NEW DELHI: More trouble is in store for ENTOD Pharmaceuticals, whose public claims that their new eye drop reduced dependency on reading glasses for those suffering from presbyopia, an age-related vision condition, led India’s drug regulator to suspend their manufacturing and marketing permission.
Now, the Central Drugs Standard Control Organisation (CDSCO) has directed the Gujarat drug control authority to act against the company for violating the Act prohibiting the advertisement of certain drugs to treat some diseases and disorders.
The CDSCO direction to the Food and Drugs Control Administration (FDCA), Gujarat, came after RTI activist K V Babu flagged the violation under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
Under the DMR Act, advertisements for drugs for 54 diseases that fall under the schedule are prohibited. The schedule also states clearly that no company can advertise cures or claims about diseases and disorders of the optical system.
Presbyopia is one of the 'disorders' of the optical system, and any ad of a drug for the same contravenes the DMR (OA) Act 1954, section 3(d).
The company, which got CDSCO approval for its eye drop, PresVu, on August 6, not only held a press conference on September 3 but also posted on X, previously Twitter, that the eye drops eliminate the need for reading glasses. The September 4 post has now been deleted.
In the tweet, which they had also tagged Prime Minister Narendra Modi, they posted, “A proud Indian innovation that could help millions of Indians see better and that too at an affordable price.”
In their statement to the media, they claimed that the eye drop offers an advanced alternative that augments near vision within 15 minutes.
Flagging the tweet to the CDSCO in his September 10 RTI, Babu, an ophthalmologist, said the company cannot advertise its eye drop, PresVu, as per the DMR Act.
Following Babu’s RTI, the CDSCO asked the Gujarat drug authority to “take appropriate action” under the DMR Act, 1954, on September 25.
“The company held a press conference and tweeted about a prescription drug that cannot be advertised. It is a clear violation of the DMR Act. Ours is a country where there is a gap between legal and real-life situations of dispensing even prescription drugs. In this context, the decision of CDSCO to forward my communication to FDCA, Gujarat, to take ‘appropriate action as per DMR (OA) Act 1954’ is most welcome,” Babu told this paper.
The CDSCO, taking serious note of the unauthorised promotion of the product, issued a notice on September 10 to the Mumbai-headquartered company that their permission to manufacture and market has been suspended till further notice.
The New Indian Express was the first to report that the Drug Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, had sought an explanation from the company for its claims that raised doubts.
Following the suspension of its eye drop, the company’s CEO, Nikkhil K Masurkar, blamed the media and said they had “decided to challenge the suspension in the court of law to get justice.”
However, after a meeting with DCGI, Masurkar clarified that the eye drop is a “therapeutic option, available only by prescription from the registered medical practitioner.”
“PresVu eye drops are not intended to replace reading glasses or non-invasive options for presbyopia. It's a therapeutic option, available ONLY by prescription from the registered medical practitioner, for patients diagnosed with presbyopia, as assessed by an eye doctor," Masurkar said. He also appealed to the DCGI to reconsider the suspension. He again blamed the media for creating the hype.
The DMR (OA) 1954 prohibits the advertisement of certain drugs to treat certain diseases and disorders. It 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 diseases, disorder or condition."
Among the drugs that cannot be advertised include drugs for cancer, diabetes, diseases and disorders of the brain, uterus, menstrual flow, nervous system epilepsy, fits, gallstones, kidney stones and bladder stones, heart diseases, high and low blood pressure, venereal diseases, leprosy, obesity, sexual impotence, and tuberculosis.