Entod Pharmaceuticals Faces Regulatory Challenges

New Delhi: Further challenges mount for Entod Pharmaceuticals as the Central Drugs Standard Control Organisation (CDSCO) has directed the Food and Drugs Control Administration of Gujarat to take action against the pharma firm for violating the Drugs and Magic Remedies (DMR) Act by advertising its treatment for Presbyopia, PresVu, as a potential replacement for glasses altogether.

The directive came after RTI activist K V Babu and a practicing ophthalmologist flagged the violation under the Drugs and Magic Remedies (Objectionable ) Act, 1954.

As per the DMR Act, for drugs for 54 diseases and disorders that fall under the schedule are prohibited. The schedule explicitly prohibits companies from promoting cures or making claims related to diseases and disorders affecting the optical system.

Presbyopia, an eye condition which makes it harder to see objects up close as people age, is one of the 'disorders' of the optical system, and any of a drug for the same breaches Section 3(d) of the DMR (OA) Act 1954.

The issue stemmed after the company, in a statement, while launching its ophthalmologic product, Pilocarpine Hydrochloride Ophthalmic solution USP 1.25% w/v in August 2024, 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.”

The company had held a press conference where it announced the DCGI approval of the product and further posted on X, previously Twitter, claiming “#PRESVU is the 1st DCGI approved proprietary Rx eyedrops to eliminate the need for reading glasses.”

Also Read: Fact Check: Can Entod Pharma's PresVu get rid of reading glasses?

However, this claim met with regulatory hurdles following Babu’s RTI. PresVu's marketing and manufacturing license was suspended in September, shortly after its approval by the Drug Controller General of India (DCGI), due to concerns over misleading promotional claims.

ENTOD was accused of overselling the product’s benefits, particularly in suggesting that it could completely eliminate the need for reading glasses, which was seen as an exaggerated claim by health authorities.

Also Read: DCGI Suspends Permission To Entod Pharma To Manufacture, Market PresVu, What Next For The Company?

After a meeting with DCGI, the company’s CEO, Nikkhil K 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 mentioned.

Masurkar blamed the media and stated that they had “decided to challenge the suspension in the court of law to get justice.” He also appealed to the DCGI to reconsider the suspension. He again blamed the media for creating the hype.

Meanwhile, welcoming the CDSCO directive, Babu told TOI, “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.”