Regulate prices of intraocular lenses: FDA report to Maharashtra govt

The FDA report, sent to the Maharashtra government, the Drug Controller General of India (DCGI) and the NPPA, has stated that intraocular lens must be included in the definition of ‘drug’ under Drug Price Control Order 2013

Written by Tabassum Barnagarwala | Mumbai | Published:June 10, 2017 5:17 am
Maharashtra FDA, Food and Drug Administration, intraocular lenses, FDA price regulation, maharashtra govt, india news, latest news, indian express Intraocular lens are used for cataract surgeries to improve sharpness of vision. (Representational Image)

After stents and catheters, the Maharashtra Food and Drug Administration (FDA) has raised an alarm over the sale of intraocular lenses, in which manufacturers, distributors, and hospitals are allegedly pocketing profits ranging from 59 to 1500 per cent on the manufacturing cost.

Intraocular lens are used for cataract surgeries to improve sharpness of vision.

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 Rs 350 and goes up till Rs 15,200 for a lens. The cost to the patient, however, ranges between Rs 5,800 to Rs 26,550. The profit, according to the FDA report accessed by 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 Rs 2,737 in India. Its selling price for wholesalers is Rs 6,500, but the cost to patients at the MRP is Rs 18,500, almost seven times higher than the landing cost.

In case of Ultima Plus Natural, manufactured by Care Group, the hospital purchased it for Rs 1,500, while its MRP was Rs 9,500, at a profit of 533 per cent.

The FDA report, sent to the Maharashtra government, the Drug Controller General of India (DCGI) and the National Pharmaceutical Pricing Authority (NPPA), has stated that intraocular lens must be included in the definition of ‘drug’ under Drug Price Control Order 2013. “Due to non regulation on price of intraocular lens, there is huge difference between charges taken from patients. Patients are suffering from financial burden/loss,” the report said.

While some hospitals sold the lens at MRP, other hospitals sold it below MRP to show a discounted price value, the FDA said.

According to the US journal ‘National Center for Biotechnology Information (NCBI)’, India conducted 3.5 million cataract surgeries in 2000. It is estimated the cataract operations in India have now risen beyond 10 million a year. In Maharashtra alone, the Directorate of Health Services recorded 6.96 lakh cataract surgeries in public and private sectors in 2016-17, of which 3.85 lakh were conducted by private doctors.

“Intraocular lenses were introduced for cataract operations about 40 years ago. They prevent lifelong use of thick spectacles after surgery,” said Dr Ragini Parekh, head of ophthalmology at JJ hospital. Dr Parekh said that doctors in public hospitals had been demanding price control of this essential commodity, as they usually charge the minimum price or offer the lens for free to poor patients. The lenses are made of different materials, which changes their cost.

The state FDA has now asked the government to introduce intraocular lenses under National List of Essential Medicines. In 2005, these lenses were notified as medical devices.

“Currently there is no price cap on lenses. Profit margins are so huge in this industry, specially for hospitals, that we felt there is a need to bring in some regulation,” outgoing FDA commissioner Harshdeep Kamble told The Indian Express.

Of the 15 lenses studied by the FDA, six were from Alcon (Novartis company), seven from Care Group, and two from Appasamy Associates. In India, most intraocular lenses are imported from the US, Germany and the UK.

Appasamy, headquartered in Chennai, imports raw material from US and UK and processes intraocular lens in India. A spokesperson claimed they are in talks with the government over price regulation. “We cannot comment until the government takes a decision,” the spokesperson from Appasamy Associates said.

When contacted, Care Group’s equipment division director Vipin Duggal said, “The government can take a decision and we’ll abide by whatever policy is made. There is no huge profit margin in lenses.”

In a response to an email, the Alcon spokesperson did not comment over profit margins or the FDA report, stating, “Alcon lenses address the different needs of patients and therefore offer physicians and patients choice in their intraocular lenses; so we offer the simpler monofocal lens to the more technologically advanced and complex Toric lenses. At Alcon, our mission is to enhance sight and improve lives. This desire drives our relentless commitment to patient safety and manufacturing high quality products.”

In November 2016, Maharashtra FDA along with Director of Health Services, Legal Metrology and Director of Medical Education submitted a report that showed 18 surgical equipment and medical devices were charged a cost much higher than at what was supplied to hospitals.

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