The Central Drug Standards Control Organisation (CDSCO) took issue with ENTOD Pharmaceuticals’ assertion that their eye drop can help presbyopia sufferers become less dependent on reading glasses. On Wednesday, the company’s authorisation to produce and market the product was suspended. ENTOD Pharmaceuticals is based in Mumbai. Sources claim that health ministry officials took this seriously because of concerns about product misuse. We’ll discuss it in more detail below.
Guide on CDSCO: An India’s Guardian of Drug Safety
As designated by the Drugs and Cosmetics Act, the Central Government has delegated some tasks to the Central Drug Authority, the Central Drugs Standard Control Organisation (CDSCO). Under its jurisdiction are thirteen port offices, six zonal offices, four sub-zonal offices, and seven laboratories.
Control over drug imports, approval of novel drugs and clinical trials, meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and approval of specific licenses as the CDSCO headquarters exercises Central License Approving Authority are among the organisation’s primary regulatory responsibilities.
Proceed with CDSCO registration to ensure your pharmaceutical products comply with regulator standards to avoid suspension like ENTOD Pharmaceutical Limited faced.
Why did CDSCO Revoke Approval for Presvu Eye Drops?
The Indian pharmaceutical authority revoked ENTOD Pharmaceutical Limited’s approval to produce a particular kind of eye drop, citing the business’s unauthorised claim to market the product as a medication that helps presbyopia sufferers become less dependent on reading glasses.
The Drugs Controller General of India’s directive dated September 10, which Mint examined, states that the eye above drops have not been cleared for any claim that they can lessen the need for reading glasses in India and that the “permission is suspended” until further orders are received. When the eye drops were certified as a “prescription drug,” the regulator claimed that the promotion raised questions regarding the product’s safety and usage as an over-the-counter medication.
ENTOD Pharmaceuticals’ chief executive officer, Nikkhil K Masurkar, stated that the business has not misrepresented any information on Presvu eye drops or acted unethically. The company intends to contest the directive in court.
The Drugs Controller General of India permitted the company on August 20 to produce and sell PresVu, an ophthalmic solution containing pilocarpine hydrochloride (USP 1.25% weight in volume) for treating adult presbyopia. In an advertisement released on September 3, the company stated that it is the “first eye drop in India specifically developed to reduce dependency on reading glasses” for presbyopia individuals.
What are the Claims Made by the Regulator?
A day later, the regulator sent notice to the company on several claims, and on September 5, it reviewed the response.
- Claim 1: The first claim is that these eye drops were “the first in India to reduce the need for reading glasses.”
Company Response: India has not approved any additional eye drops for the treatment of presbyopia.
- Claim 2: “Without the need for reading glasses, this non-invasive option to improve near vision is offered by this eye drop.”
Company Response: Participants in the clinical experiment did not wear spectacles.
- Claim 3: Within 15 minutes, the medication can offer a cutting-edge substitute that improves near eyesight.
Company Response: A physician assessed the medication compared to the reading glasses.
According to the regulation, the approved eye drops treat adult presbyopia; they are not intended to improve close vision to the point where reading glasses are unnecessary.
The drug regulator’s final ruling stated, “After perusing your reply, you failed to respond to the queries put to you.” “You attempted to defend the product’s claims, for which no approval was given. The Central Licensing Authority has not granted you any previous authorisation to make these claims for the product above.
According to the New Drugs and Clinical Trials Rules, 2019, the company has “violated the condition of the permission” granted to you for the manufacture and marketing of the medication, according to the regulator. The regulator stated, “There is a possibility that the public will be misled by the claims made by you for which no approval was granted,” quoting the Drugs and Cosmetic Act of 1940.
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CDSCO Suspends ENTOD’s License Approval for Eye Drops
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Further Claims
Nikkhil K Masurkar, the chief executive of ENTOD, stated that the DCGI has not specifically referenced any Drugs and Cosmetics Act violations in support of this action. We have chosen to contest this suspension in court to obtain justice. Our battle will not only make cutting-edge medications accessible in India but also inspire other pharmaceutical entrepreneurs and MSME businesses to carry on the research effort in the country without encountering the same difficulties, he claimed.
“The basis for our approval by DCGI was a valid controlled clinical trial with 234 patients, which successfully demonstrated the safety and efficacy of these eye drops in presbyopia patients. These patients used the drops without eyeglasses and could read more lines on the Snellen chart, a measure of near-vision improvement.
Note: Presbyopia is the gradual loss of one’s eyes’ capacity to focus on close things. It’s a regular, frequently inconvenient aspect of ageing. Presbyopia typically starts to show in one’s early to mid-40s and gets worse until one is about 65 years old.
You may have presbyopia when you have to hold books and newspapers at arm’s length to read them. A simple eye exam can confirm presbyopia. With contact lenses or glasses, you can treat the condition. You may also think about having surgery.
For the past three years, these eye drops with the same concentration and active component have been sold in the US after receiving FDA approval and without significant issues. He claimed, “FDA did not take any action regarding the company’s marketing in the United States.”
CDSCO on Entod Pharmaceuticals Offering Presvu Eye Drops
According to the CDSCO, the company violated the New Drugs and Clinical Trial Rules, 2019 by making claims for the drug without obtaining approval from the Central Licensing Authority. It further stated that approval had been postponed due to the public interest and the possibility of the general public being deceived by these representations.
ENTOD Pharmaceuticals said in a statement on Wednesday, September 11, that it would file a lawsuit to contest this ban. CEO Nikkhil K. Masurkar stated that the company has not provided the public or media with any misleading information on Presvu Eye Drops or other unethical practices.
According to the statement, “public imagination led to an unusual escalation for which ENTOD Pharmaceuticals is not responsible” due to widespread media reporting on the new product launch. It added that a legitimate controlled clinical trial involving 234 patients was the foundation for the Drug Controller General of India (DCGI) approval, successfully demonstrating the eye drops’ safety and effectiveness in treating presbyopia.
Know the Benefits of Registration under CDSCO
There are numerous benefits to Registration under CDSCO, some of which are listed below:
- Verify that the manufactured and imported medications are healthy and safe for us.
- Control the market’s supply of medications and cosmetics.
- Make the markets for drugs and cosmetics user-safe.
- Boost the importer’s and manufacturer’s reputation in the marketplace.
- Boost the importer’s and manufacturer’s reputation in the market.
- It enhanced dependability and trustworthiness.
- The government can monitor the actions of the importer and manufacturer.
- Customers will undoubtedly benefit from a clean and safe medicine and cosmetics industry.
Conclusion
The CDSCO’s decision to suspend ENTOD Pharmaceuticals’ ability to produce and market eye drops is a clear reminder of the significance of pharmaceutical quality control and strict adherence to production procedures. Maintaining the highest standards of medication safety is essential for both domestic and foreign markets as India grows as a central pharmaceutical hub on a global scale.
The future for ENTOD Pharmaceuticals is resolving compliance concerns, obtaining regulatory approval, and re-establishing its standing as a reliable supplier of ophthalmic drugs.
Visit our website https://corpbiz.io/ and stay informed about the latest developments in pharmaceutical regulations to ensure your products meet compliance standards.
Frequently Asked Questions
What is the CDSCO?
The national regulating organisation for medicines and medical devices in India is the Central Drugs Standard Control Organisation (CDSCO). It supervises medication regulation, monitoring, and approval, ensuring they adhere to quality, safety, and efficacy criteria. It enforces adherence to Good Manufacturing Practices and is run by the Ministry of Health and Family Welfare (GMP).
Why did the CDSCO suspend ENTOD Pharmaceuticals' license?
The CDSCO suspended ENTOD Pharmaceuticals' license due to quality control breaches and non-compliance with Good Manufacturing Practices (GMP). Following an inspection, several batches of eye drops did not adhere to regulatory requirements, which could have risked customers' safety.
What were the specific issues identified in ENTOD's eye drops?
During the inspection, quality control violations, including possible contamination, incorrect formulation, and non-compliance with safety and efficacy criteria, were found in ENTOD Pharmaceuticals' eye drops. These flaws made people wonder if the products were safe for consumers.
How does the CDSCO ensure the quality and safety of pharmaceutical products?
The CDSCO makes certain that pharmaceutical products are safe and of high quality by:
· Carrying out regular inspections of production plants.
· Implementing GMP adherence.
· Medication approval or rejection based on results from clinical trials.
· We will be looking for lousy drug responses and suspending or recalling products that don't adhere to safety regulations.How standard are suspensions like this in the pharmaceutical industry?
Suspensions and regulatory actions are not unusual in the pharmaceutical sector, significantly when quality control is compromised or regulatory criteria are not being followed. Regulatory agencies like the European Medicines Agency (EMA), the US FDA, and CDSCO periodically carry out inspections to guarantee the safety of pharmaceutical products.
Read Our Article: CDSCO’s National Single Window System Portal
