India’s drug regulator has suspended approval for PresVu, an eye drop claiming to reduce dependence on reading glasses, citing unauthorised promotion and safety concerns. The company, Entod Pharmaceuticals, has challenged the decision, arguing their claims are based on US FDA approval and successful clinical trials.
Results for: DCGI
The Drugs Controller General of India (DCGI) is considering easing regulations for disinfectant manufacturers, potentially excluding them from the strict requirements for drugs. This move comes in response to the surge in demand for disinfectants post-COVID-19 and aims to streamline the licensing process. The DCGI is expected to issue a guidance note outlining specific requirements for obtaining licenses.