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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5855_Библиотеки_им_академика_М_И_Перельмана.pdf
Chapter 1
Evolution of Pharmaceutical
Inspection in Singapore and
Benchmarking to PIC/S
3
1.1. Singapore as a British Colony
et us begin this chapter on the evolution of the pharmaceutical inspection and licensing system in Singapore by
taking a trip down memory lane to the 1930s and 1950s.
L
state was very dierent from what it is today. Appended on pp. 4–5
are four photographs showing how Singapore has changed since its
founding by Sir Stamford Raes (from Britain) in 1819. Today, a
marble statue of Stamford Raes stands at the historic site where
he landed. There is also a plaque beneath the statue stating how
Singapore has been transformed “from an obscure fishing village
to a great seaport and modern metropolis”. Presently, Raes Place
Then, Singapore was still a British colony, and the city
4
Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Statue of Stamford Raes — located at historic site where he landed in 1819
and Orchard Road are two of the foremost commercial centers and
shopping belt of Singapore. The 1930s and 1950s are chosen as the
starting points to begin this evolution journey because they were
the periods when the first sets of pharmaceutical laws were published in Singapore by the British colonial government.
Plaque beneath statue of Stamford Raes
Evolution of Pharmaceutical Inspection in Singapore and Benchmarking to PIC/S
5
Orchard Road, present day
Raes Place, present day
6
Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
1.2. Implementation of the Poisons Act, Poisons Rules
and Other Pharmaceutical Laws
The Poisons Act was first published in 1939 whilst the Poisons Rules
were published in 1957. The Poisons Act was originally called the
Poisons Ordinance Chapter 146 when it was first published at that
time while Singapore was still a British colony. A copy of the cover
page of the Poisons Ordinance Chapter 146 and the Poisons Rules
1957 are shown below.
The Poisons Act (Poisons Ordinance) — published in 1939
Evolution of Pharmaceutical Inspection in Singapore and Benchmarking to PIC/S
7
The Poisons Rules — published in 1957
Back then, the British colonial government in Singapore had a Legislative Council comprising the Governor, Chief Justice, AttorneyGeneral and a team of ocials and unocial Europeans. This
Legislative Council, established in 1867 by the British colonial
government, approved all legislation in the Straits Settlement, comprising Singapore, Malacca and Penang. Today, Singapore is a sovereign nation with its own Parliament and President as Legislature.
Presented next are photograph montages showing how the
Singapore healthcare and pharmaceutical sectors from the 1930s
8
Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Evolution of Pharmaceutical Inspection in Singapore and Benchmarking to PIC/S
to 1950s look like. Back then, the largest and oldest hospital in
Singapore, namely the Singapore General Hospital, was already
established. It was built in 1821 as the Outram Road General Hospital. Tan Tock Seng Hospital, the 2nd oldest hospital in Singapore, was
established soon after, in 1844. The present-day Alexandra Hospital
was built as a British military hospital in 1940. There were only a few
drug stores and pharmacies around, and they were mainly involved
in compounding simple preparations like tinctures and mixtures.
Batch-scale pharmaceutical manufacturing was limited to companies such as Haw Par Healthcare and Leung Kai Fook Pte Ltd which
made quasi-medicinal products like Tiger Balm and Axe Brand Medicated Oil, respectively. Local pharmaceutical manufacturers such
as Beacons Pharmaceuticals and Sunward Pharmaceutical, and multinational corporation (MNC) pharmaceutical manufacturers such
as Glaxo, Pfizer and Roche had not set foot in Singapore yet.
9
Singapore pharmaceutical & healthcare sector from 1930s to 1950s
10
Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Moreover, in the 1930s to 1950s, other industrial businesses such as
the manufacture of rubber and textile products, canned fruits and
food products, were highly manual and cottage-like.
Singapore industrial/business sector — 1930s to 1950s
Household products, which were made locally in the colony of
Singapore, included canned food, rubber bags, T-shirts and singlets,
soaps, detergents and antiseptics. Many of these locally made products required the use of industrial chemicals such as sulfuric acid
and sodium hydroxide (caustic soda) for their manufacturing. The
Poisons Act controlled Part I Poisons, which were pharmaceutical
Poisons used in hospitals and other healthcare institutions. The Poisons Act also controlled Part II Poisons such as sulfuric acid, sodium
hydroxide, benzene and organo-phosphorus; these were chemical
Poisons used in the manufacturing industry. Special permits were
Evolution of Pharmaceutical Inspection in Singapore and Benchmarking to PIC/S
required for the handling of Part II Poisons as they had the potential
of being misused or abused, including by gangsters and criminals
to attack one another during fights, or even by mentally depressed
folks to commit suicide. In many ways, the Poisons Act and the
Poisons Rules served the purposes of restricting the sale, supply and
use of Part I and Part II Poisons for legitimate use in healthcare and
industrial manufacturing, whilst at the same time preventing their
misuse, abuse or illegitimate use.
In 1999, the Poisons Act was revised to transfer the control of Part
II Poisons to a new legislation called the Environmental Protection
and Management Act. The National Environment Agency under
the Ministry of Environment and Water Resources took responsibility for the management and legislative control of Part II Poisons, which were re-categorized as Hazardous Substances. The Health
Sciences Authority (HSA), and its predecessor organization, namely
the National Pharmaceutical Administration under the Ministry
of Health, retained the legislative control of Part I Poisons, which
are now referred to simply as Poisons. Today, the Schedule to the
Poisons Act, also called the Poisons List, comprises only Poisons for
pharmaceutical use.
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In summary, the Poisons Act, the Poisons Rules, and the associated
Poisons List had provided the fundamental basis for legislative control of Poisons during the greater part of the 20th century. This legislative control was implemented via a system of authorized users
and buyers, proper mandatory record-keeping, as well as the use of
cautionary labels to warn users of the potency, toxicity and potential dangers of Poisons. The concept of sa fety, ecacy and quality
for medicinal products, and Good Practices such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good