India Suspends ENTOD Pharmaceuticals’ PresVu Eye Drops Over Safety Concerns
New Delhi, India – The Drugs Controller General of India (DCGI) has suspended the product PresVu, produced by ENTOD Pharmaceuticals, due to safety concerns and unauthorized promotion. The company failed to respond to queries about the product, which had no approval for its promotion.
Unauthorized Promotion
The Union Ministry of Health and Family Welfare stated that the unauthorized promotion of PresVu (1.25% Pilocarpine w/v) raised doubts about its safety and misuse as an over-the-counter drug. The product is approved only as a prescription drug.
Company’s Response
ENTOD Pharmaceuticals’ CEO, Nikkhil K Masurkar, denied any unethical or false presentation of facts. He stated that all information shared with the media was based on approved indications and clinical trial data. The company also mentioned that some media reports did not represent their views.
Medical Experts’ Opinions
Medical experts have expressed concerns about the effectiveness and safety of PresVu. Dr. Charu Mithal from Max Hospital and Dr. Samir Sud from Sharp Sight Eye Hospitals explained that while pilocarpine can help with reading, it is an imperfect and temporary solution. Dr. Tushar Grover from Sir Ganga Ram Hospital noted that pilocarpine has been used for decades in glaucoma treatment but questioned its safety for widespread use in presbyopia.
Doubts Revealed
ENTOD Pharmaceuticals -: ENTOD Pharmaceuticals is a company that makes medicines, especially for eye care. They are based in India and produce various eye drops and other treatments.
PresVu Eye Drops -: PresVu Eye Drops are a type of medicine made by ENTOD Pharmaceuticals. They are used to treat eye conditions, but there are concerns about their safety.
Drugs Controller General of India (DCGI) -: The Drugs Controller General of India (DCGI) is a government official who makes sure that medicines in India are safe and effective. They can stop the sale of medicines if there are problems.
Union Ministry of Health and Family Welfare -: The Union Ministry of Health and Family Welfare is a part of the Indian government that looks after the health of people in India. They make rules about medicines and healthcare.
Over-the-counter solution -: An over-the-counter solution is a medicine that you can buy without a doctor’s prescription. It is usually safe for most people to use on their own.
Nikkhil K Masurkar -: Nikkhil K Masurkar is the CEO of ENTOD Pharmaceuticals. A CEO is the person who is in charge of running a company.
Pilocarpine -: Pilocarpine is a chemical used in some eye drops to treat certain eye conditions. It helps to make the pupils smaller and can help with vision problems.
Presbyopia -: Presbyopia is a common eye condition that happens as people get older. It makes it hard to see things up close, like reading a book or looking at a phone.
