Pharmaceutical Industry

Question 1

Discuss the present state of the pharmaceutical industry in Nigeria.

Answer 1

• According to Lagos Business School, the Nigerian pharmaceutical industry iscurrently estimated to be $1.5 billion in value in terms of generics (branded and unbranded).
• The industry contributes < 0.5% to Nigeria’s GDP and its growth rate has dropped from 8% in 2013 to below 3% in 2018 despite an aggregate 20% price increase.
• In 2009, the Pharmaceutical Manufacturing Group of the Manufacturers’ Association of Nigeria (PMG-MAN) estimated the total size of the pharmaceuticals and healthcare products market to be in excess of US$ 2 billion annually.
• The estimated market for prescription ethical pharmaceuticals is US$ 500 million and for (OTC) pharmaceuticals, about US$ 900 million.
• Furthermore, PMG-MAN estimates the Nigerian market for biological products to be worth about US$ 100 million., and related healthcare and lifestyle products account for about US$ 500 million.

Question 2

Discuss the establishment of the first pharmaceutical industry in Nigeria.

Answer 2

The first pharmaceutical industry to be established in Nigeria was May and Baker, a multinational in 1944.

It engaged majorly in importation and marketing of pharmaceuticals.

It was founded in England in 1834 by three chemists, Grimwade, May, and Pickett, for manufacturing chemicals for pharmaceutical products.

Question 3

When were Glaxo and Pfizer established in Nigeria

Answer 3

1950.

Question 4

Comment on the establishment of pharmaceutical industries in Nigeria between 1900-1950.

Answer 4

Between the period 1900-1950 there was no actual pharmaceutical manufacturing industry that was established in Nigeria.
Most pharmaceutical companies were subsidiaries of existing Multinationals.

Question 5

Mention 5 pharmaceutical companies that were established between 1950-1980

Answer 5

1. Evans Medical
2. Neimeth International Pharmaceuticals
3. Nigerian-German Chemicals
4. SKG Pharma
5. Afrab Chem Limited
6. Gemini Pharmaceuticals Nigeria
7. Swiss Pharma Limited
8. Mopson Pharmaceuticals Industries

Question 6

Mention 3 pharmaceutical companies that were established between 1980-2000.

Answer 6

1. Emzor Pharmaceuticals
2. Fidson Healthcare PLC
3. Archy Pharmaceuticals Limited

Question 7

Answer True or False

• The industrial pharmacy was the first among all other areas of pharmacy practice to give prestige to the pharmacy profession.
• This was achieved through the way the multinational companies marketed their drugs and took care of their staff.
• The trend which started in the early 1960’s and continued to the early 1980’s saw the attraction of many young pharmacists to the profession.
• The ancillary industry is not a vital part of the pharmaceutical supply chain.

Answer 7

• True
• True
• True
• False. It is vital to the supply chain.

Question 8

Discuss the five main units of a pharmaceutical industry.

Answer 8

1. Research and Drug Development: The R&D unit is responsible for discovering, developing, and testing new drugs and therapies. The information and knowledge gained from pharmaceutical development studies provides 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.
2. Production: Production covers all operations involved in the preparation of a pharmaceutical product, from acquisition of materials, through processing, packaging, labelling, to completion of the finished product.
   It involves converting active pharmaceutical ingredients (APIs) into final dosage forms (e.g., tablets, capsules, injectables), while adhering to Good Manufacturing Practices to ensure product quality and safety.
3. Quality Control: Quality control refers to the sum of all procedures undertaken to ensure the identity, quality and purity of a particular pharmaceutical. These procedures may range from simple chemical experiments to determine the identity and screen for the presence of particular pharmaceutical substances (e.g. thin layer chromatography, infrared spectroscopy, and so on), to more complicated requirements of pharmacopoeial monographs.
4. Quality Assurance: This unit ensures that all products, processes and systems comply with regulatory and quality standards. standards. Its purpose is to establish and uphold customer confidence in the product by identifying and preventing defects at an early stage.
5. Storage and Distribution: This unit ensures the safe and efficient storage and delivery of pharmaceutical products to end-users.
   It involves activities, such as storing products under controlled conditions to maintain stability, inventory Management, distribution Logistics, and in the case of biologics, cold-chain management.

Question 9

The risks associated with production are largely categorised into:

Answer 9

1. Cross-contamination/mix-ups
2. False labelling

Question 9

What is GMP?

Answer 9

GMP (Good Manufacturing Practice) is a set of guidelines and standards that ensure the consistent production and control of products according to quality standards appropriate for their intended use and as required by regulatory authorities.

Question 10

Mention 3 types of machines used in tablet compression.

Answer 10

i. Single punch machines
ii. High-speed rotary tablet machines
iii. Multilayer rotary tablet machines

Question 11

What is the output of single punch machines?

Answer 11

200 tablets per minute