In a follow-up to the suspension of the licence of Mumbai-based pharmaceutical firm ENTOD Prescription drugs by the Medication Management Basic of India (DCGI) final month, stopping it from manufacturing and advertising and marketing its eye drops, “PresVu”, the drug regulator has now directed the Meals and Medication Management Administration of Gujarat to take “appropriate action” in opposition to the corporate as per the Medication and Magic Treatments (Objectionable Commercial) Act, 1954.
The DCGI issued the directive to FDCA Gujarat, following a criticism filed earlier than it by Ok.V. Babu, a public well being activist and an ophthalmologist himself, final month.
Entod Prescription drugs, which had launched the prescription eye drops, named PresVu, claiming it to be a “proud Indian innovation”, for the therapy of Presbyopia or problem in close to imaginative and prescient, had been within the eye of a storm final month when it was pulled up by the apex drug regulator for making overreaching claims .
On September 4, Entod Prescription drugs tweeted, tagging Prime Minister Narendra Modi, that “PresVu was the first DCGI-approved proprietary prescription eye drops to eliminate the need for reading glasses”
Dr. Babu had written to the DCGI that Entod Prescription drugs, by tweeting concerning the drug (which is a prescription drug), had dedicated a gross violation of Part 3(d) of Medication and Magic Treatments (Objectionable Commercial) Act, 1954.
Part 3(d) of the mentioned Act says that none shall publish any commercial referring to the usage of a drug for the analysis, treatment, mitigation, therapy or prevention of any illness, dysfunction or situation specified within the Schedule. There are 54 illnesses/issues/situations, specified within the mentioned Schedule and no. 11 within the checklist is “Diseases and disorders of the optical system”. Presbyopia is a dysfunction of the optical system and therefore the tweet, publicising the drug, is a violation of the DMR(OA) Act, was the competition raised.
“I had, through an RTI recently, sought to know the status of the complaint I had filed before the DCGI that the pharma firm had violated provisions of DMR Act,” says Dr. Babu.
The RTI reply from the DCGI mentioned that “With respect to contravention of DMR Act,1954, the matter was forwarded to FDCA, Gujarat vide letter Dated 25.09.2024 to take appropriate action as per the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.”
“The fact that the DCGI concurs with the specific violation of law that I had raised, aggravates the gravity of the situation that Entod pharmaceuticals finds itself in,” he says.
The Central Medication Customary Management Group (CDSCO), had on September 10, suspended Entod’s licence, until additional orders, for making tall claims concerning the drug, for which it didn’t have the prior approval of the Central licensing authority.
Within the permission given to the corporate, the indication for the drug was “for the treatment of presbyopia in adults”. Nevertheless, Entod went a step forward, when it claimed by way of its tweet that the drug will assist individuals “eliminate” studying glasses.
Revealed – October 06, 2024 01:23 pm IST
