ENTOD Pharmaceuticals to Contest DCGI Suspension of PresVu Eye Drops Licenses

ENTOD Pharmaceuticals plans to challenge the DCGI's suspension of manufacturing and marketing licenses for PresVu eye drops. The suspension was due to alleged unauthorized promotion and safety concerns. CEO Nikkhil K Masurkar denies any unethical conduct, citing adherence to approved indications and clinical data.

ENTOD Pharmaceuticals CEO Nikkhil K Masurkar announced that the company will challenge the Drugs Controller General of India's (DCGI) suspension of their manufacturing and marketing licenses for PresVu eye drops. This action follows the company's failure to address DCGI's queries regarding the product, for which no official approval was given.

Masurkar stated, "We have decided to challenge this suspension in the court of law to get justice. ENTOD Pharmaceuticals received the suspension order from the DCGI, who has made no reference to any specific violation of the Drugs and Cosmetics Act for this action." The Union Ministry of Health and Family Welfare had earlier noted the unauthorized promotion of PresVu, citing concerns over its safety and misuse as an over-the-counter drug despite being prescription-only.

The company denied any unethical or false presentation of facts related to PresVu eye drops. Masurkar reiterated the company's stance, asserting that all disclosed facts were based on approved indications and phase 3 clinical trial data. The company also stated that opinions and claims in news reports do not represent ENTOD Pharmaceuticals. However, sources from the drug regulatory body described the company's claims as unethical and misleading, necessitating an explanation from ENTOD.

(With inputs from agencies.)