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The company said in a statement that the DCGI has approved the eye drop after a valid clinical trial was conducted on 234 patients which showed safety and efficacy of the eye drop. It said the patients of Presbyopia , who used the eye drop, were able to read lines on Snellenâs Chart.
Claiming its eye drop would reduce the use of glasses among people with Presbyopia, the Drug Controller General Of India (DCGI) has suspended the licence of eye drop company, PresVu, which was manufacturing and marketing its product in the country.
Presbyopia is a condition in which people find it difficult to focus on an object.
Sources in government said the stern action has been taken against the company after it came into notice that the eye drop maker is involved in unauthorised promotion and practice of its product. Sources further added that it was unsafe for people.
On the other hand, the company, Entod Pharmaceuticals, said that it will challenge the decision of DCGI in the court of law and denied any involvement in unethical practices and putting false facts before the authorities.
The company said in a statement that the DCGI has approved the eye drop after a valid clinical trial was conducted on 234 patients which showed safety and efficacy of the eye drop. It said the patients of Presbyopia , who used the eye drop, were able to read lines on Snellenâs Chart.
The company added that the US FDA has approved the eyedrop with similar ingredients and no serious complication has been reported in the country.
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