CDSCO Suspends ETOD Pharmaceuticals' Eye Drops for Presbyopia Treatment

CDSCO Takes Action Against ETOD Pharmaceuticals

NEW DELHI: India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has suspended both the manufacturing and marketing permissions of Mumbai-based ETOD Pharmaceuticals. This suspension follows the company's claims that their eye drop, PresVu, could significantly reduce the dependency on reading glasses for individuals suffering from presbyopia, an age-related vision condition.

Concerns Over Promotion and Safety

The CDSCO had previously approved PresVu for market release. However, recent unauthorized promotions have raised serious safety concerns, leading to the suspension until further notice. Dr. Rajeev Singh Raghuvanshi, the Drug Controller General of India (DCGI), requested an explanation from ETOD Pharmaceuticals, highlighting serious doubts regarding the eye drop’s safety due to misleading marketing practices.

Company's Response and Legal Action

In light of the suspension, ETOD Pharmaceuticals’ CEO, Nikkhil K Masurkar, firmly denied any unethical practices and stated their intention to challenge the suspension legally. He argues that the company has only presented factual information based on their recent regulatory approval and clinical trial results.

Public Health Implications

• The unauthorized promotion raised significant public health risks.
• Concerns about short and long-term side effects of using eye drops have been raised by medical experts.
• The CDSCO's notice emphasizes that claims made by the company were not backed by necessary approvals.