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The Indian Pharmacopoeia Commission has approved modern, animal-free tests for drug manufacturers.
FACTS FOR PRELIMS
In the 2018 edition of Indian Pharmacopoeia, that provides guidelines on tests for drugs manufactured and marketed in India, the IPC 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 pyrogen test will be replaced by a bacterial endotoxin test or a monocyte activation test which can be carried out in test tubes. Vaccine manufacturers can apply for a waiver for the abnormal toxicity test by getting a compliance certificate from the National Control Laboratory instead.
The pyrogen test is carried out to check impurity or substance that can cause adverse side-effects. For the test, the drug is injected into a rabbit and the animal is closely observed for feverish symptoms.
Abnormal toxicity test
The abnormal toxicity test is carried out to check potential hazardous biological contamination in vaccine formulations.
This batch test is done before the product is approved for marketing. In this, mice or guinea pigs are injected with the vaccine. The scientists observe if there is the death of any animal.
Indian Pharmacopoeia Commission
Indian Pharmacopoeia Commission (IPC) is an Autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India. IPC is created to set standards for drugs in the country. Its basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region.