dryeye3
A new treatment for dry eye: A viewpoint
1. Introduction
Before any medicine can be sold in Australia, it must first be listed on the Australian Register of Therapeutic Goods (ARTG).
There are 2 types of entry in the ARTG:
Some medicines are "registered" and have an AUST R number. Some medicines are "listed" and have an AUST L number. The Therapeutic Goods Administration (TGA) decides whether or not a medicine has an AUST R or an AUST L number. AUST R medicines include such things as prescription medicines and over - the - counter medicines such as aspirin and paracetamol tablets. AUST L medicines include such things as herbal remedies, most vitamin or mineral supplements and traditional Chinese medicines.
For example, Coles antiseptic, active ingredient chloroxylenol, 48 mg / g, has a number, AUST R 28611.
It is not known whether the TGA will regard an eye drop for dry eye syndrome as an AUST R or an AUST L medicine.
Before a new medicine can be "registered," that is before it can obtain an AUST R number, it must have:
extensive information about the synthesis of the medicine,
the method of manufacture of the dose forms,
studies of its pharmacology and toxicology in animals and clinical trials in humans, demonstrating the efficacy and safety of the medicine , in its proposed use.
The manufacture of medicines in Australia must comply with Good Manufacturing Practice.
Sponsors of AUST L medicines must hold evidence to substantiate their claim.
2. Therapeutic Goods Act 1989 ( the Act )
Before any medicine can be sold in Australia, it must also comply with the Therapeutic Goods Act 1989 (the Act)
According to the Act, a medicine is defined as goods that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be for medical use, or for use as an ingredient or component in the manufacture of the medicine.
This means that as soon as anyone claims that any substance has healing powers, no matter what that substance may be, then that substance automatically becomes a medicine and falls within the jurisdiction of the Act.
Under the Act, it is unlawful for anyone to :
sell a medicine, advertise a medicine for sale, export a medicine and give away free samples of a medicine unless approved by the Therapeutic Goods Administration ( TGA).
The penalty for a breach of the Act is a $50,000 fine and 6 months imprisonment.
The same penalty applies whether a person sells a real medicine or a fake medicine, without the approval of the TGA.
For a medicine to be approved by the TGA it must have:
extensive information about the synthesis of the medicine,
the method of manufacture of the dose forms,
studies of its pharmacology and toxicology in animals and
clinical trials in humans demonstrating the efficacy and safety of the medicine.
Clinical trials occur in three phases:
In the first phase, say, 10 healthy volunteers test the medicine for any harmful effects.
In the second phase, say , 100 healthy volunteers test the medicine for any harmful effects and also test if the medicine can do what it claims that it can do.
In the third phase, say, 1,000 healthy volunteers test the medicine for any harmful effects and also test if the medicine can do what it claims that it can do.
Passing all of the clinical trials does not necessarily mean that the TGA will approve the medicine.
All of the volunteers taking part in the clinical trials would need to be paid, as would all of those supervising the clinical trials. In the case of eye drops for dry eye syndrome, those involved in the supervision of the clinical trials would be ophthalmologists and ophthalmologists do not come cheap. A volunteer involved in a clinical trial of any medicine would expect to be paid approximately $1,000 and considering that we have approximately 1,000 volunteers involved in the clinical trials, then this figure would come to approximately 1 million dollars, just for the cost of the volunteers alone. At these costs, it is surprising to find that anyone, not even the large medical research organisations, would be prepared to become involved in medical research. The cost of medical research throughout the world, at the present time has become entirely prohibitive.
3. Availability of my eye drops
Unfortunately, my eye drops are currently unavailable for sale or distribution anywhere in the world because of the huge costs involved in bringing them onto the market and looking at all of these costs , it will be a long, long time before they ever do become available.
The world will never know whether or not my eye drops were a truly wonderful, amazing advancement in the treatment of dry eye syndrome, or merely just another whimsical pipe dream.
All that I do know is that they are working for me.
Written by
The Eye Enigma
25 August 2020
https://sites.google.com/view/haigis
https://sites.google.com/view/dryeye2