- By Imran Zafar
- Wed, 11 Sep 2024 06:45 PM (IST)
- Source:JND
The apex drug regulator suspended the manufacturing and marketing of eye drops PresVu, which claimed to reduce the need for reading glasses, due to unauthorised assertions. The Drugs Controller General of India (DCGI) revoked approvals granted to Mumbai-based Entod Pharmaceuticals after determining that the company had made bold, unapproved claims about the product's effectiveness for treating presbyopia.
Presbyopia is a common condition among middle-aged and older adults that impairs near vision, according to the National Eye Institute. Entod Pharmaceuticals' eye drops, Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent, had been approved by the DCGI on August 20 for treating presbyopia, but the company promoted the drops as being able to eliminate the need for reading glasses, a claim not supported by the approval.
In a September 10 order, the DCGI outlined the violations under the New Drugs and Clinical Trials Rules, 2019. The regulator stated that the company had failed to receive approval for claims such as enhancing near vision within 15 minutes and offering a non-invasive alternative to reading glasses.
Despite the company’s response to the DCGI’s request for clarification on September 4, the regulator found that their justifications lacked sufficient backing.
The DCGI also noted that misleading public claims in the media could have a significant impact, potentially causing confusion among consumers. As a result, the approval for the eye drops has been suspended under Rule 84 of the New Drugs and Clinical Trials Rules, 2019, pending further investigation.