Shocking DCGI Directive: Urgent Action Ordered Against ENTOD Pharmaceuticals Over PresVu Eye Drops Claims
In the ongoing controversy involving Mumbai-based ENTOD Pharmaceuticals, the Drugs Control General of India (DCGI) is stepping up actions against the firm. Following last month’s suspension of ENTOD’s license to manufacture and market “PresVu” eye drops, the DCGI has now instructed Gujarat’s Food and Drugs Control Administration (FDCA) to take action under the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954. This directive came after ophthalmologist and health activist Dr. K.V. Babu’s complaint about ENTOD’s claims regarding PresVu—a treatment for presbyopia, or difficulty in near vision.
Dr. Babu argued that a tweet from ENTOD, suggesting PresVu could “eliminate the need for reading glasses,” violated the Act’s Section 3(d). This section prohibits advertising a drug for treating specific medical conditions, including optical disorders. Consequently, ENTOD’s promotion of PresVu was found to violate these regulations.
The Central Drugs Standard Control Organization (CDSCO) had already suspended ENTOD’s license as of September 10th, citing unauthorized claims about the drug’s capabilities beyond the approved use of treating presbyopia. The DCGI’s concordance with the complaint highlights the seriousness of ENTOD’s situation, as it faces potential legal consequences for its overreaching assertions.
Original Story https://www.thehindu.com/sci-tech/health/presvu-eye-drops-claim-dcgi-directs-fdca-gujarat-to-take-appropriate-action-against-entod-pharmaceuticals/article68724257.ece
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