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Indian Pharmacopoeia Commission (IPC) decision for animal free testing of drugs

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The Indian Pharmacopoeia Commission has approved modern, animal-free tests for drug manufacturers, which is a major step that would spare animals from suffering due to drug experiments. The 2018 edition of Indian Pharmacopoeia, provides guidelines on tests for drugs manufactured and marketed in India.

What is Indian Pharmacopoeia Commission ?

Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India.

What are the new rules ?

With the Indian Pharmacopoeia Commission’s new rules, the pyrogen tests are replaced by a bacterial endotoxin test or a monocyte activation test which are performed in test tubes. The abnormal toxicity test carried out on guinea pigs and mice with tests that can be done in test tubes. Besides, vaccine and drug manufacturers are eligible to apply for waiver for the abnormal toxicity test. The waiver can be received getting a compliance certificate from the National Control Laboratory.

What are the types of Tests ?

Pyrogen Test: The Pyrogen Test is performed to check the presence or absence of pyrogens that can cause adverse side-effects. These tests are generally performed on rabbits as their body temperature increases when pyrogen is introduced by the parenteral route. It is termed as an obsolete test of the adequacy of the hypothalamic – adenohypophysis – adrenocortical axis, where regular timed doses of bacterial pyrogen induce an increase in plasma cortisol in average or normal subjects. Pryrogen testings are most used by top companies, since they define if bacterial toxins are present in vaccines and drugs that might cause fever when used on humans. It also determines if microbes or their metabolites are present in intravenous solutions during the manufacturing process. The most common type of pyrogen testing consists of injecting drugs into rabbits to determine if a fever develops or not. One of the oldest forms of Pyrogen test was based on the rabbits. This method was developed in the 1940s after some patients became ill from intravenous drugs.

Abnormal toxicity test: The test is also known as General Safety Tests. It is performed as a form of batch quality control and conducted to detect any potential hazardous biological contamination. This is mostly done prior to approval for direct administration in humans. Mice, guinea pigs and other small animals are used for conducting the test. These tests are considered vital since it is important for the detection of non-specific, extraneous toxic contaminants in antitoxins, antivenins, blood, blood derivatives, immune serums, immunologic diagnostic aids, toxoids, or vaccines.

What is the need for animal free testing ?

Currently, there are no laws protecting animals from physical, emotional pain and suffering once the testing. There is no medical requirement or compulsion to provide animals with pain-relieving drugs during these experiments, and animals who have not died by the end are usually killed. Many animal welfare experts claim that there are hundreds of thousands of animals were subjected to painful experiments. Besides, animals in laboratories endure not just the pain during the experiments but also face worst living conditions. Animals are often isolated for long periods of time; food and/or water may not be offered. Mothers and babies are separated. Almost all the animals are confined to small, barren cages having no resemblance whatsoever to their natural environment where loud noises and bright light are very stressful.

Despite the use of over several million animals in experiments globally each year, only 46 new medicines were approved in 2017 by the U.S. Food and Drug Administration. The US drug industry invests around USD 50 billion per year in research, but the approval rate of new drugs is the same as which is 40 to 50 years ago. There are evidences that only 6 per cent of 4,300 international companies involved in drug development have registered a new drug with the U.S. Food and Drug Administration. According to confirmed sources from US, over 1,000 potential stroke treatments that had been ‘successful’ in animal tests, only approximately 10 per cent progressed to human trials. But, none worked sufficiently well in humans. A review of 101 high impact basic science discoveries based on animal experiments found that only 5 per cent have resulted in approved treatments within 20 years.

Side effects of animals on testing

Despite the fact that animals do not get many of the human diseases have like, cancer, HIV, Parkinson’s disease, or schizophrenia. But there are numerous side effects. Here are some of them:

Skin sensitization: It is a major issue, when it comes to animal testing. It is an allergic response to a substance after skin contact. For example, the guinea pig test involves injecting a substance under the skin of guinea pigs trigger an allergic response. But such test causes their skin to become itchy, inflamed, ulcerated and painful. In some tests, a chemicals substance is smeared onto animals’ shaved skin, and the resulting irritation or skin damage which can include inflamed skin, bloody scabs, and ulcers—is observed.

Eye irritation and corrosion: Aiming to study irritation and corrosion, a substance is dropped or spread into the eyes of animals, mostly rabbits. Level of irritation or corrosions include swollen eyelids, irritated and cloudy eyes, and blindness. These conditions are clinically and subjectively assessed. But due the vast differences in ocular anatomy and physiology between humans and animals, many researchers say that exaggerates the eye irritancy response reported in humans. So these tests are invalid or not reliable.

Photo toxic method: It is a method where animals exposed to ultraviolet light after they are fed a test substance, or it is smeared onto their skin. Sometimes, the animals are exposed to sunlight in order to see whether they light induced skin irritation occurs. But once again, this cause wide and intolerable pain in the eyes of the animals.

Reproductive damage: To study reproductive abilities thousands of animals are forced to inhale or ingest a substance which are bred so that experimenters can observe any damage that it causes to reproductive organs and other issues. But these causes prolong damage to the reproductive system of the animals.

Cancer: In order to conduct research about carcinogenic effects on animals, many rodents and rats are forced to ingest or inhale these substances. Sometimes these subjects are injected into or spread onto their skin. The animals are exposed for at least two years before they are killed and examined for signs of cancer for tumor growth or abnormal cells. As a result, rats and other small animal suffer invariable pain.

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