NEW DELHI: India’s drug regulator has suspended manufacturing and marketing permission of Mumbai-based ETOD Pharmaceuticals, which had claimed that their new eye drop could help people reduce dependency on reading glasses for those suffering from presbyopia, an age-related vision condition.
The Central Drugs Standard Control Organisation (CDSCO) had earlier granted the pharma company approval to manufacture and market their eye drop, PresVu, which the company said offers an advanced alternative that augments near vision within 15 minutes.
Taking serious note of the unauthorised promotion of the product, the CDSCO said that their permission to manufacture and market has been suspended till further notice.
This daily 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.
In a tersely written notice dated September 10, the DCGI said, “The unauthorised promotion in the press and over social media had raised doubt on its unsafe use by patients and safety concern for the public. The promotion had raised concern about its use like OTC (over the counter) drugs whereas it is approved as a prescription-only drug.”
In a rebuttal, the company’s CEO, Nikkhil K Masurkar, said, “We at ENTOD Pharmaceuticals at this moment declare that we have not made any unethical or false presentation of facts to the media or public when it comes to Presvu Eye Drops. All facts disclosed to the media were strictly based on the recent DCGI approval for treatment of presbyopia in adults and the results of the phase 3 clinical trial conducted by us in India.”
He blamed the media reports, which he said went viral and public imagination led to an unusual escalation for which ENTOD Pharmaceuticals is not responsible.
Masurkar said they have “decided to challenge this suspension in the court of law to get justice.” Kerala-based RTI activist K V Babu, who had shot a letter to both the DCGI and the Union Health Ministry, told this paper that the company advertised the drugs which fall under the Drugs and Magic Act, 1954 and which is prohibited under section 3(d) that bans advertisement of certain drugs for treatment of certain diseases and disorders. He said the law applies to modern medicine and Ayush drugs.
“I wrote to the DCGI and the union health ministry and flagged the September 4 tweet of the company where it had claimed that the eye drop eliminated reading glass. This is a violation of the DMR Act,” he told TNIE.
The tweet was deleted on Thursday, and Babu, an ophthalmologist, and added that he welcomes the decision of the DCGI before much damage was done.
Experts told TNIE that there are short and long-term side effects of using eye drops, which the company has not shared.
In its order, the drug regulator said the company made claims for the eye drop for which it had not obtained approval from the Central Licensing Authority, thereby violating provisions under the New Drugs and Clinical Trial Rules, 2019.
The DCGI said the Directorate had issued permission on August 20 to manufacture and market Pilocarpine Hydrochloride Ophthalmic Solution for treating presbyopia in adults.
Then, on September 4, the drug regulator asked for an explanation from the company for the claims it made in the press, following which the drug maker also submitted its response.
In response to the claim "first eye drop in India designed to reduce the need for reading glasses", the order stated that the company said there are currently no other eye drops approved for the treatment of presbyopia in India.
"In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent w/v has not been approved for any such claim that it is designed to reduce the need for reading glasses," the order said.
In response to the claim that "this eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses", the company submitted that in the clinical trial conducted, subjects did not wear glasses to participate.
"In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent w/v is approved for the treatment of Presbyopia in adults and is not approved for such claim that these eye drops can enhance near vision without the need for reading glasses," the order said.
In response to the claim that "PresVu can provide an advanced alternative that augments near vision within 15 minutes", the firm stated that one doctor had evaluated the drug product compared to reading glasses.
"In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent w/v is approved for the treatment of Presbyopia in adults and is not approved for such claim that PresVu can provide an advanced alternative that augments near vision within 15 minutes," the order added.
The drug regulator stated that the company had failed to respond to the queries and tried to justify the claims for the product for which no approval was granted.
"...whereas it is clear that you have not obtained any prior approval from the Central Licensing Authority to make such claims for the said drug product as mentioned above. Thus, you have violated the condition No. (vi) of the permission dated 20.08 2024 issued to you for the manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent w/v under the provisions of the New Drugs and Clinical Trials Rules, 2019.
The DCGI, in his order, further said considering the various media reports, there is a likelihood of the general public being misled by the claims made by the company for which no approval was granted.
"Given above and considering the public interest, the permission issued to manufacture and market Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v vide is at this moment suspended till further orders under the provisions of Rule 84 of the New Drugs and Clinical Trials Rules, 2019 of the Drugs and Cosmetics Act, 1940," the order stated.