DETERMINATION OF THE PRICE, DISTRIBUTION PATTERN AND QUALITY

OF SEVERAL PARALLEL IMPORTED DRUG PRODUCTS IN GITHURAI

CHEMISTS

BY

KEVINCOLLINS KIPKIRUI

BPHARM/2018/86362

A RESEARCH PROJECT SUBMITTED IN PARTIAL FULFILLMENT OF THE

REQUIREMENTS OF THE AWARD OF DEGREE OF

BACHELOR OF PHARMACY OF

MOUNT KENYA UNIVERSITY

SCHOOL OF PHARMACY

DEPARTMENT OF PHARMACEUTICAL SCIENCES

MOUNT KENYA UNIVERSITY

MAY 2024
 DECLARATION

I declare that this project is my original work and has not been submitted to any institution

for award of degree or diploma.

KEVINCOLLINS KIPKIRUI

BPHARM/2018/86362

Signature: ………………………. Date : ………………………….

Supervisor's approval

I can hereby confirm that this project has been conducted and submitted with my approval as

the student supervisor.

DR.EPA TWAHIRWA

Signature: ………………………. Date : ………………………….

School of Pharmacy

Department of Pharmaceutical Sciences

Mount Kenya University

ii
 DEDICATION

I dedicate this project to my precious adoring parents Rosemary Chepngeno Koros and Eric

Arap Keter{deceased},my siblings Kelvinian Tonny Kiprono and Keithivy Chelangat Keter

for their love and relentless unwavering and financial support towards the accomplishment

of this project.

iii
 ACKNOWLEDGMENT

First,I'm grateful to the Almighty creator God,who made me in his own image and

likeness,for the gift of life and good health.His guidance throughout my life in school as well

as starting and completing my study project.Moreover,I'm sincerely grateful for giving me

the gift of wisdom and understanding throughout the course of my 5-year degree program and

research project.

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

assistance and support throughout this study.Last but not least,I would like to appreciate my

laboratory technician Mr.Clement Wangui for his assistance,time and dedication to ensure I

carried out the practical I intended to do in this project.His insight was very beneficial in my

completion of this project.I'm truly delighted and pleased.

I would also like to appreciate and acknowledge my fellow classmates and colleagues.We

have passed through this journey together.

My appreciation also goes to the School of Pharmacy and Department of Pharmaceutical

chemistry for the support in laboratory analysis and results interpretation.

iv
 ABSTRACT
The study developed into the pharmaceutical industry's parallel importation practices,
especially in SIX sample drugs, which are Artovastatin, Cataflam,Diamicron
MR,Rosuvastatin 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 30 pharmacy 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

TABLE OF CONTENTS..........................................................................................................vi

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

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

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

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

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

1.2 Problem statement and justification of study.......................................................................3

1.3 Research objectives..............................................................................................................3

1.3.1 General objectives.............................................................................................................3

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

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

1.5 Significance of study............................................................................................................4

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

CHAPTER TWO.......................................................................................................................6

LITERATURE REVIEW...........................................................................................................6

2.1 Concept................................................................................................................................6

2.2 Parallel importation of medicine in Kenya..........................................................................6

2.3 Effects of parallel importation of medicines and pharmaceutical products in Kenya.........7

2.4 Intellectual Property Act......................................................................................................8

2.5 Safety , Quality and stability of drugs parallel imported.....................................................9

vi
CHAPTER THREE..................................................................................................................11

RESEARCH DESIGN AND METHODOLOGY...................................................................12

3.1 Introduction........................................................................................................................12

3.2 Study Design......................................................................................................................12

3.4.1Inclusion Criteria..............................................................................................................14

3.4.2Exclusion Criteria.............................................................................................................14

3.5 Data Collection...................................................................................................................15

3.5.1Research Instruments.......................................................................................................15

3.5.2Sampling Procedures........................................................................................................15

3.6 Ethical considerations........................................................................................................15

3.7 Laboratory analysis of Artovastatin...................................................................................15

3.7.1 HPLC Method Development...........................................................................................15

3.7.2 Reagents and chemicals..................................................................................................16

3.7.3 Procedure.........................................................................................................................16

3.7.4 Weight variation..............................................................................................................17

CHAPTER FOUR: RESULTS AND DISCUSSION..............................................................18

4.1 The determination..............................................................................................................18

4.2 Pricing of the parallel and original drugs in Githurai town...............................................20

4.3 Results of assay of Artovastatin using HPLC....................................................................23

4.3.1 Weight variation for Artovastatin...................................................................................23

4.4Assay of Artovastatin..........................................................................................................24

4.5 Discussion..........................................................................................................................25

CHAPTER FIVE: CONCLUSION AND RECOMMEDATION............................................36

5.1 Conclusion..........................................................................................................................36

5.2 Recommendations..............................................................................................................36
vii
REFERENCES.........................................................................................................................40

viii
 LIST FIGURES

Figure 1 : Prices of the Original (Non parallel) and parallel imported drugs in Githurai Town

..................................................................................................................................................21

Figure 2 : ICH climatic zones..................................................................................................26

Figure 3 : Figure showing parallel import of Norvasc 5mg.....................................................27

Figure 4 : Showing parallel import of Duphaston....................................................................29

Figure 5 : Showing parallel import of Cataflam......................................................................31

Figure 6 : Showing parallel import of Diamicron-MR............................................................32

Figure 7 : Analysis of Artovastatin using HPLC method........................................................33

Figure 8 : Graph of assay of Artovastatin using HPLC...........................................................33

ix
 LIST OF TABLES

Table 1 : Pricing of the parallel and original drugs in Githurai town......................................20

Table 2 : Number of pharmacy outlets that dispense the six parallel imported drug samples in

Githurai town..........................................................................................................................21

Table 3 : Weight Variation for Artovastatin............................................................................23

Table 4 : Assay of Artovastatin................................................................................................24

Table 5 : ICH climatic zones....................................................................................................26

Table 6 : Determination of the concentration of the samples..................................................34

x
 ABBREVIATIONS AND ACRONYMS

TRIPS Trade related aspects of intellectual property rights

PI Parallel imports

PPB Pharmacy and poisons board

KRA Kenya revenue authority

UV-VIS Ultra violet visible spectrophotometer

xi
 CHAPTER ONE:INTRODUCTION

1.1 Background information

Parallel importation refers to the practice of importing and selling genuine goods, without

authorization of the original owner.The goods which are involved in the practice are known

as parallel imports.Medicines and drugs are pharmaceutical products which are the goods

which are normally involved in this practice.The practice of parallel importation was majorly

introduced to caution majority of the population from the drug manufacturers who used

monopoly to raise price of the drugs,hence making them unaffordable and inaccessible

{Ganslandt, Mattias;Maskus,2004}.The rights to the good is involved gray market is known

to end once the first consignment of the goods has been successful distributed.This is under

exhaustion law .

Parallel importation in Kenyan market is influenced by factors like legal framework,

intellectual property considerations and the balance between promoting competition and

protecting consumer interests.

Secrecy is involved in results of random survey indicated in chemists in Githurai.Guidelines

set by PPB and MOH, are meant to be adhered to but unfortunately unauthorized suppliers

tend to disregard them and import medical supplies whose packaging does not adhere to

recommended standards.Most of packages most challenges the consumers in reading and

interpreting the product instructions because they are written in foreign languages ie

Turkish,Arabic,Chinese,French,Parkistani.

Some parallel importers sell medicinal products at lower prices compared to those of

authorized distributors.Others sell them at higher prices due to greed as documented in

Githurai.

Parallel importation has led to significant Unauthorized personells have introduced

counterfeit drugs through parallel importation, benefiting the selected few out of the
1
many.Due to lowered prices,the patients don't experience its benefits and as well as the

government incur loses in revenue due to illegal importers evading import declaration fees

through collaboration with corrupt officers at KRA and borders.The Kenyan government

should ensure the enforcement of parallel importation rules established in 2019 in

collaboration in September 2019 to enforce compliance and a fair playing field.This project

focuses on following drugs:Artovastatin, is a statin medication rapidly absorbed in the

gastrointestinal tract which reduces cardiovascular effects.It lowers cholesterol levels as

well.Diamicron-MR is an extended release of gliclazide, functioning as an oral antidiabetic

agent stimulating insulin increase from pancreas.Duphaston, containing dydrogesterone,

rapidly absorbed after oral administration and utilized in gynecological conditions such as

irregular menstrual cycles and hormone replacement therapy.Cataflam, famously known as

Diclofenac is used to relieve mild to moderate pain and swelling (inflammation) from various

conditions such as headache, dental pain, menstrual cramps, and muscle aches. Norvasc

tablets are a prescription medicine to treat high blood pressure (hypertension), and certain

types of chest pain (angina) and blocked arteries of the heart (coronary artery disease).

Coveram is a new fixed combination of an angiotensin converting enzyme inhibitor,

perindopril, and a calcium antagonist, amlodipine. This new medication is indicated for the

treatment of arterial hypertension and or stable coronary heart disease.Rosuvastatin, sold

under the brand name Crestor among others, is a statin medication, used to prevent

cardiovascular disease in those at high risk and treat abnormal lipids. It is recommended to be

used together with dietary changes, exercise, and weight loss. It is taken orally.Understanding

the pharmacokinetics,uses and mechanism of action for each medication is critical for their

safe and effective application and also helps in consultation with health professionals needed

for personnel guidance.

2
1.2 Problem statement and justification of 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.

1.3 Research objectives

1.3.1 General objectives.

i. To evaluate the pricing, quality and distribution pattern of

Artorvastatin,DiamicronMR,Cataflam,Duphaston and Rosuvastatin in Githurai

Chemists.
3
 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 in Githurai town.

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?

1.5 Significance of study

The study is important because at various difficulties encountered due to parallel importation

in Githurai. In addition, the study makes recommendation on how to address the previously

prescribed issues with parallel imports.

It also raises aware patients on medication that there is existence of unlicensed drug importers

who bring in less expensive items which are dangerous items. This study will help

policymakers make correct choice by closing in the gaps that allow unauthorized importers to

bring in illegal drug products into the country.

4
Pharmaceutical industries which are registered will gain from this study because it will help

identify dishonest importers who bring in less expensive items and sell them for more money.

1.6 Scope of study

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

in Githurai. The drugs under investigation were as follows Cataflam,Diamicron-

MR,Norvasc,Duphaston,Coveram and Rosuvastatin.

5
 CHAPTER TWO

LITERATURE REVIEW

2.1 Concept

Parallel importations refer to the purchase of trademarked or products that are already

patented in a different country then export to another country or market for resale. Parallel

importation is allowed as per section 58(2) of the industrial property act (Fink & Maskus,

n.d.). The guidelines governing the parallel importation were for the first time approved in

the month of September of the year 2006 due to the differences in prices that existed between

the countries globally as set by the multinational companies. Parallel importation is not only

the allowing in of the counterfeit products such as drugs in the countries but only bringing in

drugs that are cheaper without compromising the quality as directed by the parallel

importation policy (Jackline Irene Muthoni Nyaga, 2009).

Parallel importation indeed is not a quality issue but one of commercial in nature, it allows

the country to take advantage of price differentials of drugs in different geographic markets to

avail the drugs cheaply within the Kenyan market. According to PPB (2014), through the

implementation of this policy, PPB anticipates bringing down the prices of branded medicine

by at least 60 percent; this is expected to make the drugs affordable (Wanyoike Kariuki,

2020).Other benefits expected to accrue following the implementation of the parallel

importation policy is the reduction of temptation for counterfeits due to diminished returns

attributed to the reduction in prices (Ozawa et al., 2018).

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
6
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 traders are

frequently referred to as brief case traders. They smuggle drugs including counterfeit ones, in

amounts not disclosed.(Thanthirige & associates, 2016)

2.3 Effects 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.Moreover,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,
7
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 kind of packs

are allowed to be sold in Kenya. This is why it is common to see packs without any names in

either English or Kiswahili. The Turkish or Arabic writing ie, foreign languages, 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 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 and health clinics within the Githuraii

town, located in Kiambu 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
8
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 10 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.

2.5 Safety , 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
9
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

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 and Zone IVb: Hot, humid, and

tropical; hot, with increased humidity and temperature of 30°c (ICH, 2017) . Since 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.

10
 CHAPTER THREE

RESEARCH DESIGN AND METHODOLOGY

3.1 Introduction

This chapter introduces the procedures used in each individual quality and parameter that was

performed in study.In addition,it also explains the research design adopted in

study,chemicals, equipment and drugs used during the study.

3.2 Study Design

The researcher employed a comparative approach whereby there is comparing of original

imported drug samples of Cataflam, Diamicron-MR, Norvasc, Duphaston, Coveram and

Rosuvastatin with parallel imported samples from the pharmacists surveyed in Githurai.

3.3 Study area

The study was conducted in Githurai town,which is divided into two sub-towns ie Githurai 44

and Githurai 45.

11
12
3.4Inclusion and exclusion criteria

The study employed both the inclusion and exclusion criteria to be able to incorporate

relevant data as per the study objective.

3.4.1Inclusion Criteria

Labelling, quality,drug content, evaluation of drug samples prices and storage instructions

were included in the study.

3.4.2Exclusion Criteria

Exclusion parameters like expiry dates,batch numbers, purity and dosage will be excluded in

this study.

13
3.5 Data Collection

3.5.1Research Instruments

The guidelines provided by the WHO for conducting surveys in Githurai town on drug

quality.

The PPB framework for parallel imports used in this study.

3.5.2Sampling Procedures

Throughout the procedure,samples were taken from various pharmacies all over Githurai

town by a mysterious shopper who was of Kenyan heritage.The client behaved well and

dressed appropriately to portray himself as a "regular shopper"from the area where the store

is collected.

3.6 Ethical considerations

The identities of pharmacies and chemists were concealed to avoid impeding the acquisition

of data even though no ethical consideration was requested for this study.

3.7 Laboratory analysis of Artovastatin

3.7.1 HPLC Method Development

In order to achieve a successful,rapid,effective and reproducible separation then this

laboratory analysis should choose a suitable,selective and simple mobile phase and also an

appropriate chromatographic.

Shim-pack XR-ODS II 75mm by 3mm,2.3micrometres was selected.This is a C18 column

which acted as the stationary phase for the analysis

An isocratic mobile phase mixture contained 43% acetonitrile and 57% formic acid which

both solutions added upto about 350ml .This solutions were mixed together in a closed

bottle.HPLC water was also used.

Diluent used was 43%acetonitrile and 57%formic acid(with water) and then adjusted to pH of

7.4 by Ammonium hydroxide.

14
Flow rate used for assay was 1ml/min with injection volume of 10microlitres.

Detection wavelength was 245nm and column temperature of 30°C

3.7.2 Reagents and chemicals

Atorvastatin working standard.

Tablets were purchased from local pharmacy manufactured by Pfizer pharmaceuticals

(Artovastatin tabs).

HPLC water.

HPLC grade acetonitrile.

Formate{formic acid}

Ammonium hydroxide

Analytical balance

3.7.3 Procedure

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 and topped up to the mark.A thorough shake was given so that the

solutions fully mixed together.

From the standard solution, several standard concentrations were obtained for analysis;which

are as follows 0.08mg/ml, 0.04 mg/ml,0.02mg/ml, 0.01mg/ml

Preparation of sample of Artovastatin 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 in 50 ml
volumetric flask.

15
0.5ml of the resulting mixture was pippeted and topped up to the mark of 20ml volumetric
flask.

3.7.4 Weight Variations

Apparatus and materials

Electronic balance,

20 Artovastatin tablets and

An Analytical Balance.

Procedure

20 tablets were weighed.

The average weight was determined.

Tablets were weighed individually and for each tablet the deviation of its weight from the

average weight was determined.

16
 CHAPTER FOUR: RESULTS AND DISCUSSION

4.1 The determination of the proportion of pharmacy outlets selling parallel-imported

drugs

Total of 30 chemists and pharmacies were included in the study survey.It was determined

what percentage of these 6 drug samples were sold to the non-complaint parallel imported

medications that were chosen for the study.

Results

1.Cataflam 50mg

Price:Non PI at sh 7000

PI is at sh 6000 which means it is14.3% less than non-PI

80% of outlets with PI

2.Diamicron 60mg

Price:Non-PI=sh 1200

PI=sh 1200

60% of outlets with PI

3.Norvasc 5mg

Price:Non-PI=sh 2400

PI=sh 2400

66.67% of outlets with PI

4.Duphaston 10mg

Price:Non-PI=sh2000

PI=sh 1800 which means it is 10% less than non-PI

17
85% of outlets with PI

5.Coveram 50mg

Non-PI=sh 3600

PI=sh 2250 which means it is 37.5% less than non-PI

10% outlets with PI

6.Rosuvastatin 10mg

Non-PI=Didn't find any

PI =sh 2500

50% outlets with PI

From the above results,this shows the price dynamics in Githurai town in different

pharmaceutical outlets for each drug product.

A totol of 30 chemists visited in Githurai town.

18
4.2 Pricing of the parallel and original drugs in Githurai town

Table 1 : Pricing of the parallel and original drugs in Githurai town

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

in Kshs Non PI) PI) in Kshs outlets with the PI

Cataflam PI 6000 30 - 80%

Non PI - - 7000

Diamicron-MR PI 1200 60 - 60%

Non PI - 30 1200

Norvasc PI 2400 30 - 66.77%

Non PI - 30 2400

Duphaston PI 1800 60 - 85%

Non PI - 75 2000

Coveram PI 2250 100 - 10%

Non PI - 50 3600

Rosuvastatin PI 2500 30 - 33.33%

Non PI - - -

19
Bargraph: Prices differential of the selected drugs in Githurai

8000

7000

6000

5000

4000 PRICES (PI)

PRICES (NON-PI)
3000

2000

1000

0
Cataflam Diamcron-MR Norvasc Duphaston Coveram Rosuvastatin

Figure 1 : Prices of the Original (Non parallel) and parallel imported drugs in Githurai

Town As illustrated above.

Price(PI)
4.3

Cataflam Diamicron-MR Norvasc

Duphaston Coveram Rosuvastatin
Number of pharmacy outlets that dispense the six parallel imported drug samples in

Githurai town

20
Table 2 : Number of pharmacy outlets that dispense the six parallel imported drug

samples in Githurai town

DRUGS

CHEMISTS Cataflam Diamicron- Norvasc Duphaston Coveram Rosuvastatin

MR

1 ✓ ✓ ✓ × ✓ ×

2 × ✓ ✓ ✓ × ×

3 × ✓ ✓ ✓ ✓ ×

4 ✓ ✓ ✓ ✓ × ×

5 ✓ ✓ × ✓ × ×

6 ✓ ✓ × ✓ × ×

7 ✓ ✓ ✓ ✓ ✓ ×

8 ✓ × ✓ ✓ × ×

9 ✓ × ✓ ✓ × ×

10 ✓ × ✓ ✓ ✓ ×

11 ✓ ✓ ✓ ✓ × ×

12 ✓ ✓ × × × ×

13 × × ✓ ✓ × ×

14 ✓ × ✓ ✓ × ×

15 ✓ × ✓ ✓ × ×

16 ✓ × × ✓ ✓ ×

17 ✓ ✓ ✓ ✓ × ×

18 ✓ × × ✓ × ×

19 × ✓ × × ✓ ×

20 ✓ ✓ ✓ ✓ ✓ ×

21
21 × ✓ ✓ ✓ ✓ ×

22 ✓ ✓ ✓ ✓ ✓ ×

23 ✓ ✓ ✓ ✓ × ×

24 ✓ ✓ ✓ ✓ ✓ ×

25 ✓ ✓ ✓ ✓ × ×

26 ✓ × ✓ ✓ ✓ ×

27 ✓ ✓ ✓ ✓ × ×

28 ✓ ✓ ✓ × × ×

29 ✓ ✓ × ✓ ✓ ×

30 ✓ ✓ ✓ ✓ ✓ ×

4.3 Results of assay of Artovastatin using HPLC

4.3.1 Weight variation for Artovastatin

Table 3 : Weight Variation for Artovastatin

TABLET WEIGHT VARIATION IN DEVIATION FROM THE

MG MAIN WEIGHT IN MG

1 103.4 0.47

2 101.6 -1.33

3 104.1 1.17

4 102.5 -0.43

5 100.4 -2.53

6 102.5 -0.43

7 105.9 (MAX) 2.97

8 102.5 -0.43

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9 102.5 -0.43

10 102.4 -0.53

11 104.4 1.47

12 103.3 0.37

13 101.1 -1.83

14 103.3 0.37

15 104.8 1.87

16 102.3 -0.63

17 104.6 1.67

18 100.2(MIN) -2.73

19 104.7 1.77

20 102.1 -0.83

AVERAGE WEIGHT 102.93mg

Range {difference between maximum weight and minimum weight}=105.9-100.2mg which

is 5.7mg

Calculation on Average Mean Weight

Is done by adding all the weights of 20tablets measured and recorded and then dividing it by

the number of tablets which is 20 in this study.

Totol Artovastatin weights of 20tablets=2058.6mg

Number of tablets=20 in totol of Artovastatin

Then,Average Mean Weight=2058.6mg ÷ 20

102.93 MG

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

23
underscores the precision and reliability of the manufacturing process, contributing to the

overall quality of the medication.

4.4Assay of Artovastatin

Table 4 : Assay of Artovastatin

STANDARDS AND SAMPLES PEAK AREA CONCENTRATION

USED (MG/ML)

Standard 1 441354 0.01

Standard 2 299071 0.02

Standard 3 318815 0.04

Standard 4 785019 0.08

Sample A 614213 2.838

Sample B 427478 2.617

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 (0.08mg/ml, 0.04mg/ml

0.02mg/ml, 0.01mlg/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

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.
24
 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 0.5ml 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.

Generally,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

4.5 Discussion

The Pharmacy and Poison's Board strictly follow its rule that is to ensure that all

pharmaceutical drugs have to be regulated, which applies to those imported and also

produced within the country.The table shows that the country is in stability zone IV.The

Board also recommends that all drug products have to be kept at stable temperature of 30°C.

Table 5 : ICH climatic zones

25
 ICH and PPB labelling 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.2 : ICH climatic zones

Figure

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.

Figure 3:Figure showing parallel import of Norvasc 5mg

26
27
Figure 3 : Showing parallel import of Duphaston
Figure 4 : Showing parallel import of Cataflam

28
 900000
Column1
800000

700000

600000

500000
Column1
400000

300000

200000

100000

0
standard 2 standard 3 standard 4
Fig

ure 6 : Graph of assay of Artovastatin using HPLC

Y=mx+c

Y=44675x- 63989
Gradient =44675
Y intercept= -63989
Table 6 : Determination of the concentration of the samples.

Sample Concentration,mg/ml Concentration*10^-3

A 2.838 0.002838

B 2.617 0.002617

Average= 0.002682 + 0.002605

=0.005425÷2

=0.0026045mg/ml
Calculation of the dilution factor

29
 (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 ?

(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 b 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.

30
To maintain the dependability of pharmaceuticals and protect public health, the

pharmaceutical sector must implement strict quality control procedures.

CHAPTER FIVE: CONCLUSION AND RECOMMEDATION.

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%

5.2 Recommendations

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.

31
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.

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
32
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.

33
Figure 8 Chromatogram of the diluent

34
 REFERENCES

International Indigenous Biodiversity Forum in its opening statement at the Convention the

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)

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

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.

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)

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

Cas 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
Okinyi, J. (2019). Retrieved from https://www.capitalfm.co.ke/eblog/why-the government
must-curb-parallel-importation-of-Study of selected distributors in Kenya.
Nairobi, KE: United States International University, Unpublished MBA Thesis.
T Janke. Minding Culture: Case Studies on Intellectual Property Rights &

Traditional Cultural Expressions - The Carpets Case at http://www.wipo. int/tk/en/ (28

November 2009), pp. 71-72

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