Include 18 medical devices among drugs, cap prices: FDA

Another FDA report shows how private hospitals allegedly gain a profit margin of 200-500 per cent on routine medical instruments such as urinary bags, disposable syringes, needles and oxygen masks, among a list of 18 medical items.

Written by Tabassum Barnagarwala | Mumbai | Published:June 24, 2017 2:42 am
fda, essential medicines, pharmaceutical pricing The national regulatory body has already capped prices of stents used in angioplasty procedures. (Representational image)

In an attempt to introduce price control regulations for a range of surgical equipment, Maharashtra Food and Drug Administration (FDA) has submitted a report to the Centre and the National Pharmaceutical Pricing Authority (NPPA) to notify at least 18 surgical and non-surgical instruments as drugs and include them under the National List of Essential Medicines.

The national regulatory body has already capped prices of stents used in angioplasty procedures. A recent report by the FDA highlighted the huge profiteering by hospitals over the prices of balloons, guiding catheters and intraocular lenses.

Another FDA report shows how private hospitals allegedly gain a profit margin of 200-500 per cent on routine medical instruments such as urinary bags, disposable syringes, needles and oxygen masks, among a list of 18 medical items.

The report, accessed by The Indian Express, says that a disposable syringe with needle costs the hospital between Rs 2.85 to Rs 13. The Maximum Retail Price (MRP) at which the hospitals can sell it to a patient is Rs 90, at a profit of 592 per cent.

Similarly, an oxygen mask costs the hospital Rs 80 and is sold to the patient for Rs 1,100, at 280 per cent profit. On N95 masks used against bird flu, hospitals can make a profit up to 140 per cent, while for urinary bags, the margin is 471 per cent. A 1000-ml urinary bag is sold at Rs 80. Its cost to the hospital is Rs 14.

“Patients do not know about what a surgical or non-surgical item costs or what profit a hospital is making on it. In our study, we invited government hospitals to submit the cost at which they buy each surgical instrumentans the MRP labelled on it,” an assistant commissioner of drugs,FDA, said.

The report lists other surgical instruments such as fistula needles, aspiration needles, rebreathing bags, face masks, oxegenator, arterial catheter set, absorbable gelatin, antimicrobial incise drape, disposable endotracheal tubes, incise drape and lenses.

According to the report, prepared in December 2016, the FDA recommended to the NPPA and the central government that the instruments first be notified as drugs. A price cap can only be introduced if the instrument is listed under Drug Price Control Order (DPCO), 2013, followed by inclusion in the National list of Essential Medicines.

The study was commissioned by former FDA commissioner Harshdeep Kamble. “We are waiting for the NPPA to list this in their agenda and consider all such surgical instruments,” said commissioner Pallavi Darade. The proposal comes under Drugs and Cosmetic Act, 1945. “Such instruments, in regular use by patients, must be notified and their prices regulated,” the FDA report stated.

According to Dr A K Gwalani, head of surgery at KEM hospital, disposable syringes are used in bulk for blood collection or to inject a patient with some drug. “Aspiration needles are generally used for biopsy or to remove puss. Even urinary bags are routinely used post operation for patients. In government hospitals, poor patients are not charged for it,” he said.

While cost of these routine instruments are lower than stents or catheters, private hospitals earn huge profits due to large volume in sales.

NPPA officials said currently, notified drugs are being scrutinised to deliberate on price control. “The health ministry first needs to notify these items as drugs. Only then can the process to include them in DPCO or Essential list can be undertaken,” an NPPA official said.

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