Medical devices have often come under the scanner for being overpriced. A PIL filed in the Delhi High Court late last year challenged such overpricing with a specific plea that intraocular lenses, among the essential medical devices, be listed under the National Pharmaceutical Pricing Authority.
India has for long been known as the “blind capital” of the world. Around 15 million people here are blind, which is 50 percent of the world’s blind population. According to the data published by the National Programme for Control of Blindness and Visual Impairment, cataract alone accounts for 62.6 percent of all causes of curable blindness in India.
The cataract surgery rate is pinned at above one percent of the total population of the country every year. That means millions of people are getting intraocular lenses implanted each year. But there is a huge gap between the cost of procuring these lenses and the price a patient has to pay for correcting his vision.
The PIL came up for hearing in the Court last week and there was talk of the need for incorporating implantation of intraocular lenses into the definition of a “drug” in the National List of Essential Medicines (NLEM) and price capping it in the interest of public health. The National Pharmaceutical Pricing Authority (NPPA) was set up in August 1997 to act as an independent regulator for the pricing of drugs and ensure availability and accessibility of medicines at affordable prices. The Drug Price Control Orders (DPCO) are issued by the government to declare a ceiling price for essential and lifesaving medicines (as per a prescribed formula) so as to ensure that these medicines are available at a reasonable price to the general public.
The criteria for inclusion of a drug in NLEM includes, among other things—it should be approved/licensed in India; it should be useful in case of a disease which is a public health problem in India; it should have proven efficacy and a safety profile based on valid scientific evidence; it should be cost effective; and it should be stable under storage conditions in India.
The Union Ministry of Health and Family Welfare prepared and released the first NLEM in 1996, consisting of 279 medicines. This list was subsequently revised in 2003 and included 354 medicines. Later in 2011, the list was further revised and had 348 medicines. Till June 2018, 851 medicines (including four medical devices—cardiac stents, drug eluting stents, condoms and intra uterine devices) are regulated under the revised schedule.
Currently intraocular lenses, which fall under the ambit of notified devices and are widely used in cataract surgeries, are being priced ten times higher than the market 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.
Medical experts have been insisting that intraocular lenses, catheters, orthopaedic implants, dental implants and ophthalmic medication be brought into the NLEM in order to make them affordable for the common man.
It is now the High Court’s turn to take a call. – India Legal