After stents, FDA seeks crackdown on cataract lens prices

After cracking down on pricing of stents and cardiac catheters, the Maharashtra Food & Drug Administration (FDA) has found intraocular lenses and several other medical devices ranging from the humble urine bags to oxygen masks too overpriced.

Intraocular lenses used in cataract surgeries are being sold at a rate which is 10 times higher than the market price, FDA officials said in a report submitted to the union department of pharmaceuticals.

Consumers are charged Rs8,000 for a brand of intraocular lens, which has a landing cost of Rs800. Another brand which costs Rs7,000, is being sold for Rs11,350, the FDA found.

After the National Pharmaceutical Pricing Authority capped the prices of cardiac stents, authorities like the FDA, the legal metrology department and non-government organisations have demanded a price cap on other medical devices too.

The state FDA has surveyed 15 brands of intraocular lenses used in India, and found that cost for the retailer or the hospital starts from Rs350 and goes up till Rs15,200 for a lens. The cost to the patient, however, ranges between Rs5,800 and Rs26,550. The profit, according to the FDA report accessed by sections of the media, including The Indian Express, shows a 200 to 300 per cent difference between the purchase cost and the maximum retail price (MRP).

According to the report, AcrySof IOL lens, a product of US manufacturer Alcon, was imported for Rs2,737 in India. Its selling price for wholesalers is Rs6,500, but the cost to patients at the MRP is Rs18,500, almost seven times higher than the landed cost.

In case of Ultima Plus Natural, manufactured by Care Group, the hospital purchased it for Rs1,500, while its MRP was Rs9,500, at a profit of 533 per cent. FDA officials said that they had sent the report with the investigation report on balloons (used to inflate the artery to insert stents in angioplasty) and guiding catheters (a thin tube used to guide stents through arteries) to the Maharashtra government.

In a letter written to the National Pharmaceutical Pricing Authority (NPPA) on 5 June, the then FDA commissioner Dr Harshdeep Kamble said that a study done by his team found a "huge difference of 200-300 per cent" between hospital's purchase price for lenses and its maximum retail price (MRP). The FDA found, for instance, that the importer's price for a particular lens was Rs2,737, but its price was Rs6,500 for the hospital and Rs18,500 for patients.

Lenses are medical devices implanted inside the eye to replace the eye's natural lenses during cataract surgery.

"Patients suffer unnecessary financial burden due to such overpricing. Moreover, many patients in India pay for medical expenses out of their own pockets," a senior FDA official told The Times of India.

FDA officials said that a discussion during the state assembly's winter session in 2015 focused on overcharging of various surgical equipment, instruments and medical devices. A study was subsequently carried out and a report was submitted to the state on 21 November 2016. The study found that the MRP of urine bags was 500 per cent higher than the cost at which it was supplied to hospitals. Similarly the cost of oxygen bags was 300 times higher.