

The Pharmacy and Poisons Act provides the basis for these regulations. With a few well defined

exceptions, the Regulations cover pharmaceuticals that are parallel imported and sold on the

Kenyan market. According to the regulations, unless an individual is incorporated as a limited

liability corporation, they are not permitted to import medicinal substances.

In addition, the medicinal material must have a valid market license in its country of origin, a

valid registration in Kenya, and a certificate of parallel importation issued by the individual

importing the item. The process for applying for a parallel import license and a certificate of

parallel importation is covered in great detail in the Rules. The Rules also address the import's

packing and labeling and grants authorized officers the authority to check properties and

pharmaceutical consignments at the port of entry.

The public's health and the general public are greatly endangered by the unauthorized importers

because they lack the necessary permits to handle pharmaceutical products.This industry involves a

large number of non-pharmacists. Because they smuggle drugs or bring them to the market, these

7
traders are frequently referred to as brief case traders. They smuggle drugs, including counterfeit

ones, in amounts not disclosed.(Thanthirige & associates, 2016)

2.3Effects of parallel importation of medicines and pharmaceutical

products in Kenya.
In Kenya, parallel importation has both advantages and disadvantages. It has aided the country in

making sure that the general population has access to enough medications. It has also assisted in

lowering the price of purchasing medication. Parallel importation is important in underdeveloped

countries, particularly when access to medications is restricted and the cost of those that are

available is high. Nonetheless, challenges arise when trying to use parallel imports to advance

public health and medication accessibility (Wanyoike Kariuki, 2020).

However,failure to adhere to the rules and regulations set has led to some challenges.By using

the IDF fee, many of these traders avoid paying the taxes that are supposed to be paid to the

government and to PPB and KRA. Additionally, some businessmen have discovered ways to

influence or buy off officials in order to issue import permits without authorization. They also

lack the necessary paperwork, such as certificates of analysis, to obtain an import permission

because their suppliers in Georgia, Turkey, and the Ukraine are prohibited from selling to

customers outside of their nations due to illicit trade.

The PPB's requirements on language on packs are frequently disregarded by importers, who also

frequently break the rules regarding what kinds of packs are allowed to be sold in Kenya. This is

why it is common to see packs without any wording in either English or Kiswahili.

The Turkish or Arabic writing on a number of the packs that these traffickers import into Kenya

compromises patient safety by making it difficult for users to understand how to take the

8
medications. In addition, parallel importers contend that their prices are far less than those of

authorized importers and wholesalers. This might be the case in certain circumstances, however

the patient rarely benefits from the price savings because the shop that buys the drugs will

normally maximizes his or her earnings by taking advantage of the large margins obtained from

purchasing these packs, but the patient will still receive the medications at the same cost as if

they were obtained from an authorized supplier.

This has been noted in a few of the hospitals in the county which buy drugs from other countries

and resell them for costs that are either higher than or equal to those set by the authorized

importer. Insurance patients are the primary audience for this.

2.4 Intellectual Property Act.

The government grants restricted rights known as intellectual property rights, or IPRs, for

particular concepts and artistic creations that are the product of human ingenuity. Patents give

innovators the right to stop competitors from developing, commercializing, or disseminating

their innovations for the duration of the protection period, which is normally 20 years from the

date of filing. For as long as they live plus 70 years, companies are granted a similar level of

protection by copyright, which forbids others from creating, marketing, or sharing their creative

works. Trademarks, on the other hand, grant the owner of the right to stop third parties from

using the same or confusingly similar marks and names on their goods.

IPRs are limited by the borders of each state because they are issued by the state. The "principle of

national exhaustion," which is applied by a number of countries, states that the exclusive rights of

IPR holders end after their first sale within their place of origin. It also suggests that intellectual

property rights holders are prohibited from importing similarly protected works of art that are

9
legitimately sold elsewhere. Under international exhaustion, which terminates rights upon first

sale anywhere, parallel imports might not be illegal. International fatigue as a global rule,

according to others, will enhance well-being by enabling consumers to take advantage of lower

prices across the board. Others argue that the welfare of many individuals will deteriorate under

a global system of international fatigue, especially for those residing in developing countries.

If a business can't set its prices apart, it will only be able to set one, and that price will almost

certainly be higher than what many customers are willing to pay. In an economy with low

marginal production costs, pricing discrimination makes sense. Of course, the ability to keep

market segments as distinct marketplaces is a requirement for price discrimination. This means

that in creative markets, there must be some exclusivity, which is usually accomplished through

strict enforcement of patents or other intellectual property rights. In our simple scenario with

zero marginal costs, competition would push the price to zero in every area if there was no

intellectual property protection.

Therefore, the application also requires that there be no arbitrage or leakage across segments.

2.5Safety , Quality and stability of drugs parallel imported.

To make sure that these pharmaceuticals are safe to use and do not pose any risks to the public, it

is necessary to verify the safety and quality of parallel imported drugs. Kenya must import

medications from countries that adhere to the same regulatory norms and procedures as the

Pharmacy and Poisons Board. This guarantees that the people may obtain and use these

medications, and that there will be fewer adverse effects on the population.

While certain parallel import medications might not meet the regulations' labeling criteria, other

quality requirements might still be met. The labeling, pamphlets, and product inserts for parallel

10
imported medications might occasionally have issues including; packaging, trade mark laws, and

language not used in Kenya.While these issues are real, there isn't enough proof to conclude that

they have an impact on the public's access to healthcare.

The storage of pharmaceuticals in relation to the necessary temperatures and climatic zones raises

additional concerns about the safety and quality of drugs that are imported in parallel. In Kenya,

where the temperature is 30°C, it is not permissible to import and utilize a medication product that

needs to be stored at roughly 42°C. If this were to happen, the drug's quality would decline.

The International Council for Harmonization states that the various Climate Zones for

Pharmaceutical Stability, depending on the climate of the country in which a new drug ingredient

or product will be sold: the stability of pharmaceuticals in terms of storage conditions with

fluctuating temperature and humidity must be met in order to submit for registration.

Pharmaceutical stability testing is necessary to demonstrate how a drug's quality changes when it is

exposed to changes in temperature, humidity, and, in certain cases, light. A product's appropriate

shelf life and suggested storage settings for samples are also determined by stability testing.

The ICH lists five distinct climate zones:

Zone I is temperate zone with temperature of 21°c

Zone II is subtropical/mediterranean,with temperature of 25°c

Zone III is hot and dry, with temperature of 30°c

Zone IV a; Zone IVb: Hot, humid, and tropical; hot, with increased humidity and temperature of

30°c (ICH, 2017)

11
Because different climate zones have different circumstances, drugs from one zone cannot be

imported or exported to another. Should a medication be imported from one zone to another,

there may be a risk to the population's health. If a product intended for tropical storage is kept in

a temperate climate, its shelf life is shortened and its quality is lost.

12
 CHAPTER THREE :RESEARCH DESIGN AND METHODOLOGY.

3.1 Introduction.
This chapter introduces the procedures used in each individual quality test parameter that was

performed. It also explain the kind of the research design adopted in this study, the chemicals,

drugs and equipment used.

3.2Study design
The researcher employed a comparative approach, comparing the original samples of atorvastatin

,Diamicron MR, Natrilix SR,Duphaston and Imodium with the parallel imported sample from the

pharmacies in Kapsabet and Eldoret.

13
3.3 Study area.
The study was conducted in Kapsabet town,Nandi County and Eldoret town ,Uasin Gishu.

14
3.4 Inclusion and exclusion criteria
The study employed both the inclusion and exclusion criteria to be able to only incorporate relevant

information as per the study objective.

3.4.1 Inclusion Criteria

Evaluation of the product's pricing, labeling,quality,drug content and storage instructions were

included in the study.

15
3.4.2 Exclusion Criteria
In the exclusion criteria parameters such as purity,expiration dates,batch numbers and dosage

will be excluded from this study.

3.5 Data collection

3.5.1 Research Instruments.

The guidelines provided by the WHO for conducting surveys on drug quality.

The PPB framework for parallel imports.

3.5.2 Sampling Procedure

Throughout the procedure, samples were taken from specific pharmacies located Kapsabet and

Eldoret by a mystery shopper who was of Kenyan heritage. The client behaved and dressed

suitably to portray himself as a "regular shopper" from the area where the store is located.

3.6Ethical considerations
To avoid impeding the acquisition of pertinent data, the identities of the pharmacies and chemists

were concealed, even though no ethical permission was requested to conduct the study.

3.7 Laboratory analysis of atorvastatin.

3.7.1 HPLC Method development.

During the method development,we focused on choosing a selective and simple mobile phase

and appropriate chromatographic in order to achieve a successful,rapid,reproducible and

effective separation.

16
Shim-pack XR-ODS II 75 mm by 3mm ,2.3um was selected.This is a C18 column that acted as

the stationary phase for the analysis.

An isocratic mobile phase containing 43%acetonitrile,and 0.05%v/v formate at pH 4.1 and

HPLC water was used.

Diluent used was Acetonitrile: Solution A in the ratio of 1:1. Solution A consisted of 2.405g

citric acid in 250ml water,adjusted to pH 7.4 using ammonium hydroxide solution.

Flow rate used for the assay was1ml/min with injection volume of 10ul.

Detection wavelength was 245 nm and column temperature of 30°c.

3.7.2Reagents and chemicals.

Atorvastatin working standard.

Tablets were purchased from local pharmacy manufactured by Pfizer pharmaceuticals (lipitor).

HPLC water.

HPLC grade acetonitrile.

Formate

Ammonium hydroxide

Analytical balance

pH meter.

Regenerated cellulose 0.45um strings filters.

17
3.7.3Procedure
Preparation of the reference standard of atorvastatin.

10ml of the standard was dissolved in 20ml of diluent solution and the mixture transferred to a

20 ml volumetric flask. Give it a thorough shake to combine

From the standard solution,several standard concentrations were obtained for analysis:

0.008mg/ml, 0.004 mg/ml,0.002mg/ml, 0.001mg/ml, 0.0005mg/ml.

Preparation of sample of atorvastatin parallel import.

The weights of 20 tablets were measured using an analytical balance and the results recorded.

The tablets were then placed in a mortar and crushed to a fine powder by a pestle.

64.5mg of the sample was collected and dissolved in 50ml diluent solution.

0.4ml of the resulting mixture was obtained and topped up to 20ml.

3.7.4 Weight variation.

Apparatus and Materials:

Electronic balance, weighing boats, tablets, capsules.

20 tablets were weighed. The average weight was determined. Then, tablets was weighed

individually and for each tablet, the percentage of deviation of its weight from the average

weight was determined.

18
 CHAPTER FOUR:RESULTS AND DISCUSSION.

4.1 The determination of the proportion of chemists selling parallel

imported non-complaint drugs.

A total of 27 pharmacies and chemists were included by the survey, and it was determined what

percentage of these establishments sold the non-complaint parallel imported medications that

were chosen for this investigation.

Results.

Lipitor 10mg:

Price: PI at 1300, non-PI at 3000.

Distribution: 18.51% of outlets have PI priced 30% less than non-PI.

Diamicron MR 60mg:

Price: PI sold at 2280 (60 tablets @ 38 KSH), non-PI at 1950 (30 tablets @ 65).

Distribution: 14.81% of outlets have PI priced 14.47% more than non-PI.

Natrilix SR 1.5mg:

Price: PI sold at 1440 (48 per tablet), non-PI at 1350 (45 per tablet).

Distribution: 18.51% of outlets have PI priced 6.25% more than non-PI.

Duphaston 10mg:

Price: PI sold at 2200 (110 per tablet), non-PI at 1800 (90 per tablet).

Distribution: 11.1% of outlets have PI priced 18.18% more than non-PI.

19
Imodium 2mg:

Price: PI at 350, non-PI at 330.

Distribution: 7.40% of outlets have PI priced 5.71% more than non-PI.

These insights provide a snapshot of the pricing dynamics and market share for each

pharmaceutical product across different outlets.

From the data collected in Kapsabet and Eldoret chemists:out of 7 chemists visited in

Kapsabet,non of them had stocked the parallel imported drugs.

20 chemists were visited in Eldoret.

4.2 Pricing of the parallel imported and original drugs in Eldoret.

Table 1: Pricing of the parallel imported and original drugs in Eldoret.

DRUGS. Types Price(PI) Tablets(PI Price(Non Percentage
and Non PI) of outlets

PI) with the PI

Lipitor PI 1300 30 3000 75%

NonPI - - -

Diamicron PI 2280 60 - 85%

MR

Non PI 1950 30 65

20
 Natrilix PI 1440 48 - 70%
SR

Non PI 1350 45 -

Duphaston PI 2200 110 - 50%

Non PI 1800 90 -

Imodium PI 350 - 330 40%

Non PI - - -

Bar graph: Price differentials of the selected drugs in Eldoret.

Figure 1: Price differentials of the selected drugs in Eldoret.

21
4.3Results of assay of atorvastatin using HPLC.

4.3.1 Weight variation for atorvastatin

Table 2: Weight variation for atorvastatin

Tablet Weight in mg Deviation from the mean
weight in mg

1 104.9 1.56

2 104.7 1.36

3 103.5 0.16

4 104.0 0.66

5 103.8 0.46

6 102.0 -1.34

7 101.5 -1.84

8 100.6 -2.76

9 100.3 -3.04

10 104.7 1.36

11 102.9 -0.44

12 103.0 -0.34

13 103.4 0.06

14 102.0 -1.34

15 101.1 -2.24

16 104.1 0.76

22
 17 103.0 -0.34

18 98.5 -4.84

19 101.6 -1.74

20 102.2 -1.14

Average weight 103.34mg

Range (difference between the maximum and minimum): 104.9 - 98.5 = 6.4mg.

Calculation of the mean weight:

Adding up all the weights and dividing by the number of tablets (20):

{Mean} = 2066.8÷20

Mean=103.34mg

The compliance with the weight variation standard is crucial for ensuring the uniformity and

potency of the atorvastatin tablets. The narrow range of deviations observed in the study

underscores the precision and reliability of the manufacturing process, contributing to the overall

quality of the medication.

23
4.4.2Assay of atorvastatin.

Table 3: Assay of atorvastatin.

Number Concentration,mg/ml Peak area

Standard 1 0.0005 6123

Standard 2 0.001 18599

Standard 3 0.002 41270

Standard 4 0.004 90780

Standard 5 0.008 193408

Sample 1 2.830 62771

Sample 2 2.592 51834

Sample 3 2.617 52928

In the preparation of the reference standard, it's important to note the meticulous steps taken to

ensure accuracy. The 10ml of the standard dissolved in 20ml of diluent solution signifies a

concentration adjustment, and the transfer to a 20ml volumetric flask indicates precision in

volume control. The thorough shake post-transfer guarantees uniformity in the solution.

The subsequent creation of various standard concentrations (0.008mg/ml, 0.004mg/ml

0.002mg/ml, 0.001mlg/ml 0.0005mg/ml) allows for a calibration curve. This curve aids in

determining the relationship between concentration and response during the analysis, enhancing

the accuracy of the results obtained from the subsequent testing.

24
In the preparation of the atorvastatin parallel import sample, the use of an analytical balance to

measure the weights of 20 tablets ensures consistency in the sample size. Crushing the tablets into a

fine powder facilitates the dissolution process, ensuring a homogeneous mixture for analysis.

Collecting a specific weight (64.5mg) of the sample and dissolving it in 50ml of diluent solution

speaks to the precision required in pharmaceutical analysis. The subsequent step of obtaining

0.4ml from this mixture and adjusting the volume to 20ml ensures the creation of a sample

solution with a concentration suitable for analysis, aligning with the standard concentrations

previously prepared.

Overall, these detailed steps in the preparation process are crucial for maintaining accuracy,

precision, and repeatability in pharmaceutical analysis, guaranteeing reliable results for assessing

the quality of the atorvastatin parallel import sample.

25
4.4 Discussion
The Pharmacy Poison Board regulates all medications, both those produced in the country and

those imported. Figure below shows that the country is in stability zone IV, and the board

recommends keeping prescription drugs at a stable temperature of less than 30°C.

Table 4: ICH Climatic zones

26
Figure 2: ICH Climatic zones

ICH and PPB Labeling requirements.

PPB states that parallel imported medications must have the exact same formulation, proprietary

name, packaging, strength, labeling, and quality, efficacy, and safety standards as the registered

reference medication that is currently available on the market and registered in Kenya.

The labels for the medications should also be in English or Kiswahili, so that both the people

using the products and medical experts may comprehend them. This will compel patients and

medical professionals to follow the printed instructions on the pharmaceutical pack, which

probably include information about what foods to avoid, dosages, and expiration dates in

addition to instructions for taking the prescription.

27
Figure 3. Figure Showing parallel import of Duphaston.

28
Figure 4 Showing imodium parallel import.

29
Figure 5 Showing Diamicron MR parallel import

30
Figure 6 Showing Natrilix SR parallel import.

31
4.5 Analysis of atorvastatin using HPLC method.

Figure 7: Graph of assay of atorvastatin using HPLC.

Y=mx+c

Y=44675x- 63989

Gradient =44675

Y intercept= -63989

32
Table 5: Determination of the concentration of the samples.
Sample Concentration,mg/ml Concentration*10^-3

1 2.838 0.002838

2 2.592 0.002592

3 2.617 0.002617

Average= 0.002682 + 0.002605

=0.005425÷2

=0.0026045mg/ml

Calculation of the dilution factor

(50×20)÷0.4 =2500

Actual yield =0.0026045×2500

=6.51125mg

Calculation of theoretical yield

If 102.5mg is in 10mg of drug

64.5mg is in ?

33
(64.5×10)÷102.5 mg

=6.2927mg

Percentage yield :

(Actual yield/theoretical yield) ×100%

(6.51125mg/6.2927)×100%

=103.47%

The content of the active pharmaceutical ingredient found in atorvastatin parallel

import tablets was found to be 103.47% ,which was within the normal range as prescribed by USP.

USP ranges for atorvastatin calcium tablets :NLT 90.0% and NMT 110.0%.

Ensuring the safety and efficacy of a drug requires keeping the active pharmaceutical ingredient

(API) within the designated range. Positive findings include the API content of atorvastatin

parallel import tablets, which is 103.47% within the USP's (United States Pharmacopeia) normal

range. By upholding these criteria, the product's quality and consistency are guaranteed, allowing

patients to benefit from its intended therapeutic effects. To maintain the dependability of

pharmaceuticals and protect public health, the pharmaceutical sector must implement strict

quality control procedures.

34
 CHAPTER FIVE:CONCLUSIONS AND RECOMMENDATION.

5.1 Conclusion.

Drugs must be properly registered before being sold, according to PPB regulations. The quality

of the drugs—both quantitatively and qualitatively—is one of the factors taken into account

before registration. The medication must have an accurate label that specifies its storage

requirements. The correct labeling of all aspects, including lot number, manufacturing, and

expiry dates, is done while using the national language of Kiswahili or English.

Nevertheless, none of the medications in the sample had labels in either English or Kiswahili,

and none had expiration dates.

Proving of the drugs was also an issue observed during the market survey.The parallel imports

were observed to be more costly that the non -parallel imports.

From the laboratory assay of the parallel import of atorvastatin tablets,it was observed that the

drug content was 103.47% ,the value falls within the normal USP ranges for atorvastatin :90.0%-

110.0%

35
5.2 Recommendation
To address the challenge of parallel importation of drugs that do not comply with set standards, a

multifaceted approach is essential. First and foremost, regulatory frameworks must be

strengthened and updated to encompass all aspects of pharmaceutical imports. This includes the

implementation of stringent product quality standards and certification processes by the PPB and

MOH.

Concurrently, border controls should be enhanced through investments in advanced screening

technologies and comprehensive training for customs officials. Collaborating with international

agencies to share information on suspect shipments is crucial in fortifying these measures.

Penalties for individuals and entities involved in parallel importation of substandard drugs should

be significantly increased to serve as a deterrent. Swift and effective legal actions against

offenders are imperative to uphold the integrity of the regulatory framework.

Simultaneously, public awareness campaigns should be launched to educate consumers about the

inherent risks associated with purchasing non-compliant drugs.Emphasizing the importance of

verifying the authenticity and source of pharmaceutical products is vital in empowering

consumers to make informed choices.

Ensuring transparency in the pharmaceutical supply chain is another key aspect. This involves

implementing traceability systems to monitor the entire supply chain from manufacturing to

distribution. Regulating wholesalers and distributors is essential to guarantee compliance with

established standards. Collaborating with

pharmaceutical manufacturers to strengthen the supply chain and monitor distribution channels

can be achieved through partnerships and industry self-regulation.

36
International collaboration is paramount in addressing the issue on a global scale. Working

closely with neighboring countries and international organizations facilitates the sharing of

intelligence and coordinated efforts. Participation in international agreements and initiatives

focused on combating illegal drug trade further bolsters these collaborative efforts.

Regular audits and inspections of pharmaceutical facilities, both domestically and

internationally, are vital to ensure ongoing compliance with quality standards. Joint audits with

regulatory bodies from other countries enhance the effectiveness of these inspections.

Leveraging technology, such as track-and-trace systems and blockchain, can be instrumental in

monitoring the movement of pharmaceuticals throughout the supply chain.

Additionally, whistleblower protection mechanisms should be established to encourage

individuals to report illegal activities related to parallel drug importation. Incentivizing

whistleblowers to come forward with information strengthens the overall regulatory framework.

By implementing this comprehensive set of measures, a more robust and resilient system can be

established to curb the parallel importation of non-compliant drugs, ultimately safeguarding

public health.

37
Figure 8 Chromatogram of the diluent

38
Figure 9 .Chromstogram of the sample.

39
Figure 10 Chromatogram of the standard.

40
 REFERENCES
International Indigenous Biodiversity Forum in its opening statement at the Convention on

Biological Diversity ad hoc open-ended working group on access and benefit sharing, Granada,

30 Jan-3 Feb 2006, at http://www. ipch.org/pipermall/ipcb-net_ipch.org/2006 (12 May 2007)

T Janke. Minding Culture: Case Studies on Intellectual Property Rights and Traditional Cultural

Expressions - The Carpets Case at http://www.wipo. int/tk/en/ (28 November 2009), pp. 71-72

Monsanto co. v Kamp, Jahn & US Commissioner of Patents 360 F.2d 499, 146 U.S.P.Q. 431,

123 U.S. App. D.C. 365 (1965)

Morel, C. M., Acharya, T., Broun, D., Dangi, A., Elias, C., Ganguly, N. K., ... & Yun, M. (2005).

Health innovation networks to help developing countries address neglected diseases. science,

309(5733), 401-404.

Ngamau. E. (2016) Challenges Facing Marketing of Pharmaceutical Products in Kenya: A Case

Study of selected distributors in Kenya. Nairobi, KE: United States International

University, Unpublished MBA Thesis. Ngamau. E. (2016) Challenges Facing Marketing of

Pharmaceutical Products in Kenya: A Case

Study of selected distributors in Kenya. Nairobi, KE: United States International

University, Unpublished MBA Thesis.

Okinyi, J. (2019). Retrieved from https://www.capitalfm.co.ke/eblog/why-the-govt-must-curb-

parallel-importation-of-

medicines/#:~:text=Parallel%20trade%20or%20importation%20of,Industrial%20Property%20A

ct%20of%202001.

41
Museum of New Zealand Te Papa Act 1992, http://www.legislation.govt.

nz/libraries/contents/om_isapi.dll?clientID-553312052&infobase-pa 1 statutes (11 December

2008)

S Nelson-Harrison et al., "Ethnobotanical research into the 21st century', in Iwu & Wooton eds,

Ethnomedicine & Drug Discovery, Elsevier, Amsterdam, 2002

JA Orwa et al. "The use of Toddalia asiatica (L) Lam. (Rutaceae) in traditional medicine practice

in East Africa" at http://www.sciencedirect.com (20 January 2009)

M Skrydstrup. "Towards Intellectual Property Guidelines and Best Practices for Recording and

Digitizing Intangible Cultural Heritage" Prepared for the World Intellectual Property

Organisation (WIPO) Oct. 2006

T Stangeland, SS Dhillion and H Reksten. "Recognition and Development of TM in Tanzania" in

J Ethnopharmacology 117(2)(2008): 290-299 Sudanese Traditional Music Archive at

http://www2.uofk-edu/index.

T Swanson and T Goeschl. "Property Rights issues involving plant genetic resources:

Implications of ownership of economic efficiency" in Ecological Economics 32(1) (2000)

JRS Tabuti. "Herbal medicines use in the treatment of malaria in Budiope County, Uganda" in J

Ethnopharmacology 116(1) (2008):33-42

Department of Pharmaceutical Chemistry, I. Horbachevsky Ternopil National Medical

University, Maidan Voli 1, 46001 Ternopil, Ukraine

42