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Indian Pharmacopoeia Commission approves modern animal-free testing for drugs

Indian Pharmacopoeia Commission approves modern animal-free testing for drugs

In a step that would spare animals from suffering due to drug experiments, the Indian Pharmacopoeia Commission has approved modern, animal-free tests for drug manufacturers. It was declared during the 2018 edition of Indian Pharmacopoeia that provides guidelines on tests for drugs manufactured and marketed in India. (IPC) is an Autonomous Institution of the Ministry of Health and Family Welfare, Government of India.

New Guidelines

  • The Commission has replaced the pyrogen test carried out on rabbits and the abnormal toxicity test carried out on guinea pigs and mice, with tests that can be done in test tubes.
  • The mandate has been listed in the eighth edition of the ‘Indian Pharmacopoeia’ and it will come into effect from July 1.
  • Animal testing helps the researchers to study numerous diseases. During the testing, animals are artificially induced with diseases and conduct experiments.
  • Various diseases are artificially produced in laboratories in an attempt to mimic the human disease; this allows researchers to develop a new drug by testing on animals and to obtain cues on how the disease develops in the human body.

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.
  • Abnormal toxicity test: The abnormal toxicity test is a form of batch quality control and conducted to detect any potential hazardous biological contamination prior to approval for direct administration in humans. The test is conducted on mice or guinea pigs. This test is done before the product is approved for marketing.

Government Regulations

  • Drugs and Cosmetics Act, 1940: This Act regulates the manufacture, distribution, imports of cosmetics and drugs in India. Its aim is to ensure that the drugs and cosmetics sold in the country are safe, effective, and meet standards of quality as established by the Act.
  • Committee for the Purpose of Supervision of Experiments on Animals (CPCSEA): The body is responsible for ensuring that the animals are not subjected to unnecessary pain or suffering before, during or after the experiments performed on them.

 

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