NEW DELHI: The Central Drugs Standard Control Organisation has forwarded a complaint against Entod Pharmaceuticals for violating the Drugs and Magic Remedies (DMR) Act to the state drug regulatory authority of Gujarat, where the company is based, to take action. The complaint stated that the press conference to announce the launch of the drug and a tweet by the company were meant to promote the drug to the public, which was prohibited by the DMR Act.
The DMR Act (section 3-d) prohibits advertising for a list of conditions or diseases including diseases and disorders of the optical system. Presbyopia, an eye condition which makes it harder to see objects up close as people age, would fall under disorders of the optical system and hence advertising any drugs for this condition would be prohibited under the DMR Act, argued Dr Babu KV an RTI activist and a practising ophthalmologist.
“The company conducted a press conference and even tweeted about a prescription drug, which would amount to promotion. Under DMR Act, ads of such prescription drugs for conditions that come under the scheduled list in the Act can only be sent confidentially in the manner prescribed in the law to a registered medical practitioner. In our country, there is a gap between legal and real-life situations of dispensing even prescription drugs. In this context, the decision of the CDSCO to forward my complaint to FDCA Gujarat to take appropriate action as per DMR (OA) Act 1954 is most welcome,” said Dr Babu.
The DMR Act states that no person shall take any part in the publication of any advertisement referring to any drug in terms which suggest or are calculated to lead to the use of that drug for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the schedule. The 54 diseases or disorders/conditions specified in the schedule include disorder of the optical system.
Currently, Entod Pharmaceuticals permission to manufacture and sell eye drops, claimed to reduce dependency on reading glasses for presbyopia, has been suspended following the company’s unapproved claims about the product’s benefits.
In its statement while launching the product last week, the company stated: “PresVu is the first eye drop in India developed to reduce dependency on reading glasses for individuals affected by presbyopia, a common age-related condition that typically impacts those over 40.” It only talked of reducing dependency and not about eliminating reading glasses. The tweet, however, said: “#PRESVU is the 1st DCGI approved proprietary Rx eye drops to eliminate the need for reading glasses.”
The company blamed the media for the exaggerated claims. It claimed that widespread media interest in the therapy “led to sensationalization of the story”. But most media reports only said what the company claimed in its tweet.
