Can a controversial toxicity test of drugs on the eyes or skin of animals be replaced, the Drug Controller General of India (DCGI) asked pharmaceutical companies and laboratories on Wednesday.
In a Draize test, a researcher applies testing drugs on animals.
To deal with this sensitive issue, the regulator had formed a committee that met on May 23 for the first time. The committee said as there was an international movement to replace tests on animals with alternatives, it should be considered here also. A decision would be taken only after obtaining assessment of feasibility, validation and preparedness of Indian laboratories.
The procedure generally involves applying 0.5 millilitre or 0.5g of a test substance to the eye or skin of a restrained, conscious animal. After a stipulated period, the effects of the drug are recorded.
The animals (generally rabbits) are observed for up to 14 days for signs of erythema or edema in skin tests, and redness, swelling, discharge, ulceration, haemorrhaging, cloudiness, or blindness in eye tests. If the test renders irreversible damage to the eye or skin, the animals are euthanised.
One of the main contentions of the committee was if pre-clinical testing labs in India were equipped for such a change. "Have the alternative methods been validated, particularly in India? Do we have adequate number of laboratories to undertake toxicity testing of all required substances by alternative methods?" the committee asked.
The drug regulator has given two weeks to laboratories carrying out such tests - from the public sector, private sector and related organisation from the pharmaceutical industry - to send their responses.
