In a follow-up to the suspension of the licence of Mumbai-based pharmaceutical company ENTOD Pharmaceuticals by the Drugs Control General of India (DCGI) last month, preventing it from manufacturing and marketing its eye drops, “PresVu”, the drug regulator has now directed the Food and Drugs Control Administration of Gujarat to take “appropriate action” against the company as per the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.
The DCGI issued the directive to FDCA Gujarat, following a complaint filed before it by K.V. Babu, a public health activist and an ophthalmologist himself, last month.
Entod Pharmaceuticals, which had launched the prescription eye drops, named PresVu, claiming it to be a “proud Indian innovation”, for the treatment of Presbyopia or difficulty in near vision, had been in the eye of a storm last month when it was pulled up by the apex drug regulator for making overreaching claims .
On September 4, Entod Pharmaceuticals 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 Pharmaceuticals, by tweeting about the drug (which is a prescription drug), had committed a gross violation of Section 3(d) of Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.
Section 3(d) of the said Act says that none shall publish any advertisement referring to the use of a drug for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule. There are 54 diseases/disorders/conditions, specified in the said Schedule and no. 11 in the list is “Diseases and disorders of the optical system”. Presbyopia is a disorder of the optical system and hence the tweet, publicising the drug, is a contravention of the DMR(OA) Act, was the contention 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 said 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 Drugs Standard Control Organization (CDSCO), had on September 10, suspended Entod’s licence, till further orders, for making tall claims about the drug, for which it did not have the prior approval of the Central licensing authority.
In the permission given to the company, the indication for the drug was “for the treatment of presbyopia in adults”. However, Entod went a step ahead, when it claimed through its tweet that the drug will help people “eliminate” reading glasses.
Published – October 06, 2024 01:23 pm IST