History of Pharmaceutical industry in Nigeria

Question 1

According to Lagos Business School, the Nigerian pharmaceutical industry is
currently estimated to be

Answer 1

$1.5 billion in value in terms of generics (branded and
unbranded)

Question 2

The Nigerian pharmaceutical industry contributes less than 1% to Nigeria’s Gross Domestic
Product (GDP). True or false.

Answer 2

False. It contributes less than 0.5% to Nigeria’s Gross Domestic
Product (GDP)

Question 3

What was the growth rate in 2013 compared to 2018

Answer 3

Its growth rate has slid from 8% in 2013 to below 3% in 2018
despite aggregate 20% price increase

Question 4

In
2009, the Pharmaceutical Manufacturing Group of the Manufacturers’ Association
of Nigeria (PMGMAN) estimated the size of the total pharmaceuticals and
healthcare products market to be?

Answer 4

in excess of US$ 2 billion annually.

Question 5

What is PMGMAN

Answer 5

Pharmaceutical Manufacturing Group of the Manufacturers’ Association
of Nigeria

Question 6

According to PMGMAN, The estimated
market for prescription ethical pharmaceuticals is?

Answer 6

US$ 500 million

Question 7

According to PMGMAN, The estimated
market for over
the counter (OTC) pharmaceuticals is?

Answer 7

about US$ 900 million.

Question 8

PMG-MAN estimates the Nigerian market for biological products (including
vaccines, insulin, interferon, etc.) to be worth

Answer 8

about US$ 100 million.

Question 9

PMG-MAN estimates the related healthcare and lifestyle products account for

Answer 9

about US$ 500 million.

Question 10

Glaxo and Pfizer were established in

Answer 10

1950.

Question 11

The first pharmaceutical industry to be established in Nigeria was a
multinational called

Answer 11

May and
Baker was established in 1944 and engaged majorly in importation
and marketing of pharmaceuticals.

Question 12

May and Baker originated from?

Answer 12

England, the United Kingdom where in 1834, three
chemists Grimwade, May and Pickett, founded a firm for
manufacturing chemicals for pharmaceutical products.

Question 13

there was no actual pharmaceutical
manufacturing industry that was established in Nigeria between the years:

Answer 13

1900-1950

Question 14

Between 1950 to 1980 some pharmaceutical companies that were
established these include

Answer 14

Evans Medical

Neimeth International Pharmaceuticals

Nigerian-German Chemicals

SKG Pharma

Afrab Chem Limited

Gemini Pharmaceuticals Nigeria

Swiss Pharma Nigeria Ltd: Nigeria

Mopson Pharmaceutical Industries

Question 15

Between 1980 to 2000 pharmaceutical companies that were
established these include

Answer 15

Emzor Pharmaceuticals

Fidson Healthcare Plc

Archy Pharmaceuticals Limited

Question 16

There are five main units of a pharmaceutical industry which are:

Answer 16

Research and Drug development

Production

Quality control

Quality assurance

Storage and Distribution

Question 17

The aim of pharmaceutical
development is?

Answer 17

to design a quality product and its manufacturing
process to consistently deliver the intended performance of the
product.

Question 18

The information and knowledge gained from pharmaceutical
development studies provides

Answer 18

clear scientific understanding to support
the establishment of specifications and manufacturing controls which
will thereafter enable to ensure a pharmaceutical product’s quality
throughout its life cycle.

Question 19

Production covers all operations involved in the preparation of a pharmaceutical product, including

Answer 19

receipt of materials, through processing, packaging, labelling, to completion of the
finished product.

Question 20

What is GMP?

Answer 20

Good manufacturing practice (GMP) is that part of a quality management system
to ensure that products are consistently produced and controlled to the quality standards
appropriate to their intended use and as required by the marketing authorization.

Question 21

GMP is
aimed primarily at diminishing the risks inherent in any pharmaceutical production; which
may broadly be categorized into two groups:

Answer 21

(1) cross-contamination/mix-ups
and (2) false labelling.

Question 22

The term “quality control” refers to

Answer 22

The term “quality control” refers to the sum of all procedures
undertaken to ensure the identity and purity of a particular
pharmaceutical.

Question 23

Quality control procedures may range from:

Answer 23

Such procedures may range from the performance of
simple chemical experiments which determine the identity and
screening for the presence of particular pharmaceutical substances
(e.g. thin layer chromatography, infrared spectroscopy, and so on), to
more complicated requirements of pharmacopoeial monographs.

Question 24

Quality Assurance involves

Answer 24

Quality Assurance involves ensuring that the products or services in
the pharmaceutical industry meet the required quality standards. Its
purpose is to establish and uphold customer confidence in the
product by identifying and preventing defects at an early stage.

Question 25

Any comprehensive system of quality assurance must be founded on

Answer 25

Any comprehensive system of quality assurance must be founded on a reliable system of controlling the quality, safety and efficacy of a finished product delivered to a market.

Question 26

Why are Storage and distribution important activities in the supply chain management of medical products?

Answer 26

Various people and entities may be responsible for the handling, storage and distribution of medical products. Medical products may be subjected to various risks at different stages in the supply chain, for example, purchasing, storage, packaging, labelling, transportation and distribution.

Question 27

For the compression of granules in the form of tablets, various types of machines are used such as

Answer 27

Single punch machines High-speed rotary tablet machines Multilayer rotary tablet machines

Question 28

What are single punch tabletting machines used to prepare?

Answer 28

For small-scale production, a single punch tablet machine is used to prepare small quantity of tablets.

Question 29

The output of tablets from a single punch machine is

Answer 29

about 200 tablets per minute.

Question 30

Explain the process of compression in tabletting

Answer 30

The formulated powders or granules are fed (usually by gravitational flow) into the die section, i.e. in the space between the lower and upper punches, from the hopper on the tablet press. The volume of space occupied by the granules/ powders is defined by the position of the lower punch and the die plate (also where the feed shoe of the hopper resides). Accordingly, the mass of solid material within this space (and hence the size of the tablet) is altered by increasing/decreasing the position of the lower punch. The upper and lower punch come together to compress the powder within the die cavity and the tablet is ejected.

Question 31

Some faults in the formulation or in the tabletting equipment. These defects are

Answer 31

Picking and sticking Capping and Lamination of tablets Mottling Chipping Double Impression

Question 32

What's the difference between Picking and sticking?

Answer 32

In picking, a small surface of the tablet material is removed by the punches and adheres to the surface of punches and tablets show a pitted surface due to presence scratches on the punches or wet granules while In sticking, the granules adhere to the die wall and thereby lower punch can not move freely.

Question 33

Remedies for Picking and sticking include

Answer 33

Re-drying of granules The worn-out dies and punches must be replaced Changing the type of binder and using a less adhesive type binder Addition of lubricant in the granules

Question 34

What is the difference between Capping and Lamination of tablets

Answer 34

In capping, the upper and lower surface of the tablet partially or completely separates out from the main body of the tablet. In lamination, the tablet separates in two or more layers

Question 35

How can capping and Lamination of tablets be corrected

Answer 35

Correction may be carried out by regranulating the material, altering the pressure adjustments or reducing the speed of the tableting machine.

Question 36

What are the causes of capping

Answer 36

Overdrying of the granules The presence of either excess of fine powder in granule or less amount of fine powder in granules. The wear and tear of punches may also be responsible for capping The wrong setting of dies and punches The use of too soft granules also lead to capping

Question 37

How can capping be remedied

Answer 37

Water should be added in the form of spray in the granules Proper granules and required amount of powder must be used. The wear and tear punch must be replaced. The proper setting of dies and punches.

Question 38

what are the causes of lamination

Answer 38

Entrapped air in the granules Excess powder on the granules Insufficient binder in the formulation.

Question 39

how can lamination be prevented

Answer 39

Altering the Pressure adjustment Required amount of powders must be maintained Increasing the percentage of the binders Changing the types of binders in the formulation.

Question 40

What is mottling and how can it be solved?

Answer 40

This defect occurs in the colored tablets and this defect may be caused either due to the difference of colors in the drugs and excipients or Due to the migration of dyes during drying of granules. Defect is solved by changing the solvent system or by drying the granules at a low temperature.

Question 41

What are the causes and remedies of chipping

Answer 41

Causes: Chipping, or the breakage of small bits of tablet edges, can occur when there are substandard die shapes or conditions. Wet material, insufficient lubricant, and improper binders that lead to sticking. Due to the improper setting of feed frame. The feed frame is a force-feeding device used in the die filling process. The die filling process is crucial within pharmaceutical manufacturing to guarantee the critical quality attributes of the tablets. Remedies: Proper setting of the feed frame.

Question 42

What is double impression?

Answer 42

A dark and a lighter impression on tablet surface is called double impression. It is the problem due to mechanical hazards specially with punches.

Question 43

What causes double impression and how can it be solved?

Answer 43

Uncontrolled free rotation of the lower punch during ejection of the compressed tablets. Remedy: Fit an anti turning device with lower punch, which prevents the rotation of the lower punch.

Question 44

Advantages of instrumented tablet presses include

Answer 44

Ability to independently control weight, thickness and hardness of tablets, if equipped with available peripheral devices The capability to produce up to 1,000,000+ tablets per hour, depending on press size and tooling configurations. Ability to precisely control and manage the filling of die cavities, through an induced feeder Greater cost efficiency than single punch presses

Question 45

What are the uses of tablet presses?

Answer 45

1. Rotary presses can essentially meet most tablet batch requirements in pharmaceutical, nutraceutical, confectionery and veterinary applications. 2. They are also used with surprising frequency to produce catalysts, ceramics, powdered metals and other materials deemed suitably compressible.

Question 46

What was the Effect of COVID on the pharmaceutical sector

Answer 46

Coupled with the reduced importation capacity which signifies impending drug scarcity, the surge in the need for medications during this period intensified the pressure on the available stock of medicines locally. This led to price hikes and scarcity. COVID-19 presented a unique opportunity which led to increased production of drugs locally hence strengthening the pharmaceutical sector.

Question 47

The big questions amidst the COVID pandemic were

Answer 47

(1) Will the local pharmaceutical industry in Nigeria be able to cater for the medicine needs? (2) Will the international travel ban obstruct the availability of essential medicines in Nigeria?