Part 5: Medicine, its
birth and death ☠
Preamble
It was an evening. I was on examination duty in a small town. The food
served at the Inspection bungalow was very hot and I could not cope with it. I visited the only bakery available.
The bakery owner stood in front of the Almighty praying. I asked for a loaf of
bread. He queried inquisitively, “Sir, I hope ALL IS WELL.” I was surprised.
Jokingly, he told me that he prays God to make people ill in this town.
He started narrating his experience. People here purchase bread only
when they are ill. They believe the medicine and the bread are the two sides of
the same coin. If there is no sale of bread, it’s an inference that ALL IS WELL
in the town. Meanwhile, an old person came for the bread. He was carrying
tablets in his hand. After purchasing the bread, he asked the bakery owner, “Is
this medicine OK for fever Swamy? He was when
told, that it is Paracetamol taken to bring down the fever.
After a few complimentary chats, the bakery owner and I, realized, that
we were schoolmates, once upon a time. After realising that I am a Chemistry
Professor, he was curious to know, how these medicines are made. I gave him a
“Bird's eye view” of the pathway.
“Necessity is the mother of invention,” I started.
The System
All living things have a working body to sustain. Each part is
synchronised. The neuro system links these parts. A God’s own web design. As
long as the parts are working, we feel normal. The moment a part malfunctions,
the feeling of abnormality creeps in. We do not feel at ease. This could be an
internal or an external problem. We tend to set things right on our own or
discuss them with others. The clever God has also provided us a built-in immune
system.
When malfunctions become common, affecting a large number of people, it
raises an alarm. People set out to find remedies. Explorations start. Any
material which could rectify this problem was accepted. Locally available
herbs, household materials, soil, earth, fire, water, and so on were used.
Hakeem’s, Vaidya’s came into existence. On many occasions, the grandma’s became
the darling healers. The church priests too developed the art of healing. A few
attributed it to the evil effects of devils and demons. The term medicines came
into existence. On the basis of the origin, medicines were labelled as
Allopathic, Ayurvedic, Homeopathic, and Unani and so on. The more the varieties of
illness experienced, the greater were the medicines discovered. Though the term
“Drugs” is also used, let us for obvious reasons, stick to the term Medicines.
In each school of approach, we find a common factor.
Based on the preparations, medicines can be classified
as topical and systemic. Topical preparations are that applied on the body
surfaces e.g. creams, jells, ointments, lotions, eye drops etc. Systemic
preparations are given via systemic routes like oral or intravenous e.g.
(tablets, capsules, syrups are oral, injection are mainly intravenous). These are the only representative.
The field is oceanic.
Why and how are medicines born?
As envisaged earlier, whenever an abnormal symptom is observed and also
seems to be spreading, the concerned authorities get alerted and speak to the
Health experts. A data is collected after observing the ill-affected. Urine and
blood samples are collected. Microbiologists and pathologists analyse the
samples and prepare a chart of observations. The advent of a microscope has
come as a boon. The root cause of the abnormality is tentatively guessed. For
example, it could be a viral infection. If needed, further advanced studies
available from time to time is done. Once confirmed, it is referred to the
various agencies to exploit a method of managing the cause. The agencies could
be Research and Development organization, National laboratories, Recognised
institutes or even Universities. There are agencies to fund research projects
also. They set out on a definite model/plan of the probe to attack the problem. A
few general approaches are:
1. Completely eliminate the intruder
causing abnormality or drive him out.
2. Cage it and make it defunct.
3. Convert it into an inactive form.
4. Others as the case may be.(Burning
through radiology method or laser treatment)
Let us not get into the technicalities. The experts call it “Drug Design and modelling”.
Once they find a sample, it is subjected to biological activity studies on identified systems. If the sample is found active, it is tested on specific animals. After this stage is over, permissions are obtained from the National authorities including those concerned with Drugs management to conduct a test on volunteers. Here in addition to the effectiveness of the sample, side effects are also ascertained from the volunteers if any. In all these stages, the role of Pharmacologist’s and physician investigators is prominent. These preliminary stages themselves will take away a few years. Based on the reports and feedback, modifications are done if need be. The ethnicity factor is also covered. One in thousands of sample gets selected.
Mock production
Once the sample is
approved, it is subjected to mock production. As these samples are prepared in
a laboratory scale to the extent of grams. The Chemical engineers take over to
design and model production plants. The productions could be in the scale of
tons. Even here, samples undergo competition. The cost of royalty, production,
packing and distribution is compared.
Patent and Royalty
In the meanwhile, the
agency/person who is bringing this medicine out to the market applies for a
patent to the appropriate agency. Once the patent is registered, Drug
manufacturing agencies/companies bid for the mass production and sale of this
approved medicine. The company pays Royalty to the person who brought out this
medicine and/or the institute for a certain period of time. Once it is done,
the company is granted a license for the manufacture, distribution and monitoring
by the Drug controllers of the country.
Labelling Specifications
The Drug monitoring
agencies of each country specify certain norms regarding the medicines. Each
container should necessarily have a label, displaying the inner contents of the
medicines called specifications with percentages, warnings etc.… This has to be
rigidly followed. Significant is the manufacturing date and the expiry date.
Distributing agencies
(Logistics)
Through the licensed
distributors, the logistics is finalised. The medical representatives play a
key role in this, as they visit doctors to explain the efficacy of this
medicine and impress upon them to prescribe. They also visit the Pharmacy
outlets to make available these medicines.
Shelf life
Shelf
life means, how long the medicine can stay, that means, the period between
manufacturing date and expiry date. The manufacturing companies and the
pharmacy or the medicine stores have also to worry about the shelf life of the
medicine. It also depends upon the demand and supply ratio. All medicines have
a shelf life/expiry date. Sometimes, a particular medicine may be altogether
banned abruptly.
We do not realise the
intricacies involved in the making of the medicines and the cost of its
production. We hold the tablet in our hand, throw it into our mouth, just
swallow it drinking water. It takes brain, time, efforts and money. A gigantic
task indeed. Years of effort, crores of money, enormous hurdles are involved to
keep all of us HEALTHY AND HALE.
The Death
The medicine, once its
role is over, is dead. It leaves our system unceremoniously. So after the
expiry date. Hail your medicine.
Medicine, its birth
and death ☠ to be
continued in part 6.
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