Why permission for eye drop to replace spectacles was revoked
The Drugs Controller General of India (DCGI) has suspended the approval previously granted to Entod Pharmaceuticals, for the production and sale of its new eye drop. The drop claimed to reduce dependency on reading glasses for those suffering from presbyopia. The suspension order is based on the company's alleged failure to secure approval from the Central Licensing Authority, for its product claims. The DCGI has accused Entod of violating manufacturing permissions under the New Drugs and Clinical Trial Rules, 2019.
Entod's response to suspension order
Entod Pharmaceuticals has refuted any allegations of unethical representation. The company's CEO, Nikkhil Masurkar, stated that they plan to legally challenge the suspension. He asserted that all information shared with the media was based on DCGI approval for presbyopia treatment in adults, and results from their Phase 3 clinical trial conducted in India.
Concerns over Entod's product claims
The DCGI had initially granted permission to Entod in August, for the production and marketing of its presbyopia treatment. However, on September 5, the regulator issued a notice regarding the company's claims about their product. The DCGI order stated that there was a risk of misleading the public with claims for which no approval had been given.
Entod's clinical trials and DCGI's response
Entod reported that during the clinical trials of their ophthalmic solution, subjects did not wear any glasses to participate. The DCGI questioned this claim, stating that no approval was given for any such claim that the eye drop could enhance near vision without the need for reading glasses. The regulator emphasized that Entod had attempted to justify claims for which no approval had been granted.
DCGI's letter to Entod on approval suspension
In a letter to Entod, the DCGI announced the suspension of approval until further notice. The letter read, "Considering the public interest, the permission dated August 20, 2024 issued to manufacture and market of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% is hereby suspended till further order under the provisions of rule 84 of the New Drugs and Clinical Trials Rules, 2019."
