Maha FDA Urges CDSCO To Place Intraocular Lenses Under NLEM To Prevent Overcharging

Mumbai, 21 Dec 2018: Maharashtra Food and Drug Administration (FDA) has submitted its study report on the overcharging of intraocular lenses at the point of care to the Central Drugs Standard Control Organisation (CDSCO). The purpose of the study is to bring intraocular lenses under the National List of Essential Medicines (NLEM) to protect patients from being overcharged in hospitals.

Intraocular lenses which falls under the ambit of notified devices and widely used in cataract surgeries are being overcharged 10 times higher than the market price at the point of care. Consumers are charged Rs. 8,000 for a brand of intraocular lens which has a landing cost of Rs. 800.

“Cardiac stents and knee implants have been brought under the purview of NLEM and prices have been capped subsequently. The state FDA has submitted its study report on intraocular lenses and the central government is in the process of bringing it under price control,” informed Maharashtra FDA Commissioner Dr Pallavi Darade.

After the National Pharmaceutical Pricing Authority (NPPA) capped the prices of cardiac stents, Maharashtra FDA, the legal metrology department and non-government organisations (NGOs) have been demanding a price cap on implants like intraocular lenses.

According to sources, cases have been detected in the past by the state FDA wherein hospitals, distributors and manufacturers have connived to change the MRP of balloons (used to inflate the artery to insert stents in angioplasty) and guiding catheters (a thin tube used to guide stents through arteries) to fleece patients and make high profits.

Experts have been pushing forth the idea for quite some time now that intraocular lenses, catheters, orthopedic implants, dental implants and ophthalmic medication need to be brought under National List of Essential Medicines (NLEM) to make it affordable for the common man.

Intraocular lenses (IOLs) are medical devices that are implanted inside the eye to replace the eye's natural lens when it is removed during cataract surgery. IOLs also are used for a type of vision correction surgery called refractive lens exchange.

Government has recently notified gowns and drapes to list of devices regulated under the new medical device rules – 2017 (MDR - 2017). However, high risk devices like defibrillator and pacemaker continue to be imported and manufactured without regulations. Association of Indian Medical Device Industry (AiMeD) also had suggested a list of 38 medical devices categories to be regulated on priority considering higher proportion of risk in consultation with experts and medical professionals.

As of today, 27 categories of medical devices are regulated which cover around 400 medical devices amongst the 5,000 odd unregulated medical devices in the country which pose an alarming risk to patients in the country.

Pharmabiz had earlier reported that a racket of forcing manufacturers of medical devices to sell their products only to distributors and hospitals at low prices bypassing retail medical stores has become rampant. The practice of selling emergency medical devices by hospital managements at exhorbitant prices to patients is also flourishing.

Sources in the healthcare industry have revealed that the practice of selling these products to stockists and they in turn selling the products to hospitals at high prices and at high margin is prevalent for some time now. It has also been found that hospitals have been taking advantage of this situation as patients have no idea about neither the cost nor the use of such devices. Simple devices like oxygen mask, IV cannula and infusion therapy products are priced as high as 10 to 30 times more when it reaches the point of care.Pharmabiz