By Dr. Gyan Pathak
Claimed to be an innovative eye drop named PresVu capable of curing vision defect within 15 minutes replacing reading glasses has itself fallen in the eye of the storm even before its scheduled launch for the market in October this year.. The drop has already got regulatory approval from the Drug Controller General of India (DCGI), but taking into account the general doubt over the effectiveness of the drug, and also accusation against the producer of the drop, ENTOD Pharmaceuticals, of misrepresentation as well as unethical and false claims, DCGI had to ask the company afresh for a detailed explanation.
This issue again highlights the way drugs have been pushed in the market on false promises, and approval of drug regulators that amounted cheating of the suffering public even at the cost of their life. We have just recently seen how the Supreme Court of India had to interfere in the case of Patanjali of Ramdev, who sold drugs to the people on false promises and representation. It has made reliability of drug regulation under the Modi government under question, and the general allegation is that the government has been favouring companies in their profiteering.
Now, even after giving approval for the drop, DCGI has asked for further explanation, while ENTOD has said that they stand by their claim and the company had got approval for the drop which followed an earlier recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
“After detailed deliberation, the committee recommended for grant of permission for manufacture and market of Pilocarpine Hydrochloride solution USP 1.25%w/v subject to the condition that the firm should conduct Phase IV clinical trial. In addition to the above, the firm should fulfil the requirements for CMC data. Accordingly, the firm should submit the Phase IV clinical trial protocol within three months from date of approval to CDSCO for further review by the committee,” the minutes of the SEC held on March 27 read.
However, the CDSCO website has no information that the ENTOD pharmaceuticals supplied the data required for the final approval. The latest order of DCGI seeking further detailed explanation from the company suggest that it is yet to get the data required, though the earlier approval was subject to submission of the Phase IV trials.
The question is whether DCGI will put on hold its approval for the eye-drop? Only time will tell. ENTOD representatives have been reported claiming that they have provided all the required explanation to DCGI, which is yet to be confirmed by the DCGI officials.
The news about the eye-drop has created great sensation in India, which also attracted attention of ophthalmologists, doctors, and experts, who in their reaction said that the short and long term side effects of the eye drop is yet unknown.
Glaucoma patients already use this medicine, and there is nothing innovative about the drug. It has short term benefit but long term usage can be hazardous, Experts claim, and say that the claims of the pharmaceutical company is misrepresentation and unethical.
ENTOD’s CEO had said in a written statement that “they have not made any of the unethical or false representation of facts to the media or public when it comes to PresVu Eye Drops,” adding “All facts disclosed to the media are strictly based on the approved indication for treatment of presbyopia in adults and the phase 3 clinical trial data generated by us.” As for the opinions and claims published in media, the CEO said, do not represent those of ENTOD Pharmaceuticals or any of its spokespeople.
However, the press statement issued earlier by ENTOD has said that the PresVu eye drops, which have received a “final approval” from DCGI, utilise “advanced dynamic buffer technology to swift adapt to hear pH, ensuring consistent efficacy and safety for extended use, keeping in mind that such drops will be used for years at a stretch.”
The drops contain synthetic pilocarpine and not plant extract containing pilocarpine, the representative of ENTOD has clarified. The drug is in use since its discovery in 1874. However, “Our product is repurposed pilocarpine for presbyopia in a different strength from the one used for glaucoma, and a much lesser dose than that.”
It should be noted that presbyopia is a condition, an age-related eye condition, under which a patient finds it difficult to see things closer to their eyes – generally over 40 years of age. That is why they need reading glasses. The drug is being launched with a promise that it would replace reading glasses within 15 minutes.
Nevertheless, reports have appeared quoting the top DCGI officials that ENTOD Pharmaceuticals’ claims are “unethical and false representation of facts” and explanation have been asked from the company. At best, medical practitioners find the drop only an “imperfect and temporary solution.”
In the meantime, the apex ophthalmologists’ body, All India Ophthalmological Society (AIOS), has set up an expert group to review PresVu eye drop and to develop a guideline on the side-effects, especially keeping in mind the ‘potential inappropriate marketing’ and possible ‘indiscriminate use’. AIOS has said that the approval of the drug and its subsequent use by people may lead to a “public health challenge”. (IPA
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