Entod pharma takes down tweet, after complaint about violation of regulation on drug ads
After TOI mailed Entod Pharmaceuticals for a comment on the issue, the tweet which was posted on September 4 night, and which was up till 11 am on Wednesday, was taken down.
The Drugs and Magic Remedies (DMR) Act (section 3-d) prohibits advertising for a list of conditions or diseases which includes 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 drug cannot be used for all people with presbyopia. There are several contraindications that need to be kept in mind. Hence their claim in the tweet that their drug will eliminate the need for reading glasses is an exaggeration,” said Dr Babu KV who has complained to the CDSCO and the health ministry seeking action against the tweet. He added that while the approval given to Entod’s drug stated “indicated for the treatment of presbyopia in adults”, in its tweet Entod claimed it is an approved drug “to eliminate the need for reading glasses”. The effect of the drug is for just about six hours and hence it is unlikely to eliminate reading glasses, he pointed out.
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 includes disorder of the optical system.
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 as claimed in the tweet. The company blamed the media for the exaggerated claims. It claimed that widespread media interest in the therapy “led to sensationalisation of the story” though the most media reports only said what the company claimed in the tweet.
Entod’s response to TOI stated: “We at ENTOD Pharmaceuticals hereby declare that we have not made any of the unethical or false presentation of facts to the media or public when it comes to Presvu Eye Drops. All facts disclosed to the media are strictly on the basis of the recent DCGI approval for treatment of presbyopia in adults and the results of the phase 3 clinical trial conducted by us in India. The official company line is that these eye drops are the first DCGI approved eye drops for treatment of presbyopia in adults. Claims that these can eliminate the need for reading glasses or used for other eye conditions is not the opinion of the company or any of its spokespeople. Wherever we have found inconsistencies in the facts on social media we have immediately taken action and clarified our official stand.”
The Central Drugs Standard Control Organisation (CDSCO) did not respond to queries that TOI sent regarding the complaint it has received regarding the violation of the DMR Act.
